Trial Outcomes & Findings for Ponto Implantation Using a Minimally Invasive Surgical Technique (NCT NCT04606823)
NCT ID: NCT04606823
Last Updated: 2026-01-29
Results Overview
The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin overgrowth and pain preventing use of the sound processor. For a positive outcome of the primary endpoint (reliable anchorage), the implant should be in place and stable without any adverse skin reactions, skin overgrowth or pain preventing usage of the sound processor.
COMPLETED
NA
52 participants
3 months after implant surgery
2026-01-29
Participant Flow
Participant milestones
| Measure |
Single-arm
In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
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|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Single-arm
In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
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|---|---|
|
Overall Study
Delayed surgery, withdrawn
|
1
|
Baseline Characteristics
Ponto Implantation Using a Minimally Invasive Surgical Technique
Baseline characteristics by cohort
| Measure |
Single-arm
n=52 Implants
In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=35 Participants
|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 15.6 • n=35 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
46 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=35 Participants
|
|
Region of Enrollment
Sweden
|
6 participants
n=35 Participants
|
|
Region of Enrollment
Netherlands
|
14 participants
n=35 Participants
|
|
Region of Enrollment
Denmark
|
6 participants
n=35 Participants
|
|
Region of Enrollment
United Kingdom
|
25 participants
n=35 Participants
|
|
BMI
|
27.0 kg/m2
STANDARD_DEVIATION 4.2 • n=35 Participants
|
|
Smoking
Current smoker
|
8 Participants
n=35 Participants
|
|
Smoking
History of smoking
|
21 Participants
n=35 Participants
|
|
Smoking
No smoking
|
22 Participants
n=35 Participants
|
|
Hearing loss indication
Conductive hearing loss
|
15 Participants
n=35 Participants
|
|
Hearing loss indication
Mixed hearing loss
|
25 Participants
n=35 Participants
|
|
Hearing loss indication
Sensorineural hearing loss
|
3 Participants
n=35 Participants
|
|
Hearing loss indication
Single sided deafness
|
8 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 3 months after implant surgeryThe variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin overgrowth and pain preventing use of the sound processor. For a positive outcome of the primary endpoint (reliable anchorage), the implant should be in place and stable without any adverse skin reactions, skin overgrowth or pain preventing usage of the sound processor.
Outcome measures
| Measure |
Single-arm
n=52 Implants
In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
|
|---|---|
|
Number of Implants With Reliable Anchorage for a Sound Processor
|
49 Implants
|
SECONDARY outcome
Timeframe: 12 months after implant surgeryThe variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin overgrowth and pain preventing use of the sound processor. For a positive outcome (reliable anchorage), the implant should be in place and stable without any adverse skin reactions, skin overgrowth or pain preventing usage of the sound processor.
Outcome measures
| Measure |
Single-arm
n=52 Implants
In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
|
|---|---|
|
Number of Implants With Reliable Anchorage for a Sound Processor
|
46 Implants
|
SECONDARY outcome
Timeframe: 12 months after implant surgeryImplant survival will be assessed by the investigator by means of a Yes/No question: Implant in place \[Yes/No\]
Outcome measures
| Measure |
Single-arm
n=52 Implants
In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
|
|---|---|
|
Implant Survival
|
48 Implants
|
SECONDARY outcome
Timeframe: 12 months after implant surgeryClinical assessment of implant stability by the investigator by means of a Yes/No question: Implant stable \[Yes/No\]
Outcome measures
| Measure |
Single-arm
n=52 Implants
In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
|
|---|---|
|
Implant Stability
|
48 Implants
|
SECONDARY outcome
Timeframe: 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visitsPopulation: The analysis is based on number of implants (one participant had two implants). The total number of visits varies between different time points due to missed visits, and all available data is reported. Holgers scores were reported in a total of 22 unplanned visits.
Distribution of Holgers score ratings assigned by investigator across all study visits. The Holgers score is used to grade skin reactions around the skin-penetrating abutment on a scale from 0 to 4, where 0 indicates a reaction-free area whereas 4 indicates a severe infection often requiring removal of the implant. The results are presented based on Holgers score distribution across all study visits, as well as separate for each study visit and for unplanned visits.
Outcome measures
| Measure |
Single-arm
n=265 Visits
In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
|
|---|---|
|
Holgers Score Distribution
All study visits : Holgers 0
|
205 Visits
|
|
Holgers Score Distribution
All study visits : Holgers 1
|
53 Visits
|
|
Holgers Score Distribution
All study visits : Holgers 2
|
6 Visits
|
|
Holgers Score Distribution
All study visits : Holgers 3
|
1 Visits
|
|
Holgers Score Distribution
All study visits : Holgers 4
|
0 Visits
|
|
Holgers Score Distribution
9 days : Holgers 0
|
35 Visits
|
|
Holgers Score Distribution
9 days : Holgers 1
|
17 Visits
|
|
Holgers Score Distribution
9 days : Holgers 2
|
0 Visits
|
|
Holgers Score Distribution
9 days : Holgers 3
|
0 Visits
|
|
Holgers Score Distribution
9 days : Holgers 4
|
0 Visits
|
|
Holgers Score Distribution
5 weeks : Holgers 0
|
40 Visits
|
|
Holgers Score Distribution
5 weeks : Holgers 1
|
8 Visits
|
|
Holgers Score Distribution
5 weeks : Holgers 2
|
1 Visits
|
|
Holgers Score Distribution
5 weeks : Holgers 3
|
0 Visits
|
|
Holgers Score Distribution
5 weeks : Holgers 4
|
0 Visits
|
|
Holgers Score Distribution
3 months : Holgers 0
|
36 Visits
|
|
Holgers Score Distribution
3 months : Holgers 1
|
12 Visits
|
|
Holgers Score Distribution
3 months : Holgers 2
|
1 Visits
|
|
Holgers Score Distribution
3 months : Holgers 3
|
0 Visits
|
|
Holgers Score Distribution
3 months : Holgers 4
|
0 Visits
|
|
Holgers Score Distribution
6 months : Holgers 0
|
38 Visits
|
|
Holgers Score Distribution
6 months : Holgers 1
|
6 Visits
|
|
Holgers Score Distribution
6 months : Holgers 2
|
1 Visits
|
|
Holgers Score Distribution
6 months : Holgers 3
|
0 Visits
|
|
Holgers Score Distribution
6 months : Holgers 4
|
0 Visits
|
|
Holgers Score Distribution
12 months : Holgers 0
|
43 Visits
|
|
Holgers Score Distribution
12 months : Holgers 1
|
4 Visits
|
|
Holgers Score Distribution
12 months : Holgers 2
|
1 Visits
|
|
Holgers Score Distribution
12 months : Holgers 3
|
0 Visits
|
|
Holgers Score Distribution
12 months : Holgers 4
|
0 Visits
|
|
Holgers Score Distribution
Unplanned visits : Holgers 0
|
13 Visits
|
|
Holgers Score Distribution
Unplanned visits : Holgers 1
|
6 Visits
|
|
Holgers Score Distribution
Unplanned visits : Holgers 2
|
2 Visits
|
|
Holgers Score Distribution
Unplanned visits : Holgers 3
|
1 Visits
|
|
Holgers Score Distribution
Unplanned visits : Holgers 4
|
0 Visits
|
SECONDARY outcome
Timeframe: 12 months after implant surgeryMax Holgers score rating per patient across study visits. The Holgers score is used to grade skin reactions around the skin-penetrating abutment on a scale from 0 to 4, where 0 indicates a reaction-free area whereas 4 indicates a severe infection often requiring removal of the implant.
Outcome measures
| Measure |
Single-arm
n=52 Implants
In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
|
|---|---|
|
Max Holgers Score
Holgers 2
|
5 Implants
|
|
Max Holgers Score
Holgers 3
|
1 Implants
|
|
Max Holgers Score
Holgers 4
|
0 Implants
|
|
Max Holgers Score
Holgers 0
|
17 Implants
|
|
Max Holgers Score
Holgers 1
|
29 Implants
|
SECONDARY outcome
Timeframe: 12 months after implant surgeryPopulation: The analysis is based on number of implants (one participant had two implants). The total number of visits varies between different time points due to missed visits, and all available data is reported. Holgers scores were reported in a total of 22 unplanned visits.
Mild/Adverse skin reaction per patient across study visits, where adverse skin reaction is defined as Holgers ≥ 2 on at least one follow-up visit. The Holgers score is used to grade skin reactions around the skin-penetrating abutment on a scale from 0 to 4, where 0 indicates a reaction-free area whereas 4 indicates a severe infection often requiring removal of the implant.
Outcome measures
| Measure |
Single-arm
n=265 Visits
In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
|
|---|---|
|
Mild/Adverse Skin Reaction
No or minor skin reaction (Holgers 0-1)
|
258 Visits
|
|
Mild/Adverse Skin Reaction
Adverse skin reaction (Holgers 2-4)
|
7 Visits
|
SECONDARY outcome
Timeframe: 9 days, 5 weeks, 3-, 6- and 12 months after implant surgery, and unplanned visitsPopulation: The analysis is based on number of implants (one participant had two implants). The total number of visits varies between different time points due to missed visits, and all available data is reported. IPS scores were reported in a total of 22 unplanned visits. For one unplanned visit, only I- and P-scores were reported.
Distribution of IPS scores assigned by investigator across all study visits. The IPS scale is used to assess soft tissue status including inflammation (I), pain (P), and skin height (S) for a skin-penetrating implant, with scores ranging from 0 to 4 for the I-scale, and from 0 to 2 for the P- and S-scales. The IPS score is presented as \[Ix Px Sx\] with x being the individual score for each parameter. A higher score reflects a more severe complication. The results are presented based on IPS score distribution across all study visits, as well as separate for each study visit and unplanned visits.
Outcome measures
| Measure |
Single-arm
n=265 Visits
In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
|
|---|---|
|
IPS (Inflammation, Pain, Skin Height) Scores
All study visits : I-score 4
|
0 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
All study visits : I-score 0
|
195 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
All study visits : I-score 1
|
55 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
All study visits : I-score 2
|
13 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
All study visits : I-score 3
|
2 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
All study visits : P-score 0
|
209 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
All study visits : P-score 1
|
38 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
All study visits : P-score 2
|
18 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
All study visits : S-score 0
|
243 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
All study visits : S-score 1
|
21 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
All study visits : S-score 2
|
0 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
9 days : I-score 0
|
29 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
9 days : I-score 1
|
18 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
9 days : I-score 2
|
5 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
9 days : I-score 3
|
0 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
9 days : I-score 4
|
0 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
9 days : P-score 0
|
31 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
9 days : P-score 1
|
14 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
9 days : P-score 2
|
7 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
9 days : S-score 0
|
51 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
9 days : S-score 1
|
1 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
9 days : S-score 2
|
0 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
5 weeks : I-score 0
|
39 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
5 weeks : I-score 1
|
8 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
5 weeks : I-score 2
|
1 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
5 weeks : I-score 3
|
1 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
5 weeks : I-score 4
|
0 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
5 weeks : P-score 0
|
39 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
5 weeks : P-score 1
|
10 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
5 weeks : P-score 2
|
0 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
5 weeks : S-score 0
|
45 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
5 weeks : S-score 1
|
4 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
5 weeks : S-score 2
|
0 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
3 months : I-score 0
|
37 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
3 months : I-score 1
|
10 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
3 months : I-score 2
|
2 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
3 months : I-score 3
|
0 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
3 months : I-score 4
|
0 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
3 months : P-score 0
|
38 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
3 months : P-score 1
|
7 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
3 months : P-score 2
|
4 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
3 months : S-score 0
|
42 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
3 months : S-score 1
|
7 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
3 months : S-score 2
|
0 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
6 months : I-score 0
|
37 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
6 months : I-score 1
|
6 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
6 months : I-score 2
|
1 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
6 months : I-score 3
|
1 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
6 months : I-score 4
|
0 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
6 months : P-score 0
|
41 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
6 months : P-score 1
|
1 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
6 months : P-score 2
|
3 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
6 months : S-score 0
|
41 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
6 months : S-score 1
|
4 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
6 months : S-score 2
|
0 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
12 months : I-score 0
|
41 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
12 months : I-score 1
|
5 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
12 months : I-score 2
|
2 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
12 months : I-score 3
|
0 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
12 months : I-score 4
|
0 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
12 months : P-score 0
|
40 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
12 months : P-score 1
|
5 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
12 months : P-score 2
|
3 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
12 months : S-score 0
|
45 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
12 months : S-score 1
|
3 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
12 months : S-score 2
|
0 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
Unplanned visits : I-score 0
|
12 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
Unplanned visits : I-score 1
|
8 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
Unplanned visits : I-score 2
|
2 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
Unplanned visits : I-score 3
|
0 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
Unplanned visits : I-score 4
|
0 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
Unplanned visits : P-score 0
|
20 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
Unplanned visits : P-score 1
|
1 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
Unplanned visits : P-score 2
|
1 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
Unplanned visits : S-score 0
|
19 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
Unplanned visits : S-score 1
|
2 Visits
|
|
IPS (Inflammation, Pain, Skin Height) Scores
Unplanned visits : S-score 2
|
0 Visits
|
SECONDARY outcome
Timeframe: 9 days, 5 weeks and 3 months after implant surgery, and unplanned visitsPopulation: Wound healing status was reported in a total of 17 unplanned visits.
Investigator assessment of wound being completely healed by means of a Yes/No question. The results are presented for each study visit and for unplanned visits.
Outcome measures
| Measure |
Single-arm
n=167 Visits
In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
|
|---|---|
|
Wound Healing
9 days : Yes
|
37 Visits
|
|
Wound Healing
9 days : No
|
15 Visits
|
|
Wound Healing
5 weeks : Yes
|
45 Visits
|
|
Wound Healing
5 weeks : No
|
4 Visits
|
|
Wound Healing
3 months : Yes
|
48 Visits
|
|
Wound Healing
3 months : No
|
1 Visits
|
|
Wound Healing
Unplanned visits : Yes
|
15 Visits
|
|
Wound Healing
Unplanned visits : No
|
2 Visits
|
SECONDARY outcome
Timeframe: 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visitsPopulation: The analysis is based on number of implants (one participant had two implants). The total number of visits varies between different time points due to missed visits, and all available data is reported. Assessment of skin overgrowth was reported in a total of 22 unplanned visits.
Skin overgrowth over implant/abutment complex judged by the investigator by means of a Yes/No question. The results are presented for each study visit and for unplanned visits.
Outcome measures
| Measure |
Single-arm
n=265 Visits
In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
|
|---|---|
|
Skin Overgrowth
12 months : Yes
|
0 Visits
|
|
Skin Overgrowth
12 months : No
|
48 Visits
|
|
Skin Overgrowth
Unplanned visits : Yes
|
1 Visits
|
|
Skin Overgrowth
Unplanned visits : No
|
21 Visits
|
|
Skin Overgrowth
6 months : No
|
45 Visits
|
|
Skin Overgrowth
9 days : No
|
52 Visits
|
|
Skin Overgrowth
5 weeks : Yes
|
0 Visits
|
|
Skin Overgrowth
5 weeks : No
|
49 Visits
|
|
Skin Overgrowth
3 months : Yes
|
0 Visits
|
|
Skin Overgrowth
3 months : No
|
49 Visits
|
|
Skin Overgrowth
6 months : Yes
|
0 Visits
|
|
Skin Overgrowth
9 days : Yes
|
0 Visits
|
SECONDARY outcome
Timeframe: 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visitsPopulation: The analysis is based on number of implants (one participant had two implants). The total number of visits varies between different time points due to missed visits, and all available data is reported. For one visit, two post-operative events were reported for the same implant. Post-operative events were reported in a total of 25 unplanned visits.
Assessment of post-operative events by investigator into five different categories: None, Bleeding and/or hematoma, Hair in-growth, Skin dehiscence around abutment, and Other. The results are presented based on post-operative event distribution across all study visits, as well as separate for each study visit and unplanned visits.
Outcome measures
| Measure |
Single-arm
n=269 Visits
In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
|
|---|---|
|
Post-operative Events Around Abutment
All study visits: None
|
240 Visits
|
|
Post-operative Events Around Abutment
All study visits : Bleeding and/or hematoma
|
3 Visits
|
|
Post-operative Events Around Abutment
All study visits : Hair in-growth
|
1 Visits
|
|
Post-operative Events Around Abutment
All study visits : Skin dehiscence around abutment
|
18 Visits
|
|
Post-operative Events Around Abutment
All study visits : Other
|
7 Visits
|
|
Post-operative Events Around Abutment
9 days : None
|
39 Visits
|
|
Post-operative Events Around Abutment
9 days : Bleeding and/or hematoma
|
0 Visits
|
|
Post-operative Events Around Abutment
9 days : Hair in-growth
|
0 Visits
|
|
Post-operative Events Around Abutment
9 days : Skin dehiscence around abutment
|
13 Visits
|
|
Post-operative Events Around Abutment
9 days : Other
|
0 Visits
|
|
Post-operative Events Around Abutment
5 weeks : None
|
45 Visits
|
|
Post-operative Events Around Abutment
5 weeks : Bleeding and/or hematoma
|
1 Visits
|
|
Post-operative Events Around Abutment
5 weeks : Hair in-growth
|
0 Visits
|
|
Post-operative Events Around Abutment
5 weeks : Skin dehiscence around abutment
|
2 Visits
|
|
Post-operative Events Around Abutment
5 weeks : Other
|
2 Visits
|
|
Post-operative Events Around Abutment
3 months : None
|
44 Visits
|
|
Post-operative Events Around Abutment
3 months : Bleeding and/or hematoma
|
1 Visits
|
|
Post-operative Events Around Abutment
3 months : Hair in-growth
|
0 Visits
|
|
Post-operative Events Around Abutment
3 months : Skin dehiscence around abutment
|
1 Visits
|
|
Post-operative Events Around Abutment
3 months : Other
|
3 Visits
|
|
Post-operative Events Around Abutment
6 months : None
|
43 Visits
|
|
Post-operative Events Around Abutment
6 months : Bleeding and/or hematoma
|
0 Visits
|
|
Post-operative Events Around Abutment
6 months : Hair in-growth
|
0 Visits
|
|
Post-operative Events Around Abutment
6 months : Skin dehiscence around abutment
|
2 Visits
|
|
Post-operative Events Around Abutment
6 months : Other
|
0 Visits
|
|
Post-operative Events Around Abutment
12 months : None
|
47 Visits
|
|
Post-operative Events Around Abutment
12 months : Bleeding and/or hematoma
|
0 Visits
|
|
Post-operative Events Around Abutment
12 months : Hair in-growth
|
1 Visits
|
|
Post-operative Events Around Abutment
12 months : Skin dehiscence around abutment
|
0 Visits
|
|
Post-operative Events Around Abutment
12 months : Other
|
0 Visits
|
|
Post-operative Events Around Abutment
Unplanned visits : None
|
22 Visits
|
|
Post-operative Events Around Abutment
Unplanned visits : Bleeding and/or hematoma
|
1 Visits
|
|
Post-operative Events Around Abutment
Unplanned visits : Hair in-growth
|
0 Visits
|
|
Post-operative Events Around Abutment
Unplanned visits : Skin dehiscence around abutment
|
0 Visits
|
|
Post-operative Events Around Abutment
Unplanned visits : Other
|
2 Visits
|
SECONDARY outcome
Timeframe: 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visitsPopulation: The analysis is based on number of implants (one participant had two implants). The total number of visits varies between different time points due to missed visits, and all available data is reported. Assessment of pain was reported in a total of 23 unplanned visits.
Assessment of presence of patient-perceived pain by means of a Yes/No question to the subject.
Outcome measures
| Measure |
Single-arm
n=266 Visits
In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
|
|---|---|
|
Patient-perceived Presence of Pain Around Abutment
All study visits : No
|
204 Visits
|
|
Patient-perceived Presence of Pain Around Abutment
All study visits : Yes
|
62 Visits
|
|
Patient-perceived Presence of Pain Around Abutment
9 days : No
|
31 Visits
|
|
Patient-perceived Presence of Pain Around Abutment
9 days : Yes
|
21 Visits
|
|
Patient-perceived Presence of Pain Around Abutment
5 weeks : No
|
39 Visits
|
|
Patient-perceived Presence of Pain Around Abutment
5 weeks : Yes
|
10 Visits
|
|
Patient-perceived Presence of Pain Around Abutment
3 months : No
|
36 Visits
|
|
Patient-perceived Presence of Pain Around Abutment
3 months : Yes
|
13 Visits
|
|
Patient-perceived Presence of Pain Around Abutment
6 months : No
|
41 Visits
|
|
Patient-perceived Presence of Pain Around Abutment
6 months : Yes
|
4 Visits
|
|
Patient-perceived Presence of Pain Around Abutment
12 months : No
|
38 Visits
|
|
Patient-perceived Presence of Pain Around Abutment
12 months : Yes
|
10 Visits
|
|
Patient-perceived Presence of Pain Around Abutment
Unplanned visits : No
|
19 Visits
|
|
Patient-perceived Presence of Pain Around Abutment
Unplanned visits : Yes
|
4 Visits
|
SECONDARY outcome
Timeframe: 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visitsPopulation: The analysis is based on number of implants (one participant had two implants). The total number of visits varies between different time points due to missed visits, and all available data is reported. Assessment of numbness was reported in a total of 23 unplanned visits.
Assessment of presence of patient-perceived numbness by means of a Yes/No question to the patient.
Outcome measures
| Measure |
Single-arm
n=266 Visits
In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
|
|---|---|
|
Patient-perceived Presence of Numbness Around Abutment
12 months : No numbness
|
48 Visits
|
|
Patient-perceived Presence of Numbness Around Abutment
12 months : Presence of numbness
|
0 Visits
|
|
Patient-perceived Presence of Numbness Around Abutment
Unplanned visits : No numbness
|
22 Visits
|
|
Patient-perceived Presence of Numbness Around Abutment
Unplanned visits : Presence of numbness
|
1 Visits
|
|
Patient-perceived Presence of Numbness Around Abutment
All study visits : No numbness
|
254 Visits
|
|
Patient-perceived Presence of Numbness Around Abutment
All study visits : Presence of numbness
|
12 Visits
|
|
Patient-perceived Presence of Numbness Around Abutment
9 days : No numbness
|
48 Visits
|
|
Patient-perceived Presence of Numbness Around Abutment
9 days : Presence of numbness
|
4 Visits
|
|
Patient-perceived Presence of Numbness Around Abutment
5 weeks : No numbness
|
46 Visits
|
|
Patient-perceived Presence of Numbness Around Abutment
5 weeks : Presence of numbness
|
3 Visits
|
|
Patient-perceived Presence of Numbness Around Abutment
3 months : No numbness
|
46 Visits
|
|
Patient-perceived Presence of Numbness Around Abutment
3 months : Presence of numbness
|
3 Visits
|
|
Patient-perceived Presence of Numbness Around Abutment
6 months : No numbness
|
44 Visits
|
|
Patient-perceived Presence of Numbness Around Abutment
6 months : Presence of numbness
|
1 Visits
|
SECONDARY outcome
Timeframe: 3 months after implant surgeryLength of surgery measured in minutes.
Outcome measures
| Measure |
Single-arm
n=52 Implants
In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
|
|---|---|
|
Duration of Surgery
|
10.0 minutes
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: 12 months after implant surgeryPopulation: Participants using the sound processor daily at 12 months after surgery
Average sound processor usage time.
Outcome measures
| Measure |
Single-arm
n=45 Participants
In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
|
|---|---|
|
Sound Processor Usage
|
13.0 hours per day
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 3 months after surgeryPopulation: Number of participants answering the GBI questionnaire at 3 months
The Glasgow Benefit Inventory (GBI) is a validated, 18-item patient-reported questionnaire that assesses changes in health-related quality-of-life following otorhinolaryngological (ENT) interventions. The questionnaire evaluates the perceived benefit after a procedure and generates a Total Score and three subscale scores: General (12 items), Social Support (3 items), and Physical Health (3 items). Each score ranges from -100 to +100, where positive values indicate improvement, negative values indicate deterioration, and zero reflects no change. The Total Score is calculated as the mean of all item scores (not a sum of subscale scores), while each subscale score is calculated as the mean of the items belonging to that subscale.
Outcome measures
| Measure |
Single-arm
n=46 Participants
In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
|
|---|---|
|
Subjective Benefit After Surgery
Total score
|
26.8 Score
Standard Deviation 18.0
|
|
Subjective Benefit After Surgery
General score
|
37.7 Score
Standard Deviation 24.7
|
|
Subjective Benefit After Surgery
Social support score
|
9.1 Score
Standard Deviation 19.5
|
|
Subjective Benefit After Surgery
Physical support score
|
1.45 Score
Standard Deviation 24.3
|
Adverse Events
Single-arm
Serious adverse events
| Measure |
Single-arm
n=51 participants at risk
In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
|
|---|---|
|
Nervous system disorders
Pain (abdomen, back)
|
2.0%
1/51 • Number of events 2 • 12 months
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational medical device.
|
Other adverse events
| Measure |
Single-arm
n=51 participants at risk
In this single-arm study the patients undergo a minimally invasive surgery to recieve a bone anchored hearing system. After implantation, the patients re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
|
|---|---|
|
Nervous system disorders
Pain
|
11.8%
6/51 • Number of events 7 • 12 months
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational medical device.
|
|
Infections and infestations
Infection
|
7.8%
4/51 • Number of events 5 • 12 months
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational medical device.
|
|
Blood and lymphatic system disorders
Bleeding
|
5.9%
3/51 • Number of events 3 • 12 months
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational medical device.
|
|
Skin and subcutaneous tissue disorders
Inflammation
|
5.9%
3/51 • Number of events 3 • 12 months
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational medical device.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place