Trial Outcomes & Findings for Evaluation of a Hearing Device for Transmitting Sound to the Inner Ear (NCT NCT05628285)

NCT ID: NCT05628285

Last Updated: 2025-12-03

Results Overview

Functional gain with Sentio 1, i.e., the difference in dB between unaided and aided sound field thresholds, calculated on average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4). In detail, for each patient, sound field thresholds are measured at the frequencies 500, 1000, 2000 and 4000 Hz for which a mean value is calculated and denoted as PTA4. The primary outcome measure is functional gain which is the difference in PTA4 measured unaided (without sound processor) versus aided condition (with sound processor).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2025-12-03

Participant Flow

Unit of analysis: Ears

Participant milestones

Measure	Sentio 1 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. Sentio 1: Sound processor
Overall Study STARTED	11 11
Overall Study COMPLETED	10 10
Overall Study NOT COMPLETED	1 1

Reasons for withdrawal

Measure	Sentio 1 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. Sentio 1: Sound processor
Overall Study Lost to Follow-up	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Sentio 1 Sound Processor n=11 Participants 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. Sentio 1: Sound processor
Age, Continuous	51 years n=11 Participants
Sex: Female, Male Female	7 Participants n=11 Participants
Sex: Female, Male Male	4 Participants n=11 Participants

PRIMARY outcome

Timeframe: 1 month

Functional gain with Sentio 1, i.e., the difference in dB between unaided and aided sound field thresholds, calculated on average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4).

In detail, for each patient, sound field thresholds are measured at the frequencies 500, 1000, 2000 and 4000 Hz for which a mean value is calculated and denoted as PTA4.

The primary outcome measure is functional gain which is the difference in PTA4 measured unaided (without sound processor) versus aided condition (with sound processor).

Outcome measures

Measure	Functional Gain PTA4 (Sentio 1 Sound Processor) n=10 Ears 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. Sentio 1: Sound processor	Sentio 1 Sound Processor Measurement at Visit 2 with the Sentio 1 sound processor	Difference Between Visit 2 (Sentio 1) and Visit 1 (Previous Device) Visit 2 (Sentio 1) - Visit 1 (previous device)
To Assess the Improvement of Hearing With the Sentio1 (PTA4)	32.5 dB Standard Deviation 6.8	—	—

SECONDARY outcome

Timeframe: 1 month

Functional gain with Sentio 1, i.e., the difference in dB between unaided (without sound processor) and aided (with sound processor on) sound field thresholds, for all measured frequencies.

In detail, for each patient, sound field thresholds are measured at the frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz, with and without the sound processor on.

Outcome measures

Measure	Functional Gain PTA4 (Sentio 1 Sound Processor) n=10 Ears 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. Sentio 1: Sound processor	Sentio 1 Sound Processor Measurement at Visit 2 with the Sentio 1 sound processor	Difference Between Visit 2 (Sentio 1) and Visit 1 (Previous Device) Visit 2 (Sentio 1) - Visit 1 (previous device)
To Assess the Improvement of Hearing With the Sentio1 4000Hz	32.0 dB Standard Deviation 8.9	—	—
To Assess the Improvement of Hearing With the Sentio1 6000Hz	23.5 dB Standard Deviation 9.1	—	—
To Assess the Improvement of Hearing With the Sentio1 250Hz	18.5 dB Standard Deviation 11.6	—	—
To Assess the Improvement of Hearing With the Sentio1 500Hz	29.5 dB Standard Deviation 12.1	—	—
To Assess the Improvement of Hearing With the Sentio1 1000Hz	35.0 dB Standard Deviation 6.2	—	—
To Assess the Improvement of Hearing With the Sentio1 2000Hz	33.5 dB Standard Deviation 10.3	—	—
To Assess the Improvement of Hearing With the Sentio1 3000Hz	35.0 dB Standard Deviation 13.1	—	—
To Assess the Improvement of Hearing With the Sentio1 8000Hz	17.8 dB Standard Deviation 12.9	—	—

SECONDARY outcome

Timeframe: 1 month

Sentio 1 compared to previous sound processor.

1. Average SSQ12 scores with Sentio 1 for each question, sub-scales and in total.

2. Average SSQ12 scores with current sound processor for each question, sub-scales and in total.

3. Difference in SSQ12 scores between Sentio 1 and current sound processor for each question, sub-scales and in total.

Measured by the Speech, Spatial and Quality (SSQ) scale from 0-10 where 0 represents "Not at all" and 10 represents "Perfect". Higher scores mean a better outcome. For each of the scales the item outcomes are averaged. Fot the total score all items are averaged

Outcome measures

Measure	Functional Gain PTA4 (Sentio 1 Sound Processor) n=11 Ears 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. Sentio 1: Sound processor	Sentio 1 Sound Processor n=10 Ears Measurement at Visit 2 with the Sentio 1 sound processor	Difference Between Visit 2 (Sentio 1) and Visit 1 (Previous Device) n=10 Ears Visit 2 (Sentio 1) - Visit 1 (previous device)
Subjective Evaluation of Sound Processor Performance. SSQ Speech	5.58 score on a scale Standard Deviation 2.32	6.07 score on a scale Standard Deviation 2.67	0.579 score on a scale Standard Deviation 1.537
Subjective Evaluation of Sound Processor Performance. SSQ Spatial	4.34 score on a scale Standard Deviation 3.02	4.68 score on a scale Standard Deviation 2.90	0.353 score on a scale Standard Deviation 1.590
Subjective Evaluation of Sound Processor Performance. SSQ Quality	6.21 score on a scale Standard Deviation 2.12	6.22 score on a scale Standard Deviation 1.70	0.154 score on a scale Standard Deviation 0.920
Subjective Evaluation of Sound Processor Performance. SSQ Total	5.47 score on a scale Standard Deviation 2.18	5.78 score on a scale Standard Deviation 2.26	0.402 score on a scale Standard Deviation 0.937

SECONDARY outcome

Timeframe: 1 month

Percentage (%) of subjects who prefer the Sentio 1 over current sound processor

Outcome measures

Measure	Functional Gain PTA4 (Sentio 1 Sound Processor) n=10 Participants 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. Sentio 1: Sound processor	Sentio 1 Sound Processor Measurement at Visit 2 with the Sentio 1 sound processor	Difference Between Visit 2 (Sentio 1) and Visit 1 (Previous Device) Visit 2 (Sentio 1) - Visit 1 (previous device)
Subjective Sound Processor Preference	7 Participants	—	—

SECONDARY outcome

Timeframe: 1 month

1. Effective gain defined as the difference in dB between aided sound field thresholds with Sentio 1 and unmasked BC thresholds on the aided ear(s). The effective gain is calculated for all measured frequencies.

2. Effective gain with Sentio 1, see definition above, calculated in average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4).

Outcome measures

Measure	Functional Gain PTA4 (Sentio 1 Sound Processor) n=10 Participants 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. Sentio 1: Sound processor	Sentio 1 Sound Processor Measurement at Visit 2 with the Sentio 1 sound processor	Difference Between Visit 2 (Sentio 1) and Visit 1 (Previous Device) Visit 2 (Sentio 1) - Visit 1 (previous device)
To Assess the Degree to Which Sentio 1 Compensates for the BC Hearing Loss PTA4	11.9 dB Standard Deviation 7.7	—	—
To Assess the Degree to Which Sentio 1 Compensates for the BC Hearing Loss 3000Hz	12.5 dB Standard Deviation 9.2	—	—
To Assess the Degree to Which Sentio 1 Compensates for the BC Hearing Loss 500Hz	20.5 dB Standard Deviation 13.6	—	—
To Assess the Degree to Which Sentio 1 Compensates for the BC Hearing Loss 1000Hz	11.0 dB Standard Deviation 7.4	—	—
To Assess the Degree to Which Sentio 1 Compensates for the BC Hearing Loss 2000Hz	1.50 dB Standard Deviation 10.01	—	—
To Assess the Degree to Which Sentio 1 Compensates for the BC Hearing Loss 4000Hz	14.5 dB Standard Deviation 9.0	—	—

SECONDARY outcome

Timeframe: 1 month

Difference in dB between Sentio 1 BC in situ thresholds and BC thresholds measured with conventional unmasked BC audiometry for the frequencies 500, 1000, 2000, 3000 and 4000 Hz.

The BC in-situ threshold is a measure of the inner ear functionality with the device. This should correspond to the unmasked BC thresholds measured with conventional audiometry. The difference was calculated as the threshold value measured with Sentio 1 minus the threshold value measured with conventional audiometry. Negative values indicate that the thresholds measured with Sentio 1 were lower (better) compared to those measured with conventional audiometry. Conversely, positive values indicate that the thresholds measured with Sentio 1 were higher (worse) compared to conventional audiometry. It's expected that two measurements should be comparable to each with a difference of maximum +/-5 dB.

Outcome measures

Measure	Functional Gain PTA4 (Sentio 1 Sound Processor) n=11 Ears 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. Sentio 1: Sound processor	Sentio 1 Sound Processor Measurement at Visit 2 with the Sentio 1 sound processor	Difference Between Visit 2 (Sentio 1) and Visit 1 (Previous Device) Visit 2 (Sentio 1) - Visit 1 (previous device)
To Assess the Difference Between BC In-situ Thresholds Measured With Sentio 1 and Conventional Unmasked BC Audiometry. 500Hz	-4.7 dB Standard Error 11.5	—	—
To Assess the Difference Between BC In-situ Thresholds Measured With Sentio 1 and Conventional Unmasked BC Audiometry. 1000Hz	-3.4 dB Standard Error 9.0	—	—
To Assess the Difference Between BC In-situ Thresholds Measured With Sentio 1 and Conventional Unmasked BC Audiometry. 2000Hz	-6.7 dB Standard Error 7.9	—	—
To Assess the Difference Between BC In-situ Thresholds Measured With Sentio 1 and Conventional Unmasked BC Audiometry. 3000Hz	8.2 dB Standard Error 8.4	—	—
To Assess the Difference Between BC In-situ Thresholds Measured With Sentio 1 and Conventional Unmasked BC Audiometry. 4000Hz	9.9 dB Standard Error 9.2	—	—

SECONDARY outcome

Timeframe: 12 months

Tabulation of AEs occurred throughout the investigation and percentage of individuals with reported AEs.

Outcome measures

Outcome data not reported

Adverse Events

Sentio 1 Sound Processor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Affairs

Oticon Medical AB

Phone: 0046-31-7486100

Email: studyinfo@oticonmedical.com

Results disclosure agreements

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