Trial Outcomes & Findings for Clinical and Health Economic Evaluation With a New Baha® Abutment Combined With a Minimally Invasive Surgical Technique (NCT NCT01796236)

NCT ID: NCT01796236

Last Updated: 2019-02-26

Results Overview

Combined endpoint of infection/inflammation, overgrowth, pain and numbness will be evaluated, as the sum of the following four events: 1. Holgers Index \>=2 any time between 3 weeks to 1 year 2. Any overgrowth any time between 3 weeks to 1 year 3. Pain (scar/neuropathic) according to POSAS \>=3 any time between 3 weeks to 1 year 4. Any numbness any time between 3 weeks to 1 year Each medical event is counted only once per subject resulting in a score of 0 to 4 for every subject.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 106 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2019-02-26

Participant Flow

106 subjects signed informed consent. Before surgery one subject cancelled surgery, one subject withdraw consent and one subject got the wrong allocation due to logistic problems. This resulted in that 103 subjects received the allocated intervention (51 test and 52 control).

Participant milestones

Measure	Minimally Invasive Surgery and BA400 This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)	Traditional Surgery and BA300 This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Overall Study STARTED	51	52
Overall Study COMPLETED	49	50
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical and Health Economic Evaluation With a New Baha® Abutment Combined With a Minimally Invasive Surgical Technique

Baseline characteristics by cohort

Measure	Minimally Invasive Surgery and BA400 n=51 Participants This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)	Traditional Surgery and BA300 n=52 Participants This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).	Total n=103 Participants Total of all reporting groups
Age, Continuous	54.2 years STANDARD_DEVIATION 10.9 • n=5 Participants	51.5 years STANDARD_DEVIATION 16.6 • n=7 Participants	52.4 years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Region of Enrollment Netherlands	26 participants n=5 Participants	29 participants n=7 Participants	55 participants n=5 Participants
Region of Enrollment Sweden	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants
Region of Enrollment France	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment Spain	15 participants n=5 Participants	14 participants n=7 Participants	29 participants n=5 Participants
Use of nicotine No	37 participants n=5 Participants	38 participants n=7 Participants	75 participants n=5 Participants
Use of nicotine Yes	14 participants n=5 Participants	13 participants n=7 Participants	27 participants n=5 Participants
Use of nicotine Unknown	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Type of hearing loss Conductive	5 participants n=5 Participants	10 participants n=7 Participants	15 participants n=5 Participants
Type of hearing loss Mixed	31 participants n=5 Participants	35 participants n=7 Participants	66 participants n=5 Participants
Type of hearing loss Single-Sided Sensorineural	15 participants n=5 Participants	7 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.

Combined endpoint of infection/inflammation, overgrowth, pain and numbness will be evaluated, as the sum of the following four events:

1. Holgers Index >=2 any time between 3 weeks to 1 year

2. Any overgrowth any time between 3 weeks to 1 year

3. Pain (scar/neuropathic) according to POSAS >=3 any time between 3 weeks to 1 year

4. Any numbness any time between 3 weeks to 1 year Each medical event is counted only once per subject resulting in a score of 0 to 4 for every subject.

Outcome measures

Measure	Minimally Invasive Surgery and BA400 n=51 Participants This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).	Traditional Surgery and BA300 n=52 Participants This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability Combined endpoint score = 1	14 participants	13 participants
Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability Combined endpoint score = 2	14 participants	24 participants
Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability Combined endpoint score = 3	7 participants	8 participants
Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability Combined endpoint score = 4	1 participants	0 participants
Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability Combined endpoint score = 0	15 participants	7 participants

PRIMARY outcome

Timeframe: 36 months

Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.

Combined endpoint of infection/inflammation, overgrowth, pain and numbness will be evaluated, as the sum of the following four events:

1. Holgers Index >=2 any time between 3 weeks to 1 year

2. Any overgrowth any time between 3 weeks to 1 year

3. Pain (scar/neuropathic) according to POSAS >=3 any time between 3 weeks to 1 year

4. Any numbness any time between 3 weeks to 1 year Each medical event is counted only once per subject resulting in a score of 0 to 4 for every subject.

Outcome measures

Measure	Minimally Invasive Surgery and BA400 n=51 Participants This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).	Traditional Surgery and BA300 n=52 Participants This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability Combined endpoint score = 3	9 participants	8 participants
Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability Combined endpoint score = 0	12 participants	5 participants
Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability Combined endpoint score = 1	12 participants	15 participants
Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability Combined endpoint score = 2	16 participants	23 participants
Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability Combined endpoint score = 4	2 participants	1 participants

SECONDARY outcome

Timeframe: Day 0

Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.

Surgery time (minutes) was recorded

Outcome measures

Measure	Minimally Invasive Surgery and BA400 n=51 Participants This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).	Traditional Surgery and BA300 n=52 Participants This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Surgery Time	15.3 minutes Standard Deviation 6.2	24.7 minutes Standard Deviation 8.6

SECONDARY outcome

Timeframe: Day 10, Weeks 3, 6, 12 and 24

Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.

A surgeon or a surgical nurse determined if the wound was healed or not healed.

Outcome measures

Measure	Minimally Invasive Surgery and BA400 n=51 Participants This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).	Traditional Surgery and BA300 n=52 Participants This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Wound Healing Week 24, Wound healed	47 participants	46 participants
Wound Healing Day 10, Wound not healed	4 participants	14 participants
Wound Healing Day 10, Wound healed	47 participants	38 participants
Wound Healing Week 3, Wound not healed	4 participants	8 participants
Wound Healing Week 3, Wound healed	46 participants	44 participants
Wound Healing Week 6, Wound not healed	3 participants	3 participants
Wound Healing Week 6, Wound healed	47 participants	48 participants
Wound Healing Week 12, Wound not healed	1 participants	0 participants
Wound Healing Week 12, Wound healed	46 participants	50 participants
Wound Healing Week 24, Wound not healed	0 participants	0 participants

SECONDARY outcome

Timeframe: From Day 10 to 12 Months, and to 36 Months

Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.

Max of Holgers index from day 10 to month 12, and to month 36 was recorded, using the Holgers scale from 0 - 4, where 0 = no inflammation and 4 = removal of abutment/implant necessary due to infection.

0. No irritation

1. Slight redness. Local temporary treatment, if needed

2. Red and slightly moist tissue. No granulation formation, local treatment and extra controls as indicated*

3. Reddish and moist; sometimes granulations tissue, revision surgery is indicated* R. Removal of the abutment / implant necessary due to infection* R Removal of implant for reasons not related to skin problems*

Outcome measures

Measure	Minimally Invasive Surgery and BA400 n=51 Participants This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).	Traditional Surgery and BA300 n=52 Participants This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Inflammation - Max of Holgers Index Max of Holgers 36 Months · Max of Holgers index = 4	1 Participants	0 Participants
Inflammation - Max of Holgers Index Max of Holgers 12 Months · Max of Holgers index = 0	10 Participants	8 Participants
Inflammation - Max of Holgers Index Max of Holgers 12 Months · Max of Holgers index = 1	26 Participants	32 Participants
Inflammation - Max of Holgers Index Max of Holgers 12 Months · Max of Holgers index = 2	7 Participants	10 Participants
Inflammation - Max of Holgers Index Max of Holgers 12 Months · Max of Holgers index = 3	8 Participants	2 Participants
Inflammation - Max of Holgers Index Max of Holgers 12 Months · Max of Holgers index = 4	0 Participants	0 Participants
Inflammation - Max of Holgers Index Max of Holgers 36 Months · Max of Holgers index = 0	9 Participants	8 Participants
Inflammation - Max of Holgers Index Max of Holgers 36 Months · Max of Holgers index = 1	23 Participants	31 Participants
Inflammation - Max of Holgers Index Max of Holgers 36 Months · Max of Holgers index = 2	7 Participants	9 Participants
Inflammation - Max of Holgers Index Max of Holgers 36 Months · Max of Holgers index = 3	11 Participants	4 Participants

SECONDARY outcome

Timeframe: Day 10, Weeks 3, 6, 12, 24, months 12, 24 and 36

Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 through to month 36.

Infection and inflammation were evaluated by the holgers index at visits 3-10 (Day 10, Weeks 3, 6, 12, 24, months 12, 24 and 36) and the following scale was used:

0. No irritation. Epidermal debris removed, if present

1. Slight redness. Local temporary treatment, if needed

2. Red and slightly moist tissue. No granulation formation, local treatment and extra controls as indicated*

3. Reddish and moist; sometimes granulations tissue, revision surgery is indicated*

4. Removal of the abutment / implant necessary due to infection* R. Removal of implant for reasons not related to skin problems*

Outcome measures

Measure	Minimally Invasive Surgery and BA400 n=51 Participants This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).	Traditional Surgery and BA300 n=52 Participants This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Inflammation - Holgers Index by Visit Day 10 · Holgers 0	32 Participants	35 Participants
Inflammation - Holgers Index by Visit Day 10 · Holgers 1	15 Participants	15 Participants
Inflammation - Holgers Index by Visit Day 10 · Holgers 2	2 Participants	2 Participants
Inflammation - Holgers Index by Visit Day 10 · Holgers 3	2 Participants	0 Participants
Inflammation - Holgers Index by Visit Day 10 · Holgers 4/ Removal	0 Participants	0 Participants
Inflammation - Holgers Index by Visit Week 3 · Holgers 0	27 Participants	33 Participants
Inflammation - Holgers Index by Visit Week 3 · Holgers 1	17 Participants	16 Participants
Inflammation - Holgers Index by Visit Week 3 · Holgers 2	2 Participants	2 Participants
Inflammation - Holgers Index by Visit Week 3 · Holgers 3	4 Participants	1 Participants
Inflammation - Holgers Index by Visit Week 3 · Holgers 4/ Removal	0 Participants	0 Participants
Inflammation - Holgers Index by Visit Week 6 · Holgers 0	32 Participants	29 Participants
Inflammation - Holgers Index by Visit Week 6 · Holgers 1	17 Participants	18 Participants
Inflammation - Holgers Index by Visit Week 6 · Holgers 2	0 Participants	3 Participants
Inflammation - Holgers Index by Visit Week 6 · Holgers 3	0 Participants	1 Participants
Inflammation - Holgers Index by Visit Week 6 · Holgers 4/ Removal	1 Participants	0 Participants
Inflammation - Holgers Index by Visit Week 12 · Holgers 0	33 Participants	36 Participants
Inflammation - Holgers Index by Visit Week 12 · Holgers 1	11 Participants	12 Participants
Inflammation - Holgers Index by Visit Week 12 · Holgers 2	3 Participants	2 Participants
Inflammation - Holgers Index by Visit Week 12 · Holgers 3	0 Participants	0 Participants
Inflammation - Holgers Index by Visit Week 12 · Holgers 4/ Removal	0 Participants	0 Participants
Inflammation - Holgers Index by Visit Week 24 · Holgers 0	32 Participants	27 Participants
Inflammation - Holgers Index by Visit Week 24 · Holgers 1	13 Participants	17 Participants
Inflammation - Holgers Index by Visit Week 24 · Holgers 2	2 Participants	2 Participants
Inflammation - Holgers Index by Visit Week 24 · Holgers 3	0 Participants	0 Participants
Inflammation - Holgers Index by Visit Week 24 · Holgers 4/ Removal	0 Participants	0 Participants
Inflammation - Holgers Index by Visit Month 12 · Holgers 0	41 Participants	39 Participants
Inflammation - Holgers Index by Visit Month 12 · Holgers 1	4 Participants	9 Participants
Inflammation - Holgers Index by Visit Month 12 · Holgers 2	1 Participants	0 Participants
Inflammation - Holgers Index by Visit Month 12 · Holgers 3	2 Participants	0 Participants
Inflammation - Holgers Index by Visit Month 12 · Holgers 4/ Removal	0 Participants	0 Participants
Inflammation - Holgers Index by Visit Month 24 · Holgers 0	37 Participants	40 Participants
Inflammation - Holgers Index by Visit Month 24 · Holgers 1	8 Participants	6 Participants
Inflammation - Holgers Index by Visit Month 24 · Holgers 2	0 Participants	0 Participants
Inflammation - Holgers Index by Visit Month 24 · Holgers 3	0 Participants	0 Participants
Inflammation - Holgers Index by Visit Month 24 · Holgers 4/ Removal	1 Participants	0 Participants
Inflammation - Holgers Index by Visit Month 36 · Holgers 0	38 Participants	37 Participants
Inflammation - Holgers Index by Visit Month 36 · Holgers 1	5 Participants	2 Participants
Inflammation - Holgers Index by Visit Month 36 · Holgers 2	0 Participants	0 Participants
Inflammation - Holgers Index by Visit Month 36 · Holgers 3	2 Participants	2 Participants
Inflammation - Holgers Index by Visit Month 36 · Holgers 4/ Removal	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 & 36 months

Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.

Subjects were asked if they experience any numbness around the abutment at each visit. The maximum numbness each subject experienced is summarized in this analysis. The following scale will be used:

1. No numbness

2. Numbness within 2 cm from the abutment

3. Numbness within and beyond 2 cm from the abutment

Outcome measures

Measure	Minimally Invasive Surgery and BA400 n=51 Participants This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).	Traditional Surgery and BA300 n=52 Participants This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Max Numbness Max Numbness 12 months · No numbness	27 Participants	9 Participants
Max Numbness Max Numbness 12 months · Numbness within 2 cm from the abutment	17 Participants	12 Participants
Max Numbness Max Numbness 12 months · Numbness within and beyond 2 cm from the abutment	7 Participants	31 Participants
Max Numbness Max Numbness 36 months · No numbness	27 Participants	9 Participants
Max Numbness Max Numbness 36 months · Numbness within 2 cm from the abutment	16 Participants	12 Participants
Max Numbness Max Numbness 36 months · Numbness within and beyond 2 cm from the abutment	8 Participants	31 Participants

SECONDARY outcome

Timeframe: Day 10, Weeks 3, 6, 12, 24, Months 12 and 36

Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and through until visit 10 Month 36.

The subject rated the following questions 'has the scar been painful the past few weeks' and 'have you had any neuropathic pain during the past weeks' on the 1-10 scale were 1 = no, not at all and 10 = yes, very much.

Outcome measures

Measure	Minimally Invasive Surgery and BA400 n=51 Participants This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).	Traditional Surgery and BA300 n=52 Participants This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Pain in the Scar and Neuropathic Pain Day 10, Neuropathic pain	1.45 units on a scale Standard Deviation 1.47	1.65 units on a scale Standard Deviation 1.75
Pain in the Scar and Neuropathic Pain Day 10, Scar pain	1.90 units on a scale Standard Deviation 1.94	2.08 units on a scale Standard Deviation 1.64
Pain in the Scar and Neuropathic Pain Week 3, Neuropathic pain	1.38 units on a scale Standard Deviation 1.26	1.75 units on a scale Standard Deviation 1.43
Pain in the Scar and Neuropathic Pain Week 3, Scar pain	1.78 units on a scale Standard Deviation 1.52	1.71 units on a scale Standard Deviation 1.24
Pain in the Scar and Neuropathic Pain Week 6, Neuropathic pain	1.18 units on a scale Standard Deviation 0.72	1.45 units on a scale Standard Deviation 1.19
Pain in the Scar and Neuropathic Pain Week 6, Scar pain	1.58 units on a scale Standard Deviation 1.14	1.80 units on a scale Standard Deviation 1.34
Pain in the Scar and Neuropathic Pain Week 12, Neuropathic pain	1.06 units on a scale Standard Deviation 0.25	1.70 units on a scale Standard Deviation 1.53
Pain in the Scar and Neuropathic Pain Week 12, Scar pain	2.00 units on a scale Standard Deviation 1.41	2.06 units on a scale Standard Deviation 1.63
Pain in the Scar and Neuropathic Pain Week 24, Neuropathic pain	1.19 units on a scale Standard Deviation 0.82	1.41 units on a scale Standard Deviation 1.48
Pain in the Scar and Neuropathic Pain Week 24, Scar pain	1.70 units on a scale Standard Deviation 1.25	2.02 units on a scale Standard Deviation 1.72
Pain in the Scar and Neuropathic Pain Month 12, Neuropathic pain	1.26 units on a scale Standard Deviation 1.05	1.77 units on a scale Standard Deviation 1.97
Pain in the Scar and Neuropathic Pain Month 12, Scar pain	2.04 units on a scale Standard Deviation 2.01	2.02 units on a scale Standard Deviation 1.93
Pain in the Scar and Neuropathic Pain Month 36, Neuropathic pain	1.11 units on a scale Standard Deviation 0.53	1.39 units on a scale Standard Deviation 1.14
Pain in the Scar and Neuropathic Pain Month 36, Scar pain	1.98 units on a scale Standard Deviation 1.88	2.05 units on a scale Standard Deviation 1.83

SECONDARY outcome

Timeframe: 12 months

Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.

The maximum neuropathic pain and the maximum scar pain experienced at any time throughout the study up until and including 12 months.

Outcome measures

Measure	Minimally Invasive Surgery and BA400 n=51 Participants This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).	Traditional Surgery and BA300 n=52 Participants This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Pain - Maximum of Neuropathic and Scar Pain Neuropathic Pain · 1 - No Pain	34 Participants	27 Participants
Pain - Maximum of Neuropathic and Scar Pain Neuropathic Pain · 2-3 - Mild Pain	7 Participants	8 Participants
Pain - Maximum of Neuropathic and Scar Pain Neuropathic Pain · 4-6 - Moderate Pain	7 Participants	9 Participants
Pain - Maximum of Neuropathic and Scar Pain Neuropathic Pain · 7-10 - Severe Pain	3 Participants	8 Participants
Pain - Maximum of Neuropathic and Scar Pain Scar Pain · 1 - No Pain	10 Participants	10 Participants
Pain - Maximum of Neuropathic and Scar Pain Scar Pain · 2-3 - Mild Pain	22 Participants	15 Participants
Pain - Maximum of Neuropathic and Scar Pain Scar Pain · 4-6 - Moderate Pain	12 Participants	21 Participants
Pain - Maximum of Neuropathic and Scar Pain Scar Pain · 7-10 - Severe Pain	7 Participants	6 Participants

SECONDARY outcome

Timeframe: 36 months

Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.

The maximum neuropathic pain and the maximum scar pain experienced at any time throughout the study up until and including 36 months.

Outcome measures

Measure	Minimally Invasive Surgery and BA400 n=51 Participants This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).	Traditional Surgery and BA300 n=52 Participants This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Pain - Maximum of Neuropathic and Scar Pain Neuropathic Pain · 1 - No Pain	34 Participants	27 Participants
Pain - Maximum of Neuropathic and Scar Pain Neuropathic Pain · 2-3 - Mild Pain	7 Participants	8 Participants
Pain - Maximum of Neuropathic and Scar Pain Neuropathic Pain · 4-6 - Moderate Pain	7 Participants	9 Participants
Pain - Maximum of Neuropathic and Scar Pain Neuropathic Pain · 7-10 - Severe Pain	3 Participants	8 Participants
Pain - Maximum of Neuropathic and Scar Pain Scar Pain · 1 - No Pain	9 Participants	9 Participants
Pain - Maximum of Neuropathic and Scar Pain Scar Pain · 2-3 - Mild Pain	20 Participants	14 Participants
Pain - Maximum of Neuropathic and Scar Pain Scar Pain · 4-6 - Moderate Pain	13 Participants	23 Participants
Pain - Maximum of Neuropathic and Scar Pain Scar Pain · 7-10 - Severe Pain	9 Participants	6 Participants

SECONDARY outcome

Timeframe: Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36

Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and through until visit 10 Month 36.

The subject rated the following questions 'has the scar been painful the past few weeks' and 'have you had any neuropathic pain during the past weeks' on the 1-10 scale were 1 = no, not at all and 10 = yes, very much.

Pain scale was categorised as 1='no pain', 2-3='mild pain', 4-6='moderate pain', 7-10='severe pain'.

Outcome measures

Measure	Minimally Invasive Surgery and BA400 n=51 Participants This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).	Traditional Surgery and BA300 n=52 Participants This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Pain by Visit - Categorical Week 3: Neuropathic pain · 4-6: Moderate Pain	3 Participants	4 Participants
Pain by Visit - Categorical Week 3: Neuropathic pain · 7-10: Severe Pain	1 Participants	1 Participants
Pain by Visit - Categorical Week 3: Scar pain · 1: No Pain	33 Participants	34 Participants
Pain by Visit - Categorical Week 3: Scar pain · 2-3: Mild Pain	11 Participants	14 Participants
Pain by Visit - Categorical Week 3: Scar pain · 4-6: Moderate Pain	4 Participants	4 Participants
Pain by Visit - Categorical Week 3: Scar pain · 7-10: Severe Pain	2 Participants	0 Participants
Pain by Visit - Categorical Week 6: Neuropathic pain · 1: No Pain	46 Participants	42 Participants
Pain by Visit - Categorical Week 6: Neuropathic pain · 2-3: Mild Pain	2 Participants	5 Participants
Pain by Visit - Categorical Week 6: Neuropathic pain · 4-6: Moderate Pain	2 Participants	3 Participants
Pain by Visit - Categorical Week 6: Neuropathic pain · 7-10: Severe Pain	0 Participants	1 Participants
Pain by Visit - Categorical Week 6: Scar pain · 1: No Pain	35 Participants	32 Participants
Pain by Visit - Categorical Week 6: Scar pain · 2-3: Mild Pain	10 Participants	13 Participants
Pain by Visit - Categorical Week 6: Scar pain · 4-6: Moderate Pain	5 Participants	5 Participants
Pain by Visit - Categorical Week 6: Scar pain · 7-10: Severe Pain	0 Participants	1 Participants
Pain by Visit - Categorical Week 12: Neuropathic pain · 1: No Pain	44 Participants	36 Participants
Pain by Visit - Categorical Week 12: Neuropathic pain · 2-3: Mild Pain	3 Participants	5 Participants
Pain by Visit - Categorical Week 12: Neuropathic pain · 4-6: Moderate Pain	0 Participants	5 Participants
Pain by Visit - Categorical Month 12: Neuropathic pain · 1: No Pain	43 Participants	40 Participants
Pain by Visit - Categorical Week 12: Scar pain · 1: No Pain	25 Participants	30 Participants
Pain by Visit - Categorical Week 12: Scar pain · 2-3: Mild Pain	16 Participants	9 Participants
Pain by Visit - Categorical Week 12: Scar pain · 4-6: Moderate Pain	5 Participants	8 Participants
Pain by Visit - Categorical Week 12: Scar pain · 7-10: Severe Pain	1 Participants	1 Participants
Pain by Visit - Categorical Week 24: Neuropathic pain · 1: No Pain	44 Participants	41 Participants
Pain by Visit - Categorical Week 24: Neuropathic pain · 2-3: Mild Pain	1 Participants	3 Participants
Pain by Visit - Categorical Week 24: Neuropathic pain · 4-6: Moderate Pain	2 Participants	0 Participants
Pain by Visit - Categorical Month 36: Neuropathic pain · 7-10: Severe Pain	0 Participants	0 Participants
Pain by Visit - Categorical Month 36: Scar pain · 1: No Pain	28 Participants	25 Participants
Pain by Visit - Categorical Week 12: Neuropathic pain · 7-10: Severe Pain	0 Participants	1 Participants
Pain by Visit - Categorical Week 24: Neuropathic pain · 7-10: Severe Pain	0 Participants	2 Participants
Pain by Visit - Categorical Week 24: Scar pain · 1: No Pain	33 Participants	29 Participants
Pain by Visit - Categorical Week 24: Scar pain · 2-3: Mild Pain	8 Participants	9 Participants
Pain by Visit - Categorical Week 24: Scar pain · 4-6: Moderate Pain	6 Participants	6 Participants
Pain by Visit - Categorical Week 24: Scar pain · 7-10: Severe Pain	0 Participants	2 Participants
Pain by Visit - Categorical Month 12: Neuropathic pain · 2-3: Mild Pain	2 Participants	1 Participants
Pain by Visit - Categorical Month 12: Neuropathic pain · 4-6: Moderate Pain	1 Participants	4 Participants
Pain by Visit - Categorical Month 12: Neuropathic pain · 7-10: Severe Pain	1 Participants	3 Participants
Pain by Visit - Categorical Month 12: Scar pain · 1: No Pain	30 Participants	31 Participants
Pain by Visit - Categorical Month 12: Scar pain · 2-3: Mild Pain	11 Participants	10 Participants
Pain by Visit - Categorical Month 12: Scar pain · 4-6: Moderate Pain	2 Participants	3 Participants
Pain by Visit - Categorical Month 12: Scar pain · 7-10: Severe Pain	4 Participants	3 Participants
Pain by Visit - Categorical Month 36: Neuropathic pain · 1: No Pain	43 Participants	36 Participants
Pain by Visit - Categorical Month 36: Neuropathic pain · 2-3: Mild Pain	1 Participants	2 Participants
Pain by Visit - Categorical Month 36: Scar pain · 2-3: Mild Pain	12 Participants	10 Participants
Pain by Visit - Categorical Month 36: Scar pain · 4-6: Moderate Pain	3 Participants	4 Participants
Pain by Visit - Categorical Month 36: Scar pain · 7-10: Severe Pain	2 Participants	2 Participants
Pain by Visit - Categorical Month 36: Neuropathic pain · 4-6: Moderate Pain	1 Participants	3 Participants
Pain by Visit - Categorical Day 10: Neuropathic pain · 1: No Pain	43 Participants	43 Participants
Pain by Visit - Categorical Day 10: Neuropathic pain · 2-3: Mild Pain	5 Participants	4 Participants
Pain by Visit - Categorical Day 10: Neuropathic pain · 4-6: Moderate Pain	2 Participants	2 Participants
Pain by Visit - Categorical Day 10: Neuropathic pain · 7-10: Severe Pain	1 Participants	3 Participants
Pain by Visit - Categorical Day 10: Scar pain · 1: No Pain	35 Participants	32 Participants
Pain by Visit - Categorical Day 10: Scar pain · 2-3: Mild Pain	10 Participants	10 Participants
Pain by Visit - Categorical Day 10: Scar pain · 4-6: Moderate Pain	4 Participants	9 Participants
Pain by Visit - Categorical Day 10: Scar pain · 7-10: Severe Pain	2 Participants	1 Participants
Pain by Visit - Categorical Week 3: Neuropathic pain · 1: No Pain	44 Participants	36 Participants
Pain by Visit - Categorical Week 3: Neuropathic pain · 2-3: Mild Pain	2 Participants	11 Participants

SECONDARY outcome

Timeframe: Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36

Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.

The investigator rated the implant site in regards to soft tissue thickening/overgrowth at visits 3-10 according to the following scale:

0. No soft tissue thickening or overgrowth

1. Slight soft tissue thickening or overgrowth

2. Moderate soft tissue thickening or overgrowth. Local treatment and extra controls as indicated*

3. Marked/distinct soft tissue thickening or overgrowth. Revision surgery is indicated.*

• Should also be reported on the AE page in the CRF

Outcome measures

Measure	Minimally Invasive Surgery and BA400 n=51 Participants This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).	Traditional Surgery and BA300 n=52 Participants This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Soft Tissue Thickening/Overgrowth Week 6 · Moderate soft tissue thickening or overgrowth	0 Participants	0 Participants
Soft Tissue Thickening/Overgrowth Day 10 · No soft tissue thickening	48 Participants	52 Participants
Soft Tissue Thickening/Overgrowth Day 10 · Slight soft tissue thickening or overgrowth	2 Participants	0 Participants
Soft Tissue Thickening/Overgrowth Day 10 · Moderate soft tissue thickening or overgrowth	1 Participants	0 Participants
Soft Tissue Thickening/Overgrowth Day 10 · Marked/distinct soft tissue thickening or overgrow	0 Participants	0 Participants
Soft Tissue Thickening/Overgrowth Week 3 · No soft tissue thickening	41 Participants	50 Participants
Soft Tissue Thickening/Overgrowth Week 3 · Slight soft tissue thickening or overgrowth	6 Participants	2 Participants
Soft Tissue Thickening/Overgrowth Week 3 · Moderate soft tissue thickening or overgrowth	2 Participants	0 Participants
Soft Tissue Thickening/Overgrowth Week 3 · Marked/distinct soft tissue thickening or overgrow	1 Participants	0 Participants
Soft Tissue Thickening/Overgrowth Week 6 · No soft tissue thickening	48 Participants	48 Participants
Soft Tissue Thickening/Overgrowth Week 6 · Slight soft tissue thickening or overgrowth	1 Participants	3 Participants
Soft Tissue Thickening/Overgrowth Week 24 · Marked/distinct soft tissue thickening or overgrow	0 Participants	0 Participants
Soft Tissue Thickening/Overgrowth Month 12 · No soft tissue thickening	44 Participants	44 Participants
Soft Tissue Thickening/Overgrowth Month 12 · Slight soft tissue thickening or overgrowth	1 Participants	4 Participants
Soft Tissue Thickening/Overgrowth Month 12 · Moderate soft tissue thickening or overgrowth	3 Participants	0 Participants
Soft Tissue Thickening/Overgrowth Month 12 · Marked/distinct soft tissue thickening or overgrow	0 Participants	0 Participants
Soft Tissue Thickening/Overgrowth Month 24 · No soft tissue thickening	39 Participants	41 Participants
Soft Tissue Thickening/Overgrowth Week 6 · Marked/distinct soft tissue thickening or overgrow	1 Participants	0 Participants
Soft Tissue Thickening/Overgrowth Week 12 · No soft tissue thickening	43 Participants	43 Participants
Soft Tissue Thickening/Overgrowth Week 12 · Slight soft tissue thickening or overgrowth	4 Participants	7 Participants
Soft Tissue Thickening/Overgrowth Week 12 · Moderate soft tissue thickening or overgrowth	0 Participants	0 Participants
Soft Tissue Thickening/Overgrowth Week 12 · Marked/distinct soft tissue thickening or overgrow	0 Participants	0 Participants
Soft Tissue Thickening/Overgrowth Week 24 · No soft tissue thickening	38 Participants	42 Participants
Soft Tissue Thickening/Overgrowth Week 24 · Slight soft tissue thickening or overgrowth	8 Participants	4 Participants
Soft Tissue Thickening/Overgrowth Month 24 · Slight soft tissue thickening or overgrowth	6 Participants	4 Participants
Soft Tissue Thickening/Overgrowth Week 24 · Moderate soft tissue thickening or overgrowth	1 Participants	0 Participants
Soft Tissue Thickening/Overgrowth Month 24 · Moderate soft tissue thickening or overgrowth	1 Participants	1 Participants
Soft Tissue Thickening/Overgrowth Month 24 · Marked/distinct soft tissue thickening or overgrow	0 Participants	0 Participants
Soft Tissue Thickening/Overgrowth Month 36 · No soft tissue thickening	39 Participants	37 Participants
Soft Tissue Thickening/Overgrowth Month 36 · Slight soft tissue thickening or overgrowth	6 Participants	2 Participants
Soft Tissue Thickening/Overgrowth Month 36 · Moderate soft tissue thickening or overgrowth	0 Participants	2 Participants
Soft Tissue Thickening/Overgrowth Month 36 · Marked/distinct soft tissue thickening or overgrow	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36

Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 through to visit 10 Month 36. This analysis is performed on subjects with no change of abutment.

The investigator measured the visible abutment length at each visit. The length of BA400 test abutments initially placed were longer than BA300 control abutments places. A direct comparison between the groups is not relevant.

In some cases of increased soft tissue thickening or overgrowth, the abutment was exchanged for a longer abutment. The results presented here are only for patients with no change of abutment

Outcome measures

Measure	Minimally Invasive Surgery and BA400 n=48 Participants This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).	Traditional Surgery and BA300 n=47 Participants This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Visible Abutment Length by Visit for Patients With no Change of Abutment Month 12	4.33 millimeters visible abutment length Standard Deviation 1.52	3.72 millimeters visible abutment length Standard Deviation 1.20
Visible Abutment Length by Visit for Patients With no Change of Abutment Day 10	3.30 millimeters visible abutment length Standard Deviation 1.23	4.17 millimeters visible abutment length Standard Deviation 1.13
Visible Abutment Length by Visit for Patients With no Change of Abutment Month 24	3.90 millimeters visible abutment length Standard Deviation 1.61	3.56 millimeters visible abutment length Standard Deviation 1.25
Visible Abutment Length by Visit for Patients With no Change of Abutment Month 36	3.74 millimeters visible abutment length Standard Deviation 1.43	3.35 millimeters visible abutment length Standard Deviation 1.38
Visible Abutment Length by Visit for Patients With no Change of Abutment Week 3	3.34 millimeters visible abutment length Standard Deviation 1.18	3.91 millimeters visible abutment length Standard Deviation 1.04
Visible Abutment Length by Visit for Patients With no Change of Abutment Week 6	4.00 millimeters visible abutment length Standard Deviation 1.30	3.85 millimeters visible abutment length Standard Deviation 1.13
Visible Abutment Length by Visit for Patients With no Change of Abutment Week 12	3.73 millimeters visible abutment length Standard Deviation 1.35	3.51 millimeters visible abutment length Standard Deviation 1.27
Visible Abutment Length by Visit for Patients With no Change of Abutment Week 24	4.07 millimeters visible abutment length Standard Deviation 1.55	3.76 millimeters visible abutment length Standard Deviation 1.26

SECONDARY outcome

Timeframe: Week 12, Months 12 and 36

Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.

The patient scale contains six items (pain, itching, color, stiffness, thickness and irregularity) scored 1-10.

The observer scale contains six items (vascularity, pigmentation, thickness, relief, pliability and surface area) scored 1-10. Besides the 10-step scale, category boxes are available to score nominal parameters (e.g. type of color).

Both patient and observer should also score the overall opinion of the scar on the 1-10 scale.

For all above scales 1=normal skin, 10 worst scar imaginable.

Total score is the sum of the variables pain, itching, color, stiffness, thickness and irregularity (patient) and vascularity, pigmentation, thickness, relief, pliability and surface area (observer). The scale ranges from 6 to 60 (6 normal, 60 worst scar imaginable).

The "pain not with in the scar" variable ranges from 1 to 10. 1 being no pain at all and 10 being very much pain

Outcome measures

Measure	Minimally Invasive Surgery and BA400 n=51 Participants This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).	Traditional Surgery and BA300 n=52 Participants This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Week 12: Vascularity (observer)	2.11 units on a scale Standard Deviation 1.15	2.81 units on a scale Standard Deviation 1.54
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 12: Vascularity (observer)	1.98 units on a scale Standard Deviation 1.34	2.28 units on a scale Standard Deviation 1.48
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 36: Vascularity (observer)	1.69 units on a scale Standard Deviation 1.33	2.13 units on a scale Standard Deviation 1.49
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Week 12: Pigmentation (observer)	1.96 units on a scale Standard Deviation 1.16	2.21 units on a scale Standard Deviation 1.27
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 12: Pigmentation (observer)	1.69 units on a scale Standard Deviation 1.26	1.91 units on a scale Standard Deviation 1.21
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 36: Pigmentation (observer)	1.62 units on a scale Standard Deviation 1.01	2.03 units on a scale Standard Deviation 1.61
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Week 12: Thickness (observer)	2.26 units on a scale Standard Deviation 1.71	3.25 units on a scale Standard Deviation 1.49
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 12: Thickness (observer)	2.02 units on a scale Standard Deviation 1.52	2.72 units on a scale Standard Deviation 1.99
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 36: Thickness (observer)	2.02 units on a scale Standard Deviation 1.31	2.63 units on a scale Standard Deviation 1.85
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Week 12: Relief (observer)	2.11 units on a scale Standard Deviation 1.18	3.15 units on a scale Standard Deviation 1.56
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 12: Relief (observer)	1.96 units on a scale Standard Deviation 1.24	2.74 units on a scale Standard Deviation 1.87
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 36: Relief (observer)	1.93 units on a scale Standard Deviation 1.18	2.80 units on a scale Standard Deviation 1.86
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Week 12: Pliability (observer)	2.21 units on a scale Standard Deviation 1.10	3.23 units on a scale Standard Deviation 1.75
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 12: Pliability (observer)	2.08 units on a scale Standard Deviation 1.22	2.66 units on a scale Standard Deviation 1.70
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 36: Pliability (observer)	1.69 units on a scale Standard Deviation 1.06	2.58 units on a scale Standard Deviation 1.60
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Week 12: Surface Area (observer)	2.04 units on a scale Standard Deviation 1.12	3.06 units on a scale Standard Deviation 1.34
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 12: Surface Area (observer)	1.94 units on a scale Standard Deviation 1.28	2.68 units on a scale Standard Deviation 1.70
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 36: Surface Area (observer)	1.98 units on a scale Standard Deviation 1.11	2.68 units on a scale Standard Deviation 1.62
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Week 12: Total Score (observer)	12.7 units on a scale Standard Deviation 5.8	17.7 units on a scale Standard Deviation 7.4
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 12: Total Score (observer)	11.7 units on a scale Standard Deviation 6.9	15.0 units on a scale Standard Deviation 9.0
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 36: Total Score (observer)	10.9 units on a scale Standard Deviation 5.6	14.8 units on a scale Standard Deviation 8.9
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Week 12: Overall Opinion (observer)	2.28 units on a scale Standard Deviation 1.24	3.02 units on a scale Standard Deviation 1.22
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 12: Overall Opinion (observer)	2.00 units on a scale Standard Deviation 1.29	2.60 units on a scale Standard Deviation 1.65
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 36: Overall Opinion (observer)	1.93 units on a scale Standard Deviation 1.05	2.43 units on a scale Standard Deviation 1.52
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Week 12: Painful (patient)	2.00 units on a scale Standard Deviation 1.41	2.06 units on a scale Standard Deviation 1.63
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 12: Painful (patient)	2.04 units on a scale Standard Deviation 2.01	2.02 units on a scale Standard Deviation 1.93
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 36: Painful (patient)	1.98 units on a scale Standard Deviation 1.88	2.05 units on a scale Standard Deviation 1.83
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Week 12: Itching (patient)	2.49 units on a scale Standard Deviation 2.00	2.63 units on a scale Standard Deviation 2.07
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 12: Itching (patient)	2.43 units on a scale Standard Deviation 1.98	2.45 units on a scale Standard Deviation 2.09
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 36: Itching (patient)	2.42 units on a scale Standard Deviation 2.24	2.39 units on a scale Standard Deviation 2.07
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Week 12: Color (patient)	2.32 units on a scale Standard Deviation 1.49	2.06 units on a scale Standard Deviation 1.29
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 12: Color (patient)	1.78 units on a scale Standard Deviation 1.73	1.52 units on a scale Standard Deviation 1.24
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 36: Color (patient)	1.80 units on a scale Standard Deviation 1.96	1.58 units on a scale Standard Deviation 1.63
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Week 12: Stiffness (patient)	2.30 units on a scale Standard Deviation 1.71	2.47 units on a scale Standard Deviation 1.68
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 12: Stiffness (patient)	1.76 units on a scale Standard Deviation 1.75	1.87 units on a scale Standard Deviation 1.57
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 36: Stiffness (patient)	1.62 units on a scale Standard Deviation 1.61	2.05 units on a scale Standard Deviation 1.60
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Week 12: Thickness (patient)	2.35 units on a scale Standard Deviation 1.89	2.60 units on a scale Standard Deviation 1.64
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 12: Thickness (patient)	1.80 units on a scale Standard Deviation 1.85	1.89 units on a scale Standard Deviation 1.62
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 36: Thickness (patient)	2.09 units on a scale Standard Deviation 1.96	2.13 units on a scale Standard Deviation 1.68
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Week 12: Irregularity (patient)	2.89 units on a scale Standard Deviation 2.14	3.27 units on a scale Standard Deviation 2.07
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 12: Irregularity (patient)	1.87 units on a scale Standard Deviation 1.78	2.00 units on a scale Standard Deviation 1.68
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 36: Irregularity (patient)	1.89 units on a scale Standard Deviation 1.90	2.35 units on a scale Standard Deviation 1.97
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Week 12: Total Score (patient)	13.3 units on a scale Standard Deviation 7.6	15.1 units on a scale Standard Deviation 6.5
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 12: Total Score (patient)	11.7 units on a scale Standard Deviation 9.5	11.9 units on a scale Standard Deviation 8.1
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 36: Total Score (patient)	11.8 units on a scale Standard Deviation 10.1	12.6 units on a scale Standard Deviation 8.7
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Week 12: Overall Opinion (patient)	2.33 units on a scale Standard Deviation 1.69	2.81 units on a scale Standard Deviation 2.13
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 12: Overall Opinion (patient)	1.80 units on a scale Standard Deviation 1.31	2.15 units on a scale Standard Deviation 1.53
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 36: Overall Opinion (patient)	1.82 units on a scale Standard Deviation 1.65	2.23 units on a scale Standard Deviation 1.79
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Week 12: Pain not within Scar (patient)	1.00 units on a scale Standard Deviation 0.00	1.62 units on a scale Standard Deviation 1.50
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 12: Pain not within Scar (patient)	1.09 units on a scale Standard Deviation 0.58	1.67 units on a scale Standard Deviation 1.92
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. Month 36: Pain not within Scar (patient)	1.00 units on a scale Standard Deviation 0.00	1.27 units on a scale Standard Deviation 1.03

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline (pre-surgery), week 24, months 12 and 36

Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 through to visit 10 month 36.

Health Utilities Index (HUI) is a generic preference-based system for measuring comprehensive health status and health-related quality of life. Each index provides descriptive evidence on multiple dimensions of life quality.

HUI3: Comprehensive Health State, Vision, Hearing, Speech, Ambulation, Emotion, Cognition, Pain.

HUI2: Comprehensive Health State, Sensation, Mobility, Emotion, Cognition, Self Care, Pain.

Subjects completed HUI2/3 questionnaires at visit 1 (baseline), 7 (week 24), 8 (month 12) and 10 (month 36).

HUI score of 1 (maximum) describes a state of perfect health. HUI score of 0 describes a state of dead. A negative score of Comprehensive Health State describes a state worse than dead.

Outcome measures

Measure	Minimally Invasive Surgery and BA400 n=51 Participants This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).	Traditional Surgery and BA300 n=52 Participants This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Health Utilies Index (HUI-III & HUI-II) Month 36: Emotion (HUI3)	0.950 units on a scale Standard Deviation 0.073	0.906 units on a scale Standard Deviation 0.155
Health Utilies Index (HUI-III & HUI-II) Baseline: Cognition (HUI3)	0.951 units on a scale Standard Deviation 0.124	0.948 units on a scale Standard Deviation 0.144
Health Utilies Index (HUI-III & HUI-II) Week 24: Cognition (HUI3)	0.966 units on a scale Standard Deviation 0.074	0.937 units on a scale Standard Deviation 0.110
Health Utilies Index (HUI-III & HUI-II) Month 12: Cognition (HUI3)	0.944 units on a scale Standard Deviation 0.133	0.909 units on a scale Standard Deviation 0.151
Health Utilies Index (HUI-III & HUI-II) Month 36: Cognition (HUI3)	0.966 units on a scale Standard Deviation 0.074	0.935 units on a scale Standard Deviation 0.108
Health Utilies Index (HUI-III & HUI-II) Baseline: Comprehensive Health State (HUI3)	0.617 units on a scale Standard Deviation 0.272	0.620 units on a scale Standard Deviation 0.262
Health Utilies Index (HUI-III & HUI-II) Week 24: Comprehensive Health State (HUI3)	0.705 units on a scale Standard Deviation 0.173	0.671 units on a scale Standard Deviation 0.196
Health Utilies Index (HUI-III & HUI-II) Month 12: Comprehensive Health State (HUI3)	0.688 units on a scale Standard Deviation 0.206	0.650 units on a scale Standard Deviation 0.232
Health Utilies Index (HUI-III & HUI-II) Month 36: Comprehensive Health State (HUI3)	0.758 units on a scale Standard Deviation 0.147	0.639 units on a scale Standard Deviation 0.239
Health Utilies Index (HUI-III & HUI-II) Baseline: Vision (HUI3)	0.952 units on a scale Standard Deviation 0.086	0.964 units on a scale Standard Deviation 0.023
Health Utilies Index (HUI-III & HUI-II) Week 24: Vision (HUI3)	0.927 units on a scale Standard Deviation 0.169	0.935 units on a scale Standard Deviation 0.126
Health Utilies Index (HUI-III & HUI-II) Month 12: Vision (HUI3)	0.950 units on a scale Standard Deviation 0.087	0.940 units on a scale Standard Deviation 0.101
Health Utilies Index (HUI-III & HUI-II) Month 36: Vision (HUI3)	0.942 units on a scale Standard Deviation 0.095	0.929 units on a scale Standard Deviation 0.115
Health Utilies Index (HUI-III & HUI-II) Baseline: Hearing (HUI3)	0.627 units on a scale Standard Deviation 0.304	0.601 units on a scale Standard Deviation 0.304
Health Utilies Index (HUI-III & HUI-II) Week 24: Hearing (HUI3)	0.756 units on a scale Standard Deviation 0.082	0.716 units on a scale Standard Deviation 0.089
Health Utilies Index (HUI-III & HUI-II) Month 12: Hearing (HUI3)	0.726 units on a scale Standard Deviation 0.152	0.760 units on a scale Standard Deviation 0.083
Health Utilies Index (HUI-III & HUI-II) Month 36: Hearing (HUI3)	0.728 units on a scale Standard Deviation 0.172	0.683 units on a scale Standard Deviation 0.197
Health Utilies Index (HUI-III & HUI-II) Baseline: Speech (HUI3)	0.913 units on a scale Standard Deviation 0.165	0.906 units on a scale Standard Deviation 0.165
Health Utilies Index (HUI-III & HUI-II) Week 24: Speech (HUI3)	0.981 units on a scale Standard Deviation 0.073	0.989 units on a scale Standard Deviation 0.055
Health Utilies Index (HUI-III & HUI-II) Month 12: Speech (HUI3)	0.975 units on a scale Standard Deviation 0.078	0.975 units on a scale Standard Deviation 0.078
Health Utilies Index (HUI-III & HUI-II) Month 36: Speech (HUI3)	0.984 units on a scale Standard Deviation 0.062	0.956 units on a scale Standard Deviation 0.127
Health Utilies Index (HUI-III & HUI-II) Baseline: Ambulation (HUI3)	0.983 units on a scale Standard Deviation 0.061	0.958 units on a scale Standard Deviation 0.136
Health Utilies Index (HUI-III & HUI-II) Week 24: Ambulation (HUI3)	0.989 units on a scale Standard Deviation 0.043	0.966 units on a scale Standard Deviation 0.115
Health Utilies Index (HUI-III & HUI-II) Month 12: Ambulation (HUI3)	0.990 units on a scale Standard Deviation 0.053	0.949 units on a scale Standard Deviation 0.164
Health Utilies Index (HUI-III & HUI-II) Month 36: Ambulation (HUI3)	1.000 units on a scale Standard Deviation 0.000	0.924 units on a scale Standard Deviation 0.177
Health Utilies Index (HUI-III & HUI-II) Baseline: Emotion (HUI3)	0.893 units on a scale Standard Deviation 0.170	0.945 units on a scale Standard Deviation 0.108
Health Utilies Index (HUI-III & HUI-II) Week 24: Emotion (HUI3)	0.915 units on a scale Standard Deviation 0.130	0.930 units on a scale Standard Deviation 0.090
Health Utilies Index (HUI-III & HUI-II) Month 12: Emotion (HUI3)	0.911 units on a scale Standard Deviation 0.125	0.900 units on a scale Standard Deviation 0.160
Health Utilies Index (HUI-III & HUI-II) Baseline: Pain (HUI3)	0.901 units on a scale Standard Deviation 0.174	0.918 units on a scale Standard Deviation 0.164
Health Utilies Index (HUI-III & HUI-II) Week 24: Pain (HUI3)	0.933 units on a scale Standard Deviation 0.120	0.908 units on a scale Standard Deviation 0.129
Health Utilies Index (HUI-III & HUI-II) Month 12: Pain (HUI3)	0.922 units on a scale Standard Deviation 0.180	0.899 units on a scale Standard Deviation 0.215
Health Utilies Index (HUI-III & HUI-II) Month 36: Pain (HUI3)	0.977 units on a scale Standard Deviation 0.054	0.926 units on a scale Standard Deviation 0.142
Health Utilies Index (HUI-III & HUI-II) Baseline: Comprehensive Health State (HUI2)	0.799 units on a scale Standard Deviation 0.186	0.781 units on a scale Standard Deviation 0.164
Health Utilies Index (HUI-III & HUI-II) Week 24: Comprehensive Health State (HUI2)	0.853 units on a scale Standard Deviation 0.114	0.862 units on a scale Standard Deviation 0.099
Health Utilies Index (HUI-III & HUI-II) Month 12: Comprehensive Health State (HUI2)	0.853 units on a scale Standard Deviation 0.114	0.827 units on a scale Standard Deviation 0.150
Health Utilies Index (HUI-III & HUI-II) Month 36: Comprehensive Health State (HUI2)	0.896 units on a scale Standard Deviation 0.081	0.821 units on a scale Standard Deviation 0.154
Health Utilies Index (HUI-III & HUI-II) Baseline: Sensation (HUI2)	0.687 units on a scale Standard Deviation 0.264	0.666 units on a scale Standard Deviation 0.281
Health Utilies Index (HUI-III & HUI-II) Week 24: Sensation (HUI2)	0.835 units on a scale Standard Deviation 0.141	0.849 units on a scale Standard Deviation 0.066
Health Utilies Index (HUI-III & HUI-II) Month 12: Sensation (HUI2)	0.822 units on a scale Standard Deviation 0.146	0.845 units on a scale Standard Deviation 0.078
Health Utilies Index (HUI-III & HUI-II) Month 36: Sensation (HUI2)	0.828 units on a scale Standard Deviation 0.148	0.809 units on a scale Standard Deviation 0.165
Health Utilies Index (HUI-III & HUI-II) Baseline: Mobility (HUI2)	0.987 units on a scale Standard Deviation 0.058	0.972 units on a scale Standard Deviation 0.093
Health Utilies Index (HUI-III & HUI-II) Week 24: Mobility (HUI2)	0.995 units on a scale Standard Deviation 0.020	0.976 units on a scale Standard Deviation 0.084
Health Utilies Index (HUI-III & HUI-II) Month 12: Mobility (HUI2)	0.990 units on a scale Standard Deviation 0.057	0.965 units on a scale Standard Deviation 0.110
Health Utilies Index (HUI-III & HUI-II) Month 36: Mobility (HUI2)	1.000 units on a scale Standard Deviation 0.000	0.961 units on a scale Standard Deviation 0.105
Health Utilies Index (HUI-III & HUI-II) Baseline: Emotion (HUI2)	0.912 units on a scale Standard Deviation 0.162	0.929 units on a scale Standard Deviation 0.158
Health Utilies Index (HUI-III & HUI-II) Week 24: Emotion (HUI2)	0.916 units on a scale Standard Deviation 0.138	0.940 units on a scale Standard Deviation 0.098
Health Utilies Index (HUI-III & HUI-II) Month 12: Emotion (HUI2)	0.918 units on a scale Standard Deviation 0.126	0.901 units on a scale Standard Deviation 0.140
Health Utilies Index (HUI-III & HUI-II) Month 36: Emotion (HUI2)	0.959 units on a scale Standard Deviation 0.065	0.923 units on a scale Standard Deviation 0.113
Health Utilies Index (HUI-III & HUI-II) Baseline: Cognition (HUI2)	0.966 units on a scale Standard Deviation 0.072	0.960 units on a scale Standard Deviation 0.084
Health Utilies Index (HUI-III & HUI-II) Week 24: Cognition (HUI2)	0.967 units on a scale Standard Deviation 0.060	0.956 units on a scale Standard Deviation 0.066
Health Utilies Index (HUI-III & HUI-II) Month 12: Cognition (HUI2)	0.971 units on a scale Standard Deviation 0.057	0.948 units on a scale Standard Deviation 0.078
Health Utilies Index (HUI-III & HUI-II) Month 36: Cognition (HUI2)	0.968 units on a scale Standard Deviation 0.059	0.092 units on a scale Standard Deviation 0.067
Health Utilies Index (HUI-III & HUI-II) Baseline: Self Care (HUI2)	0.997 units on a scale Standard Deviation 0.022	0.994 units on a scale Standard Deviation 0.030
Health Utilies Index (HUI-III & HUI-II) Week 24: Self Care (HUI2)	0.997 units on a scale Standard Deviation 0.022	0.997 units on a scale Standard Deviation 0.022
Health Utilies Index (HUI-III & HUI-II) Month 12: Self Care (HUI2)	0.997 units on a scale Standard Deviation 0.022	0.987 units on a scale Standard Deviation 0.069
Health Utilies Index (HUI-III & HUI-II) Month 36: Self Care (HUI2)	1.000 units on a scale Standard Deviation 0.000	0.993 units on a scale Standard Deviation 0.033
Health Utilies Index (HUI-III & HUI-II) Baseline: Pain (HUI2)	0.913 units on a scale Standard Deviation 0.224	0.956 units on a scale Standard Deviation 0.099
Health Utilies Index (HUI-III & HUI-II) Week 24: Pain (HUI2)	0.957 units on a scale Standard Deviation 0.105	0.962 units on a scale Standard Deviation 0.071
Health Utilies Index (HUI-III & HUI-II) Month 12: Pain (HUI2)	0.960 units on a scale Standard Deviation 0.082	0.941 units on a scale Standard Deviation 0.146
Health Utilies Index (HUI-III & HUI-II) Month 36: Pain (HUI2)	0.990 units on a scale Standard Deviation 0.020	0.924 units on a scale Standard Deviation 0.185

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-surgery (baseline) to 24 weeks, 12 and 36 months

Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.

The Abbreviated Profile of Hearing Aid Benefit (APHAB) is a 24-item self-assessment, disability-based inventory that can be used to document the outcome of a hearing aid fitting, to compare several fittings, or to evaluate the same fitting over time. The subjects will complete the APHAB at pre-surgery, week 24, month 12 and 36.

Questions assess 'Ease of Communication', 'Background Noise', 'Reverberation', 'Aversiveness', and 'Global' in the aided and unaided situations. The aided situation was compared to the unaided situation at baseline (pre-surgery).

For each subscale, a score of 99 indicates that there is 'always' difficulty, and a score of 1 indicated that there is 'never' difficulty for that particular subscale.

Outcome measures

Measure	Minimally Invasive Surgery and BA400 n=51 Participants This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).	Traditional Surgery and BA300 n=52 Participants This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Abbreviated Profile of Hearing Aid Benefit (APHAB) Baseline: Ease of Communication (Aided)	33.9 units on a scale Standard Deviation 22.6	21.1 units on a scale Standard Deviation 17.8
Abbreviated Profile of Hearing Aid Benefit (APHAB) Baseline: Background Noise (Aided)	42.5 units on a scale Standard Deviation 16.3	35.5 units on a scale Standard Deviation 23.3
Abbreviated Profile of Hearing Aid Benefit (APHAB) Baseline: Reverberation (Aided)	48.9 units on a scale Standard Deviation 15.9	33.9 units on a scale Standard Deviation 20.3
Abbreviated Profile of Hearing Aid Benefit (APHAB) Baseline: Aversiveness (Aided)	35.5 units on a scale Standard Deviation 20.0	46.4 units on a scale Standard Deviation 22.8
Abbreviated Profile of Hearing Aid Benefit (APHAB) Baseline: Global (Aided)	40.8 units on a scale Standard Deviation 17.0	30.2 units on a scale Standard Deviation 17.8
Abbreviated Profile of Hearing Aid Benefit (APHAB) Baseline: Ease of Communication (Unaided)	45.5 units on a scale Standard Deviation 30.4	55.4 units on a scale Standard Deviation 26.8
Abbreviated Profile of Hearing Aid Benefit (APHAB) Baseline: Background Noise (Unaided)	66.6 units on a scale Standard Deviation 18.4	67.4 units on a scale Standard Deviation 19.1
Abbreviated Profile of Hearing Aid Benefit (APHAB) Baseline: Reverberation (Unaided)	58.6 units on a scale Standard Deviation 24.7	63.0 units on a scale Standard Deviation 25.4
Abbreviated Profile of Hearing Aid Benefit (APHAB) Baseline: Aversiveness (Unaided)	32.2 units on a scale Standard Deviation 24.6	25.7 units on a scale Standard Deviation 19.5
Abbreviated Profile of Hearing Aid Benefit (APHAB) Baseline: Global (Unaided)	56.9 units on a scale Standard Deviation 20.9	61.9 units on a scale Standard Deviation 20.2
Abbreviated Profile of Hearing Aid Benefit (APHAB) Baseline: Ease of Communication (Benefit)	22.1 units on a scale Standard Deviation 31.5	39.9 units on a scale Standard Deviation 26.2
Abbreviated Profile of Hearing Aid Benefit (APHAB) Baseline: Background Noise (Benefit)	29.9 units on a scale Standard Deviation 24.3	42.0 units on a scale Standard Deviation 26.5
Abbreviated Profile of Hearing Aid Benefit (APHAB) Baseline: Reverberation (Benefit)	22.7 units on a scale Standard Deviation 20.6	35.9 units on a scale Standard Deviation 29.4
Abbreviated Profile of Hearing Aid Benefit (APHAB) Baseline: Aversiveness (Benefit)	-12.3 units on a scale Standard Deviation 24.9	-23.7 units on a scale Standard Deviation 24.1
Abbreviated Profile of Hearing Aid Benefit (APHAB) Baseline: Global (Benefit)	25.3 units on a scale Standard Deviation 20.6	39.2 units on a scale Standard Deviation 21.5
Abbreviated Profile of Hearing Aid Benefit (APHAB) Week 24: Ease of Communication (Aided)	20.1 units on a scale Standard Deviation 21.0	25.7 units on a scale Standard Deviation 24.8
Abbreviated Profile of Hearing Aid Benefit (APHAB) Week 24: Background Noise (Aided)	30.5 units on a scale Standard Deviation 13.7	33.0 units on a scale Standard Deviation 20.7
Abbreviated Profile of Hearing Aid Benefit (APHAB) Week 24: Reverberation (Aided)	29.4 units on a scale Standard Deviation 12.4	34.9 units on a scale Standard Deviation 19.8
Abbreviated Profile of Hearing Aid Benefit (APHAB) Week 24: Aversiveness (Aided)	42.9 units on a scale Standard Deviation 21.9	44.7 units on a scale Standard Deviation 26.2
Abbreviated Profile of Hearing Aid Benefit (APHAB) Week 24: Global (Aided)	26.7 units on a scale Standard Deviation 13.0	31.1 units on a scale Standard Deviation 18.8
Abbreviated Profile of Hearing Aid Benefit (APHAB) Week 24: Ease of Communication (Unaided)	44.2 units on a scale Standard Deviation 26.6	52.8 units on a scale Standard Deviation 28.8
Abbreviated Profile of Hearing Aid Benefit (APHAB) Week 24: Background Noise (Unaided)	66.5 units on a scale Standard Deviation 17.8	65.3 units on a scale Standard Deviation 19.3
Abbreviated Profile of Hearing Aid Benefit (APHAB) Week 24: Reverberation (Unaided)	57.1 units on a scale Standard Deviation 21.4	63.2 units on a scale Standard Deviation 19.6
Abbreviated Profile of Hearing Aid Benefit (APHAB) Week 24: Aversiveness (Unaided)	29.6 units on a scale Standard Deviation 22.3	18.3 units on a scale Standard Deviation 17.5
Abbreviated Profile of Hearing Aid Benefit (APHAB) Week 24: Global (Unaided)	55.9 units on a scale Standard Deviation 18.6	60.4 units on a scale Standard Deviation 19.3
Abbreviated Profile of Hearing Aid Benefit (APHAB) Week 24: Ease of Communication (Benefit)	29.3 units on a scale Standard Deviation 30.6	30.6 units on a scale Standard Deviation 36.5
Abbreviated Profile of Hearing Aid Benefit (APHAB) Week 24: Background Noise (Benefit)	37.8 units on a scale Standard Deviation 22.8	37.6 units on a scale Standard Deviation 22.8
Abbreviated Profile of Hearing Aid Benefit (APHAB) Week 24: Reverberation (Benefit)	31.5 units on a scale Standard Deviation 24.1	32.4 units on a scale Standard Deviation 32.7
Abbreviated Profile of Hearing Aid Benefit (APHAB) Week 24: Aversiveness (Benefit)	-10.7 units on a scale Standard Deviation 31.2	-20.4 units on a scale Standard Deviation 25.3
Abbreviated Profile of Hearing Aid Benefit (APHAB) Week 24: Global (Benefit)	32.9 units on a scale Standard Deviation 21.0	33.5 units on a scale Standard Deviation 26.5
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 12: Ease of Communication (Aided)	17.5 units on a scale Standard Deviation 18.0	19.7 units on a scale Standard Deviation 18.7
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 12: Background Noise (Aided)	29.9 units on a scale Standard Deviation 14.8	32.3 units on a scale Standard Deviation 14.1
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 12: Reverberation (Aided)	31.8 units on a scale Standard Deviation 16.5	30.9 units on a scale Standard Deviation 14.0
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 12: Aversiveness (Aided)	39.3 units on a scale Standard Deviation 23.0	37.4 units on a scale Standard Deviation 28.8
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 12: Global (Aided)	26.7 units on a scale Standard Deviation 13.5	27.6 units on a scale Standard Deviation 12.2
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 12: Ease of Communication (Unaided)	41.8 units on a scale Standard Deviation 27.5	52.0 units on a scale Standard Deviation 28.5
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month12: Background Noise (Unaided)	65.0 units on a scale Standard Deviation 20.8	64.1 units on a scale Standard Deviation 19.7
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 12: Reverberation (Unaided)	53.4 units on a scale Standard Deviation 20.0	60.9 units on a scale Standard Deviation 20.0
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month12: Aversiveness (Unaided)	30.2 units on a scale Standard Deviation 21.8	23.5 units on a scale Standard Deviation 20.7
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 12: Global (Unaided)	53.7 units on a scale Standard Deviation 20.4	58.7 units on a scale Standard Deviation 19.9
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 12: Ease of Communication (Benefit)	41.8 units on a scale Standard Deviation 27.5	52.0 units on a scale Standard Deviation 28.5
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 12: Background Noise (Benefit)	65.0 units on a scale Standard Deviation 20.8	64.1 units on a scale Standard Deviation 19.7
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 12: Reverberation (Benefit)	53.4 units on a scale Standard Deviation 20.0	60.9 units on a scale Standard Deviation 20.0
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 12: Aversiveness (Benefit)	30.2 units on a scale Standard Deviation 21.8	23.5 units on a scale Standard Deviation 20.7
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 12: Global (Benefit)	53.7 units on a scale Standard Deviation 20.4	58.7 units on a scale Standard Deviation 19.9
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 36: Ease of Communication (Aided)	19.3 units on a scale Standard Deviation 21.3	18.1 units on a scale Standard Deviation 20.1
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 36: Background Noise (Aided)	33.5 units on a scale Standard Deviation 16.6	35.7 units on a scale Standard Deviation 17.2
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 36: Reverberation (Aided)	32.7 units on a scale Standard Deviation 18.2	30.6 units on a scale Standard Deviation 13.9
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 36: Aversiveness (Aided)	36.2 units on a scale Standard Deviation 24.8	36.9 units on a scale Standard Deviation 25.9
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 36: Global (Aided)	28.5 units on a scale Standard Deviation 15.8	28.1 units on a scale Standard Deviation 14.2
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 36: Ease of Communication (Unaided)	45.9 units on a scale Standard Deviation 23.6	50.0 units on a scale Standard Deviation 23.8
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 36: Background Noise (Unaided)	66.5 units on a scale Standard Deviation 19.4	62.9 units on a scale Standard Deviation 18.3
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 36: Reverberation (Unaided)	60.4 units on a scale Standard Deviation 21.1	56.6 units on a scale Standard Deviation 19.6
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 36: Aversiveness (Unaided)	38.5 units on a scale Standard Deviation 23.0	26.1 units on a scale Standard Deviation 20.8
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 36: Global (Unaided)	57.7 units on a scale Standard Deviation 18.1	56.5 units on a scale Standard Deviation 17.3
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 36: Ease of Communication (Benefit)	27.6 units on a scale Standard Deviation 36.6	38.5 units on a scale Standard Deviation 28.0
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 36: Background Noise (Benefit)	32.8 units on a scale Standard Deviation 21.1	33.9 units on a scale Standard Deviation 22.2
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 36: Reverberation (Benefit)	27.8 units on a scale Standard Deviation 26.8	34.2 units on a scale Standard Deviation 30.6
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 36: Aversiveness (Benefit)	-2.22 units on a scale Standard Deviation 31.71	-9.19 units on a scale Standard Deviation 32.95
Abbreviated Profile of Hearing Aid Benefit (APHAB) Month 36: Global (Benefit)	29.4 units on a scale Standard Deviation 23.1	35.5 units on a scale Standard Deviation 22.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 6, 12, 24, Months 12, 24, 36

Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.

Use of the sound processor can be seen as a reflection of patient satisfaction and treatment compliance. Patients were asked to record how many hours per week they used the sound processor after Baha loading at week 3.

Outcome measures

Measure	Minimally Invasive Surgery and BA400 n=51 Participants This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).	Traditional Surgery and BA300 n=52 Participants This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Use of Sound Processor Week 24: No Sound Processor Usage (Patients)	1 Hours of use per week Standard Deviation 2.1	0 Hours of use per week Standard Deviation 0
Use of Sound Processor Week 6: No Sound Processor Usage (Patients)	0 Hours of use per week Standard Deviation 0	0 Hours of use per week Standard Deviation 0
Use of Sound Processor Week 6: Sound Processor Usage (hours/week)	80.4 Hours of use per week Standard Deviation 30.1	83.6 Hours of use per week Standard Deviation 27.7
Use of Sound Processor Week 12: No Sound Processor Usage (Patients)	2 Hours of use per week Standard Deviation 4.8	1 Hours of use per week Standard Deviation 2.1
Use of Sound Processor Week 12: Sound Processor Usage (hours/week)	75.2 Hours of use per week Standard Deviation 33.0	77.9 Hours of use per week Standard Deviation 29.7
Use of Sound Processor Week 24: Sound Processor Usage (hours/week)	74.6 Hours of use per week Standard Deviation 34.1	78.0 Hours of use per week Standard Deviation 30.6
Use of Sound Processor Month 12: No Sound Processor Usage (Patients)	2 Hours of use per week Standard Deviation 4.2	1 Hours of use per week Standard Deviation 2.1
Use of Sound Processor Month 12: Sound Processor Usage (hours/week)	73.5 Hours of use per week Standard Deviation 35.1	80.1 Hours of use per week Standard Deviation 29.4
Use of Sound Processor Month 24: No Sound Processor Usage (Patients)	2 Hours of use per week Standard Deviation 4.3	1 Hours of use per week Standard Deviation 2.3
Use of Sound Processor Month 24: Sound Processor Usage (hours/week)	68.3 Hours of use per week Standard Deviation 36.7	72.1 Hours of use per week Standard Deviation 36.6
Use of Sound Processor Month 36: No Sound Processor Usage (Patients)	0 Hours of use per week Standard Deviation 0	1 Hours of use per week Standard Deviation 2.4
Use of Sound Processor Month 36: Sound Processor Usage (hours/week)	74.3 Hours of use per week Standard Deviation 32.2	77.7 Hours of use per week Standard Deviation 32.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Surgery, Day 10, Weeks 3, 6, 12, 24, Months 12, 24, 36

Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.

ISQ is a well-established method to measure stability of osseointegrated implants and has been used for several years both for bone conduction implants and for dental implants. Measurements were performed using resonance frequency analysis at the abutment level. The highest and lowest ISQ value out of two perpendicular measurements obtained at each time point was recorded, ISQ High and ISQ Low. The ISQ values ranges from 1 to 100.

Overall, the length of test abutments (BA400) were longer than control abutments (BA300) and there is an inverse correlation between abutment length and stability. A direct comparison between the groups is not relevant.

Implant Stability Quotient (ISQ) was recorded at surgery as a baseline value and at visit 2-10.

Outcome measures

Measure	Minimally Invasive Surgery and BA400 n=51 Participants This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).	Traditional Surgery and BA300 n=52 Participants This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Implant Stability (ISQ) Surgery: ISQ (High)	55.4 Implant Stability Quotient Standard Deviation 6.6	66.2 Implant Stability Quotient Standard Deviation 4.1
Implant Stability (ISQ) Surgery: ISQ (Low)	53.2 Implant Stability Quotient Standard Deviation 6.7	64.1 Implant Stability Quotient Standard Deviation 4.8
Implant Stability (ISQ) Day 10: ISQ (High)	54.9 Implant Stability Quotient Standard Deviation 8.7	63.4 Implant Stability Quotient Standard Deviation 9.3
Implant Stability (ISQ) Day 10: ISQ (Low)	52.6 Implant Stability Quotient Standard Deviation 9.8	61.3 Implant Stability Quotient Standard Deviation 9.7
Implant Stability (ISQ) Week 3: ISQ (High)	54.6 Implant Stability Quotient Standard Deviation 9.0	65.2 Implant Stability Quotient Standard Deviation 5.2
Implant Stability (ISQ) Week 3: ISQ (Low)	52.2 Implant Stability Quotient Standard Deviation 9.9	63.3 Implant Stability Quotient Standard Deviation 5.8
Implant Stability (ISQ) Week 6: ISQ (High)	56.6 Implant Stability Quotient Standard Deviation 7.3	64.6 Implant Stability Quotient Standard Deviation 6.9
Implant Stability (ISQ) Week 6: ISQ (Low)	53.3 Implant Stability Quotient Standard Deviation 9.3	62.4 Implant Stability Quotient Standard Deviation 7.9
Implant Stability (ISQ) Week 12: ISQ (High)	58.0 Implant Stability Quotient Standard Deviation 6.3	66.1 Implant Stability Quotient Standard Deviation 4.9
Implant Stability (ISQ) Week 12: ISQ (Low)	55.6 Implant Stability Quotient Standard Deviation 6.7	63.8 Implant Stability Quotient Standard Deviation 6.0
Implant Stability (ISQ) Week 24: ISQ (High)	59.7 Implant Stability Quotient Standard Deviation 5.4	66.8 Implant Stability Quotient Standard Deviation 4.3
Implant Stability (ISQ) Week 24: ISQ (Low)	57.5 Implant Stability Quotient Standard Deviation 5.7	64.4 Implant Stability Quotient Standard Deviation 5.3
Implant Stability (ISQ) Month 12: ISQ (High)	59.6 Implant Stability Quotient Standard Deviation 5.0	67.6 Implant Stability Quotient Standard Deviation 4.0
Implant Stability (ISQ) Month 12: ISQ (Low)	58.0 Implant Stability Quotient Standard Deviation 4.8	65.5 Implant Stability Quotient Standard Deviation 4.7
Implant Stability (ISQ) Month 24: ISQ (High)	60.4 Implant Stability Quotient Standard Deviation 6.1	66.8 Implant Stability Quotient Standard Deviation 5.5
Implant Stability (ISQ) Month 24: ISQ (Low)	59.0 Implant Stability Quotient Standard Deviation 6.2	66.2 Implant Stability Quotient Standard Deviation 4.3
Implant Stability (ISQ) Month 36: ISQ (High)	59.6 Implant Stability Quotient Standard Deviation 6.0	67.0 Implant Stability Quotient Standard Deviation 5.3
Implant Stability (ISQ) Month 36: ISQ (Low)	58.2 Implant Stability Quotient Standard Deviation 5.8	62.5 Implant Stability Quotient Standard Deviation 5.5

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, Weeks 3, 12, Months 12, 24 and 36

Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.

Nicotine use and smoking habits were recorded for patients.

1. Does not smoke

2. Less than 10 cigarettes/day (Low consumption)

3. Between 11 and 20 cigarettes/day (Medium consumption)

4. Between 21 and 40 cigarettes/day (High consumption)

5. More than 40 cigarettes/day (Very high consumption)

In Sweden a large proportion of adults use another form of tobacco, wet snuff. In Sweden the patients were asked if they used wet snuff.

Outcome measures

Measure	Minimally Invasive Surgery and BA400 n=51 Participants This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).	Traditional Surgery and BA300 n=52 Participants This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Smoking Habits by Visit Month 36 Smoking · Yes, More than 40 cigarettes/day	0 Participants	0 Participants
Smoking Habits by Visit Baseline Smoking · No Smoking	37 Participants	38 Participants
Smoking Habits by Visit Baseline Smoking · Yes, Less than 10 cigarettes/day	5 Participants	3 Participants
Smoking Habits by Visit Baseline Smoking · Yes, Between 11-20 cigarettes/day	8 Participants	8 Participants
Smoking Habits by Visit Baseline Smoking · Yes, Between 21-40 cigarettes/day	1 Participants	2 Participants
Smoking Habits by Visit Baseline Smoking · Yes, More than 40 cigarettes/day	0 Participants	0 Participants
Smoking Habits by Visit Baseline Smoking · Wet Snuff	0 Participants	0 Participants
Smoking Habits by Visit Baseline Smoking · Not answered	0 Participants	1 Participants
Smoking Habits by Visit Week 3 Smoking · No Smoking	36 Participants	39 Participants
Smoking Habits by Visit Week 3 Smoking · Yes, Less than 10 cigarettes/day	5 Participants	4 Participants
Smoking Habits by Visit Week 3 Smoking · Yes, Between 11-20 cigarettes/day	7 Participants	7 Participants
Smoking Habits by Visit Week 3 Smoking · Yes, Between 21-40 cigarettes/day	1 Participants	1 Participants
Smoking Habits by Visit Week 3 Smoking · Yes, More than 40 cigarettes/day	0 Participants	0 Participants
Smoking Habits by Visit Week 3 Smoking · Wet Snuff	1 Participants	0 Participants
Smoking Habits by Visit Week 3 Smoking · Not answered	0 Participants	1 Participants
Smoking Habits by Visit Week 12 Smoking · No Smoking	32 Participants	38 Participants
Smoking Habits by Visit Week 12 Smoking · Yes, Less than 10 cigarettes/day	8 Participants	4 Participants
Smoking Habits by Visit Week 12 Smoking · Yes, Between 11-20 cigarettes/day	4 Participants	6 Participants
Smoking Habits by Visit Week 12 Smoking · Yes, Between 21-40 cigarettes/day	2 Participants	2 Participants
Smoking Habits by Visit Week 12 Smoking · Yes, More than 40 cigarettes/day	0 Participants	0 Participants
Smoking Habits by Visit Week 12 Smoking · Wet Snuff	1 Participants	0 Participants
Smoking Habits by Visit Week 12 Smoking · Not answered	0 Participants	0 Participants
Smoking Habits by Visit Month 12 Smoking · No Smoking	35 Participants	33 Participants
Smoking Habits by Visit Month 12 Smoking · Yes, Less than 10 cigarettes/day	8 Participants	4 Participants
Smoking Habits by Visit Month 12 Smoking · Yes, Between 11-20 cigarettes/day	2 Participants	8 Participants
Smoking Habits by Visit Month 12 Smoking · Yes, Between 21-40 cigarettes/day	2 Participants	3 Participants
Smoking Habits by Visit Month 12 Smoking · Yes, More than 40 cigarettes/day	0 Participants	0 Participants
Smoking Habits by Visit Month 12 Smoking · Wet Snuff	1 Participants	0 Participants
Smoking Habits by Visit Month 12 Smoking · Not answered	0 Participants	0 Participants
Smoking Habits by Visit Month 24 Smoking · No Smoking	34 Participants	31 Participants
Smoking Habits by Visit Month 24 Smoking · Yes, Less than 10 cigarettes/day	7 Participants	6 Participants
Smoking Habits by Visit Month 24 Smoking · Yes, Between 11-20 cigarettes/day	3 Participants	6 Participants
Smoking Habits by Visit Month 24 Smoking · Yes, Between 21-40 cigarettes/day	1 Participants	3 Participants
Smoking Habits by Visit Month 24 Smoking · Yes, More than 40 cigarettes/day	0 Participants	0 Participants
Smoking Habits by Visit Month 24 Smoking · Wet Snuff	0 Participants	0 Participants
Smoking Habits by Visit Month 24 Smoking · Not answered	1 Participants	0 Participants
Smoking Habits by Visit Month 36 Smoking · No Smoking	34 Participants	30 Participants
Smoking Habits by Visit Month 36 Smoking · Yes, Less than 10 cigarettes/day	6 Participants	3 Participants
Smoking Habits by Visit Month 36 Smoking · Yes, Between 11-20 cigarettes/day	4 Participants	6 Participants
Smoking Habits by Visit Month 36 Smoking · Yes, Between 21-40 cigarettes/day	1 Participants	2 Participants
Smoking Habits by Visit Month 36 Smoking · Wet Snuff	0 Participants	0 Participants
Smoking Habits by Visit Month 36 Smoking · Not answered	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: from surgery through to 36 months

Population: The Safety Population includes all patients who had the surgical treatment.

'Loss of Implant' refers to the loss of the implant for reasons including failure of implant to osseointegrate, or an implant that was loose form surgery. It does not include elected removal of the device.

Outcome measures

Measure	Minimally Invasive Surgery and BA400 n=52 Participants This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).	Traditional Surgery and BA300 n=52 Participants This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Loss of Implant	1 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: from surgery through to 36 months

Population: The Safety Population includes all patients who had the surgical treatment.

Count of subjects who had their abutment removed for reasons of health and safety, such as infection, inflammation or pain.

Outcome measures

Measure	Minimally Invasive Surgery and BA400 n=52 Participants This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).	Traditional Surgery and BA300 n=52 Participants This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Removal of Abutment	2 Participants	2 Participants

Adverse Events

Minimally Invasive Surgery and BA400

Serious events: 7 serious events

Other events: 35 other events

Deaths: 1 deaths

Traditional Surgery and BA300

Serious events: 10 serious events

Other events: 39 other events

Deaths: 1 deaths

Serious adverse events

Measure	Minimally Invasive Surgery and BA400 n=52 participants at risk This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)	Traditional Surgery and BA300 n=52 participants at risk This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Cardiac disorders Cardiac Arrhythmia	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	1.9% 1/52 • Number of events 2 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Ear and labyrinth disorders Inner ear disorder	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
General disorders Implant site pain	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	3.8% 2/52 • Number of events 2 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
General disorders Device Expulsion	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
General disorders Accidental Death	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Infections and infestations Pneumonia	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Infections and infestations Infected skin ulcer	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Injury, poisoning and procedural complications Road traffic accident	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Pregnancy, puerperium and perinatal conditions Ectopic Pregnancy	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Psychiatric disorders Depression	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Surgical and medical procedures Medical device removal	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Surgical and medical procedures Ear operation	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Surgical and medical procedures Surgery	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Surgical and medical procedures Mastoidectomy	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Surgical and medical procedures Cardiac pacemaker insertion	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Surgical and medical procedures Aortic valve replacement	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
General disorders Death	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
General disorders Device failure	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
General disorders Pain	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Injury, poisoning and procedural complications Wound secretion	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.

Other adverse events

Measure	Minimally Invasive Surgery and BA400 n=52 participants at risk This arm involves no soft tissue reduction around the BA400 implant. Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)	Traditional Surgery and BA300 n=52 participants at risk This arm involves traditional soft tissue reduction around the BA300 implant Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Ear and labyrinth disorders Tinnitus	5.8% 3/52 • Number of events 3 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Gastrointestinal disorders Implant site pain	3.8% 2/52 • Number of events 3 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	9.6% 5/52 • Number of events 6 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
General disorders Implant site scar	3.8% 2/52 • Number of events 2 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	7.7% 4/52 • Number of events 4 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
General disorders Installation site erythema	48.1% 25/52 • Number of events 57 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	34.6% 18/52 • Number of events 29 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Infections and infestations Ear Infection	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	7.7% 4/52 • Number of events 5 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Infections and infestations Nasopharyngitis	7.7% 4/52 • Number of events 4 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	7.7% 4/52 • Number of events 4 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Infections and infestations Otitis media	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	7.7% 4/52 • Number of events 4 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Injury, poisoning and procedural complications Wound dehiscence	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	11.5% 6/52 • Number of events 9 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Injury, poisoning and procedural complications Wound secretions	36.5% 19/52 • Number of events 34 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	23.1% 12/52 • Number of events 16 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Nervous system disorders Dizzy postural	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	5.8% 3/52 • Number of events 3 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Nervous system disorders Headache	0.00% 0/52 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	5.8% 3/52 • Number of events 4 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Skin and subcutaneous tissue disorders Excessive granulation tissue	15.4% 8/52 • Number of events 12 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	5.8% 3/52 • Number of events 3 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Skin and subcutaneous tissue disorders Excessive skin	3.8% 2/52 • Number of events 2 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	5.8% 3/52 • Number of events 3 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.
Skin and subcutaneous tissue disorders Skin swelling	5.8% 3/52 • Number of events 5 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.	1.9% 1/52 • Number of events 1 • 3 years One subject was randomised to control group (BA300) but received the test abutment. The subject was considered as an 'Early withdrawal' after surgery. The Number of Participants at Risk for All-Cause Mortality is therefore greater than the number Started in the Participant Flow, though the subject was still included in the safety population.

Additional Information

Professor Robert Stokroos

Ear Nose Throat, University Medical Center Utrecht, Utrecht

Phone: 0031 8875 56644

Email: R.J.Stokroos@umcutrecht.nl

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60