Trial Outcomes & Findings for Compression Headphone Study (NCT NCT04882709)
NCT ID: NCT04882709
Last Updated: 2025-08-13
Results Overview
Participants moved through a self-guided, double-blinded sound survey which presented sound samples of all hearing aid conditions (see Arms/Groups for conditions) and asked participants to rate the sound quality dimensions on a scale. The rating dimensions and scales were based on a sound quality rating guidance document by Delta Labs (Danmark) ranging from 0 to 100 with step sizes of 1 and descriptive markers at 0 (worst), 20, 40, 60, 80 and 100 (best) depending on the dimension (Reverberation (only assessed for Speech in Quiet and Reverberant Speech), Sound Source Localization, Sound Source Separation, and Timbral Balance). Overall Preference was implemented as a ranking according to the 5-point Mean Opinion Score (bad (1), poor (2), fair (3), good (4), excellent (5); MOS, International Telecommunication Union, 1996).
TERMINATED
NA
12 participants
1 hour
2025-08-13
Participant Flow
Participant milestones
| Measure |
Sound Survey
Each participant will conduct a sound survey at home with equipment (tablet and headphones) that were shipped to the participant's place of residence. During the survey, sound samples were randomly assigned to the push buttons participants were clicking to listen to a sound:
Hearing aid 1 default amplification strategy: A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with the default settings as specified in the study sponsor's fitting software.
Hearing aid 2: A receiver-in-canal (RIC) hearing aid developed by the another hearing aid manufacturer used with the default settings as specified in the manufacturer's fitting software.
Hearing aid 1 strategy 1: A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with a modified compression strategy that is expected to improve sound quality.
Hearing aid 1 strategy 2: A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with a modified compression strategy that is expected to improve sound quality.
Unaided: Recordings made without hearing aids. Ratings for this sound sample were used for normalization of survey results.
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|---|---|
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Overall Study
STARTED
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12
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Overall Study
Hearing Aid 1 Default Amplification Strategy
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12
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Overall Study
Hearing Aid 2
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12
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Overall Study
Hearing Aid 1 Strategy 1
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12
|
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Overall Study
Hearing Aid 1 Strategy 2
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12
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Overall Study
Unaided
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12
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Overall Study
COMPLETED
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12
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Complete Sample
n=11 Participants
Each participant will listen to sound samples via headphones. Sound samples have been recorded with each of the devices listed under "intervention" which were set to each participant's individual hearing loss, and an unaided reference. Participants will be asked to rate different aspects of sound quality while listening to the different sound samples.
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|---|---|
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Age, Continuous
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68 years
STANDARD_DEVIATION 13 • n=11 Participants
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Sex: Female, Male
Female
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7 Participants
n=11 Participants
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Sex: Female, Male
Male
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4 Participants
n=11 Participants
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Hearing aid experience
|
17 years
STANDARD_DEVIATION 10 • n=11 Participants
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Hearing loss
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11 Participants
n=11 Participants
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Normal or corrected to normal vision
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11 Participants
n=11 Participants
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Good cognitive abilities
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11 Participants
n=11 Participants
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PRIMARY outcome
Timeframe: 1 hourPopulation: The median and IQR is presented for each sound quality dimension (Reverberation, Sound Source Separation, Sound Source Location and Overall) in sound scene (speech in quiet, speech in noise, speech in reverberance, music).
Participants moved through a self-guided, double-blinded sound survey which presented sound samples of all hearing aid conditions (see Arms/Groups for conditions) and asked participants to rate the sound quality dimensions on a scale. The rating dimensions and scales were based on a sound quality rating guidance document by Delta Labs (Danmark) ranging from 0 to 100 with step sizes of 1 and descriptive markers at 0 (worst), 20, 40, 60, 80 and 100 (best) depending on the dimension (Reverberation (only assessed for Speech in Quiet and Reverberant Speech), Sound Source Localization, Sound Source Separation, and Timbral Balance). Overall Preference was implemented as a ranking according to the 5-point Mean Opinion Score (bad (1), poor (2), fair (3), good (4), excellent (5); MOS, International Telecommunication Union, 1996).
Outcome measures
| Measure |
Hearing Aid 1 Default Amplification Strategy
n=11 Participants
A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with the default settings as specified in the study sponsor's fitting software.
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Hearing Aid 2
n=11 Participants
A receiver-in-canal (RIC) hearing aid developed by the another hearing aid manufacturer used with the default settings as specified in the manufacturer's fitting software.
|
Hearing Aid 1 Strategy 1
n=11 Participants
A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with a modified compression strategy that is expected to improve sound quality.
|
Hearing Aid 1 Strategy 2
n=11 Participants
A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with a modified compression strategy that is expected to improve sound quality.
|
Unaided
n=11 Participants
A recording without any amplification.
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|---|---|---|---|---|---|
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Sound Quality Rating
Reverberation in speech in quiet
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69 units on a scale
Interval 55.0 to 75.0
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55 units on a scale
Interval 28.75 to 70.75
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71 units on a scale
Interval 64.75 to 87.75
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80 units on a scale
Interval 47.5 to 90.0
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42 units on a scale
Interval 26.0 to 59.0
|
|
Sound Quality Rating
Reverberation in reverberant speech
|
56.5 units on a scale
Interval 50.25 to 72.0
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54.5 units on a scale
Interval 41.0 to 70.5
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70 units on a scale
Interval 60.75 to 80.75
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70.5 units on a scale
Interval 51.25 to 73.75
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40.5 units on a scale
Interval 21.0 to 55.25
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Sound Quality Rating
Sound source location in speech in quiet
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59 units on a scale
Interval 54.25 to 70.75
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50.5 units on a scale
Interval 39.5 to 67.0
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61.5 units on a scale
Interval 52.75 to 78.0
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55 units on a scale
Interval 51.25 to 61.5
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25 units on a scale
Interval 16.0 to 37.5
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Sound Quality Rating
Sound source location in speech in noise
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74 units on a scale
Interval 63.0 to 80.25
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63 units on a scale
Interval 44.75 to 73.0
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65 units on a scale
Interval 50.0 to 78.5
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61 units on a scale
Interval 57.75 to 76.75
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43.5 units on a scale
Interval 25.5 to 62.75
|
|
Sound Quality Rating
Sound source localization in reverberant speech
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45.5 units on a scale
Interval 36.25 to 60.5
|
56 units on a scale
Interval 41.5 to 63.0
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69.5 units on a scale
Interval 51.0 to 73.0
|
55.5 units on a scale
Interval 50.75 to 67.25
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49 units on a scale
Interval 30.75 to 59.5
|
|
Sound Quality Rating
Sound source localization in music
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60.5 units on a scale
Interval 53.0 to 66.25
|
69.5 units on a scale
Interval 60.25 to 74.0
|
66.5 units on a scale
Interval 63.0 to 71.0
|
67.5 units on a scale
Interval 59.75 to 78.75
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44 units on a scale
Interval 24.25 to 56.25
|
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Sound Quality Rating
Sound source separation in speech in quiet
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62.5 units on a scale
Interval 53.25 to 74.0
|
59 units on a scale
Interval 56.75 to 71.25
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59.5 units on a scale
Interval 55.75 to 74.0
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69 units on a scale
Interval 52.0 to 76.75
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29 units on a scale
Interval 16.5 to 41.25
|
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Sound Quality Rating
Sound source separation in speech in noise
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55 units on a scale
Interval 46.75 to 57.25
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52 units on a scale
Interval 40.0 to 60.25
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70 units on a scale
Interval 53.5 to 75.25
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64.5 units on a scale
Interval 50.75 to 69.0
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30 units on a scale
Interval 16.0 to 40.0
|
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Sound Quality Rating
Sound source separation in reverberant speech
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50 units on a scale
Interval 36.75 to 54.5
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61 units on a scale
Interval 39.5 to 76.0
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61 units on a scale
Interval 53.25 to 65.25
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61 units on a scale
Interval 47.5 to 70.75
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39 units on a scale
Interval 30.25 to 55.5
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Sound Quality Rating
Sound source separation in music
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65.5 units on a scale
Interval 51.5 to 79.25
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71.5 units on a scale
Interval 40.0 to 76.75
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68.5 units on a scale
Interval 53.0 to 77.25
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79.5 units on a scale
Interval 71.0 to 80.5
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30 units on a scale
Interval 15.75 to 61.75
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Sound Quality Rating
Overall Preference for speech in quiet
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3.5 units on a scale
Interval 2.5 to 4.0
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3.5 units on a scale
Interval 3.0 to 3.5
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3.5 units on a scale
Interval 3.5 to 4.0
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4 units on a scale
Interval 3.25 to 4.0
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1 units on a scale
Interval 1.0 to 1.0
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Sound Quality Rating
Overall Preference for speech in noise
|
3.5 units on a scale
Interval 3.5 to 4.0
|
3.5 units on a scale
Interval 2.25 to 4.0
|
3.5 units on a scale
Interval 3.0 to 3.75
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3 units on a scale
Interval 3.0 to 3.75
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1 units on a scale
Interval 1.0 to 3.0
|
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Sound Quality Rating
Overall Preference for reverberant speech
|
3 units on a scale
Interval 1.75 to 3.5
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3 units on a scale
Interval 2.0 to 4.0
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4 units on a scale
Interval 3.5 to 4.0
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3.5 units on a scale
Interval 3.0 to 4.0
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3 units on a scale
Interval 1.25 to 3.5
|
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Sound Quality Rating
Overall Preference for music
|
3 units on a scale
Interval 2.25 to 3.75
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3 units on a scale
Interval 2.75 to 4.5
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3.5 units on a scale
Interval 3.0 to 3.75
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4 units on a scale
Interval 3.5 to 4.0
|
1 units on a scale
Interval 1.0 to 3.0
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Adverse Events
Complete Sample
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place