Trial Outcomes & Findings for Evaluation of Sound Processor for a Transcutaneous System (NCT NCT03374787)

Results Overview

Difference between Fusion-aided and unaided sound field Pure Tone Average of thresholds of frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

6 months

Results posted on

2025-03-17

Participant Flow

Participant milestones

Participant milestones
Measure	Fusion Sound Processor The group is fitted with a Fusion Sound Processor. The sound processor picks up the sound and transfer it to the implant that convert the sound to vibrations that are transmitted to the inner ear.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fusion Sound Processor n=10 Participants The group is fitted with a Fusion Sound Processor. The sound processor picks up the sound and transfer it to the implant that convert the sound to vibrations that are transmitted to the inner ear.
Age, Continuous	46.7 years n=10 Participants
Sex: Female, Male Female	6 Participants n=10 Participants
Sex: Female, Male Male	4 Participants n=10 Participants
Region of Enrollment Sweden	10 participants n=10 Participants

PRIMARY outcome

Timeframe: 6 months

Difference between Fusion-aided and unaided sound field Pure Tone Average of thresholds of frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)

Outcome measures

Outcome measures
Measure	Fusion Sound Processor n=10 Participants The group is fitted with a Fusion Sound Processor. The sound processor picks up the sound and transfer it to the implant that convert the sound to vibrations that are transmitted to the inner ear.
Aided Thresholds Fusion-unaided PTA	29.6 dB Standard Deviation 4.4

SECONDARY outcome

Timeframe: 6 months

Difference between Fusion-aided and unaided sound field Pure Tone thresholds at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz

Outcome measures

Outcome measures
Measure	Fusion Sound Processor n=10 Participants The group is fitted with a Fusion Sound Processor. The sound processor picks up the sound and transfer it to the implant that convert the sound to vibrations that are transmitted to the inner ear.
Aided Thresholds Fusion-unaided 250	10.05 dB Standard Deviation 5.5
Aided Thresholds Fusion-unaided 500	26.5 dB Standard Deviation 7.5
Aided Thresholds Fusion-unaided 750	36.5 dB Standard Deviation 5.3
Aided Thresholds Fusion-unaided 1000	38.0 dB Standard Deviation 7.9
Aided Thresholds Fusion-unaided 1500	28.5 dB Standard Deviation 6.7
Aided Thresholds Fusion-unaided 2000	27.5 dB Standard Deviation 8.2
Aided Thresholds Fusion-unaided 3000	25.0 dB Standard Deviation 8.2
Aided Thresholds Fusion-unaided 4000	26.5 dB Standard Deviation 7.8
Aided Thresholds Fusion-unaided 6000	22.5 dB Standard Deviation 8.6
Aided Thresholds Fusion-unaided 8000	17.5 dB Standard Deviation 10.1

SECONDARY outcome

Timeframe: Baseline, 1 and 6 month(s)

Difference between Fusion-aided sound field PTA4, the average for frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)

Outcome measures

Outcome measures
Measure	Fusion Sound Processor n=10 Participants The group is fitted with a Fusion Sound Processor. The sound processor picks up the sound and transfer it to the implant that convert the sound to vibrations that are transmitted to the inner ear.
Aided Thresholds Fusion PTA4 Difference between 0-1 months	-0.290 dB Standard Deviation 1.386
Aided Thresholds Fusion PTA4 Difference between 0-6 months	-1.07 dB Standard Deviation 2.93
Aided Thresholds Fusion PTA4 Difference between 1-6 months	-0.78 dB Standard Deviation 2.754

SECONDARY outcome

Timeframe: Baseline, 1 and 6 month(s)

Difference between Fusion-aided sound field pure tones at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz at

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Difference between Fusion-aided and BCI-aided sound field Pure Tone Average 4 at frequencies 500, 1000, 2000 and 4000 Hz (PTA4)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Difference between Fusion-aided and BCI-aided sound field pure tones at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Difference between Fusion-aided and unaided speech intelligibility scores (in % correct). Score indicates number of word repeated correctly with aided with the Fusion sound processor compared to unaided. Ranges from 0-100, a higher score indicates better performance. No scale is used.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Difference between Fusion-aided and unaided sound field speech intelligibility scores in SNR. Score indicates the signal to noise ratio where the subject can repeat 50% of the words correct. A lower score means a better outcome. No scale is used.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 1 and 6 month(s)

Difference between Fusion-aided speech intelligibility scores (in % correct). Score indicates number of word repeated correctly with aided with the Fusion sound processor compared to unaided. Ranges from 0-100, a higher score indicates better performance. No scale is used.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 1 and 6 month(s)

Difference between Fusion-aided sound field sound field speech intelligibility scores in SNR. Score indicates the signal to noise ratio where the subject can repeat 50% of the words correct. A lower score means a better outcome. No scale is used.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Difference between Fusion-aided BCI-aided speech intelligibility scores (in % correct). Score indicates number of word repeated correctly with aided with the Fusion sound processor compared to unaided. Ranges from 0-100, a higher score indicates better performance. No scale is used

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Difference between Fusion-aided and BCI-aided sound field speech intelligibility scores in SNR. Score indicates the signal to noise ratio where the subject can repeat 50% of the words correct. A lower score means a better outcome. No scale is used.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 1 and 6 month(s)

Difference in magnet strength measured on the patient's heads in Newton

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 1 and 6 month(s)

Combined score of IInflammation, Pain and Skin height/numbness scale evaluating the skin area under the sound processor. I scale ranging from 0-4, Pain scale ranging from 0-2, Skin height/numbness ranging from 0-2. Total score 0-8 (0 no adverse skin condition, 8 maximum adverse skin reactions on all subscales). Lower score means better performance

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 1 and 6 month(s)

User satisfaction and usability as measured with questionniare "Usage of sound processor" consisting of rating scales on satisfaction of the sound processor. The scale used is a scale with descriptive values.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 1 and 6 month(s)

Subjective performance as measured by Speech, Spatial and Qualities of hearing (SSQ) a scale from 0-10 where 0 represents "Not at all" and 10 represents "Perfect". A higher score means better performance.

Outcome measures

Outcome data not reported

Adverse Events

Fusion Sound Processor

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fusion Sound Processor n=10 participants at risk The group is fitted with a Fusion Sound Processor. The sound processor picks up the sound and transfer it to the implant that convert the sound to vibrations that are transmitted to the inner ear.
General disorders Implant site pain	10.0% 1/10 • Number of events 1 • 7 months
General disorders Implat site paraesthesia	10.0% 1/10 • Number of events 1 • 7 months
General disorders Medical device site irritation	10.0% 1/10 • Number of events 1 • 7 months
General disorders Pyrexia	10.0% 1/10 • 7 months
Immune system disorders Seasonal allergy	10.0% 1/10 • Number of events 1 • 7 months
Infections and infestations Ear infection	10.0% 1/10 • Number of events 1 • 7 months
Infections and infestations Nasopharyngitis	20.0% 2/10 • Number of events 2 • 7 months
Injury, poisoning and procedural complications Ankle fracture	10.0% 1/10 • Number of events 1 • 7 months
Injury, poisoning and procedural complications Arthropod bite	10.0% 1/10 • Number of events 1 • 7 months
Injury, poisoning and procedural complications Ligament rupture	10.0% 1/10 • Number of events 1 • 7 months
Injury, poisoning and procedural complications Ligament sprain	10.0% 1/10 • Number of events 1 • 7 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	10.0% 1/10 • Number of events 1 • 7 months
Nervous system disorders Headache	10.0% 1/10 • Number of events 1 • 7 months

Additional Information

Director of Clinical Affairs

Oticon Medical

Phone: 0046-31-7486100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place