Trial Outcomes & Findings for Lab Evaluation of Novel Hearing Aid Coupling Method (NCT NCT05377359)
NCT ID: NCT05377359
Last Updated: 2025-03-28
Results Overview
Hearing aid recordings of different coupling options will be presented via a Multiple Stimuli with Reference and Anchor (MUSHRA) paradigm, where participants will rate and compare sound quality attributes between them. Ratings will be made on a scale where 0 would the minimum value and 100 would be the maximum value. Fullness: Higher scores indicate that participants found the recording to be fuller (thicker/richer sound). Higher scores indicate a better outcome. Sharpness: Higher scores indicate that participants found the recording to be sharper (thinner/more shrill). Lower scores indicate a better outcome. Overall Impression: Higher scores indicate that participants had an increased preference towards the recording when compared to the other recordings. Higher scores indicate a better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
60 minutes
Results posted on
2025-03-28
Participant Flow
Participant milestones
| Measure |
Participants With Hearing Loss
Individuals with hearing loss that meet the candidacy to wear hearing aids with various coupling methods. All participants will be exposed to all interventions in a single session
Recordings of Hearing Aids with Open Domes: Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled to open domes. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.
Recordings of Hearing Aids with Closed Domes: Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with closed domes. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.
Recordings of Hearing Aids with Novel State 1: Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with the new coupling method in its first state. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.
Recordings of Hearing Aids with Novel State 2: Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with the new coupling method in its second state. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.
|
|---|---|
|
Intake and Consent Form Completion
STARTED
|
20
|
|
Intake and Consent Form Completion
COMPLETED
|
20
|
|
Intake and Consent Form Completion
NOT COMPLETED
|
0
|
|
Breaks Between Appointment 1 and 2
STARTED
|
20
|
|
Breaks Between Appointment 1 and 2
COMPLETED
|
20
|
|
Breaks Between Appointment 1 and 2
NOT COMPLETED
|
0
|
|
Streaming Sound Quality Task
STARTED
|
20
|
|
Streaming Sound Quality Task
COMPLETED
|
20
|
|
Streaming Sound Quality Task
NOT COMPLETED
|
0
|
|
Situational Preference Task
STARTED
|
20
|
|
Situational Preference Task
COMPLETED
|
20
|
|
Situational Preference Task
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
| Measure |
Participants With Hearing Loss
n=20 Participants
All participants will be assessed under all interventions.
Recordings of Hearing Aids with Open Domes: Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled to open domes. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.
Recordings of Hearing Aids with Closed Domes: Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with closed domes. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.
Recordings of Hearing Aids with Novel State 1: Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with the new coupling method in its first state. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.
Recordings of Hearing Aids with Novel State 2: Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with the new coupling method in its second state. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.
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|---|---|
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Age, Continuous
|
75 Years
n=20 Participants
|
|
Sex: Female, Male
Female
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10 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=20 Participants
|
|
Hearing Thresholds
|
41 dB HL (decibel Hearing Loss)
n=20 Participants
|
|
Hearing aid experience
|
7.73 years
n=20 Participants
|
PRIMARY outcome
Timeframe: 60 minutesHearing aid recordings of different coupling options will be presented via a Multiple Stimuli with Reference and Anchor (MUSHRA) paradigm, where participants will rate and compare sound quality attributes between them. Ratings will be made on a scale where 0 would the minimum value and 100 would be the maximum value. Fullness: Higher scores indicate that participants found the recording to be fuller (thicker/richer sound). Higher scores indicate a better outcome. Sharpness: Higher scores indicate that participants found the recording to be sharper (thinner/more shrill). Lower scores indicate a better outcome. Overall Impression: Higher scores indicate that participants had an increased preference towards the recording when compared to the other recordings. Higher scores indicate a better outcome.
Outcome measures
| Measure |
Sound Quality Ratings
n=20 Participants
All 20 participants were asked to listen to various recorded stimuli and were asked to rate preference for each stimuli based on certain sound quality attributes (overall impression, sharpness, and fullness).
All 4 interventions were implemented at once (as is the nature of the MUSHRA) and ratings were made at the same time.
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|---|---|
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Sound Quality Ratings While Streaming
Open Domes - Speech - Fullness
|
57.875 Units on a rating scale
Interval 5.0 to 93.0
|
|
Sound Quality Ratings While Streaming
Vented Domes - Speech - Fullness
|
64.1 Units on a rating scale
Interval 23.0 to 94.0
|
|
Sound Quality Ratings While Streaming
State 2 - Speech - Fullness
|
60.3 Units on a rating scale
Interval 31.0 to 93.0
|
|
Sound Quality Ratings While Streaming
State 1 - Speech - Fullness
|
59.875 Units on a rating scale
Interval 29.0 to 94.0
|
|
Sound Quality Ratings While Streaming
Open Domes - Pop - Overall Impression
|
43.15 Units on a rating scale
Interval 1.0 to 83.0
|
|
Sound Quality Ratings While Streaming
Vented Domes - Pop - Overall Impression
|
60.025 Units on a rating scale
Interval 17.0 to 91.0
|
|
Sound Quality Ratings While Streaming
State 2 - Pop - Overall Impression
|
64.025 Units on a rating scale
Interval 34.0 to 96.0
|
|
Sound Quality Ratings While Streaming
State 1 - Pop - Overall Impression
|
49.00 Units on a rating scale
Interval 11.0 to 91.0
|
|
Sound Quality Ratings While Streaming
Open Domes - Speech - Overall Impression
|
62.9 Units on a rating scale
Interval 13.0 to 93.0
|
|
Sound Quality Ratings While Streaming
Vented Domes - Speech - Overall Impression
|
68.325 Units on a rating scale
Interval 35.0 to 94.0
|
|
Sound Quality Ratings While Streaming
State 2 - Speech - Overall Impression
|
67.575 Units on a rating scale
Interval 30.0 to 95.0
|
|
Sound Quality Ratings While Streaming
State 1 - Speech - Overall Impression
|
67.65 Units on a rating scale
Interval 23.0 to 95.0
|
|
Sound Quality Ratings While Streaming
Open Domes - Classical - Overall Impression
|
68.525 Units on a rating scale
Interval 0.0 to 94.0
|
|
Sound Quality Ratings While Streaming
Vented Domes - Classical - Overall Impression
|
71.775 Units on a rating scale
Interval 35.0 to 94.0
|
|
Sound Quality Ratings While Streaming
State 2 - Classical - Overall Impression
|
65.725 Units on a rating scale
Interval 35.0 to 92.0
|
|
Sound Quality Ratings While Streaming
State 1 - Classical - Overall Impression
|
61.525 Units on a rating scale
Interval 31.0 to 92.0
|
|
Sound Quality Ratings While Streaming
Open Domes - Pop - Sharpness
|
68.175 Units on a rating scale
Interval 23.0 to 93.0
|
|
Sound Quality Ratings While Streaming
Vented Domes - Pop - Sharpness
|
55.875 Units on a rating scale
Interval 15.0 to 92.0
|
|
Sound Quality Ratings While Streaming
State 2 - Pop - Sharpness
|
49.725 Units on a rating scale
Interval 7.0 to 92.0
|
|
Sound Quality Ratings While Streaming
State 1 - Pop - Sharpness
|
57.725 Units on a rating scale
Interval 29.0 to 88.0
|
|
Sound Quality Ratings While Streaming
Open Domes - Classical - Sharpness
|
61.875 Units on a rating scale
Interval 17.0 to 95.0
|
|
Sound Quality Ratings While Streaming
Vented Domes - Classical - Sharpness
|
57.1 Units on a rating scale
Interval 3.0 to 95.0
|
|
Sound Quality Ratings While Streaming
State 2 - Classical - Sharpness
|
61.75 Units on a rating scale
Interval 20.0 to 95.0
|
|
Sound Quality Ratings While Streaming
State 1 - Classical - Sharpness
|
60.275 Units on a rating scale
Interval 13.0 to 92.0
|
|
Sound Quality Ratings While Streaming
Open Domes - Speech - Sharpness
|
56.95 Units on a rating scale
Interval 10.0 to 93.0
|
|
Sound Quality Ratings While Streaming
Vented Domes - Speech - Sharpness
|
46.5 Units on a rating scale
Interval 10.0 to 96.0
|
|
Sound Quality Ratings While Streaming
State 2 - Speech - Sharpness
|
54.525 Units on a rating scale
Interval 10.0 to 95.0
|
|
Sound Quality Ratings While Streaming
State 1 - Speech - Sharpness
|
51.275 Units on a rating scale
Interval 12.0 to 93.0
|
|
Sound Quality Ratings While Streaming
Open Domes - Pop - Fullness
|
45.525 Units on a rating scale
Interval 14.0 to 90.0
|
|
Sound Quality Ratings While Streaming
Vented Domes - Pop - Fullness
|
61.525 Units on a rating scale
Interval 17.0 to 95.0
|
|
Sound Quality Ratings While Streaming
State 2 - Pop - Fullness
|
66.55 Units on a rating scale
Interval 11.0 to 91.0
|
|
Sound Quality Ratings While Streaming
State 1 - Pop - Fullness
|
51.725 Units on a rating scale
Interval 30.0 to 91.0
|
|
Sound Quality Ratings While Streaming
Open Domes - Classical - Fullness
|
60.8 Units on a rating scale
Interval 0.0 to 91.0
|
|
Sound Quality Ratings While Streaming
Vented Domes - Classical - Fullness
|
67.125 Units on a rating scale
Interval 28.0 to 99.0
|
|
Sound Quality Ratings While Streaming
State 2 - Classical - Fullness
|
58.425 Units on a rating scale
Interval 26.0 to 92.0
|
|
Sound Quality Ratings While Streaming
State 1 - Classical - Fullness
|
59.025 Units on a rating scale
Interval 25.0 to 91.0
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SECONDARY outcome
Timeframe: 60 MinutesPopulation: This is a single arm study, where the arm is participants with hearing loss and who are exposed to multiple interventions (i.e., open domes, closed domes, state 1, and state 2) within-subjects design.
Hearing aid recordings of different listening situations through different coupling options will be presented via a Multiple Stimuli with Reference and Anchor (MUSHRA) paradigm, where participants will indicate preferences between different recordings. Ratings will be made on a scale where 0 would the minimum value and 100 would be the maximum value. Higher scores indicate increased preferred sound quality. Higher scores will indicate that participants had an increased preference towards that recording when compared to the other recordings. In this measure, on
Outcome measures
| Measure |
Sound Quality Ratings
n=20 Participants
All 20 participants were asked to listen to various recorded stimuli and were asked to rate preference for each stimuli based on certain sound quality attributes (overall impression, sharpness, and fullness).
All 4 interventions were implemented at once (as is the nature of the MUSHRA) and ratings were made at the same time.
|
|---|---|
|
Situational Preference Ratings
State 2 - Mic Off - Music - Stream
|
82.225 Units on a rating scale
Interval 64.0 to 100.0
|
|
Situational Preference Ratings
State 2 - Mic On - Music - Stream
|
23.125 Units on a rating scale
Interval 2.0 to 70.0
|
|
Situational Preference Ratings
State 1 - Mic Off - Music - Stream
|
50.35 Units on a rating scale
Interval 6.0 to 99.0
|
|
Situational Preference Ratings
State 1 - Mic On - Music - Stream
|
21.95 Units on a rating scale
Interval 2.0 to 59.0
|
|
Situational Preference Ratings
State 2 - Mic Off - Speech - Stream
|
84.225 Units on a rating scale
Interval 9.0 to 98.0
|
|
Situational Preference Ratings
State 2 - Mic On - Speech - Stream
|
29.2 Units on a rating scale
Interval 2.0 to 72.0
|
|
Situational Preference Ratings
State 1 - Mic Off - Speech - Stream
|
63.175 Units on a rating scale
Interval 27.0 to 98.0
|
|
Situational Preference Ratings
State 1 - Mic On - Speech - Stream
|
28.925 Units on a rating scale
Interval 2.0 to 72.0
|
|
Situational Preference Ratings
State 2 - Mic Off - Music - Noise
|
37.6 Units on a rating scale
Interval 1.0 to 99.0
|
|
Situational Preference Ratings
State 2 - Mic On - Music - Noise
|
42.55 Units on a rating scale
Interval 0.0 to 90.0
|
|
Situational Preference Ratings
State 1 - Mic Off - Music - Noise
|
45.90 Units on a rating scale
Interval 10.0 to 79.0
|
|
Situational Preference Ratings
State 1 - Mic On - Music - Noise
|
43.675 Units on a rating scale
Interval 1.0 to 89.0
|
|
Situational Preference Ratings
State 2 - Mic Off - Speech - Noise
|
43.1 Units on a rating scale
Interval 0.0 to 97.0
|
|
Situational Preference Ratings
State 2 - Mic On - Speech - Noise
|
41.675 Units on a rating scale
Interval 2.0 to 87.0
|
|
Situational Preference Ratings
State 1 - Mic Off - Speech - Noise
|
51.225 Units on a rating scale
Interval 5.0 to 96.0
|
|
Situational Preference Ratings
State 1 - Mic On - Speech - Noise
|
39.625 Units on a rating scale
Interval 3.0 to 73.0
|
Adverse Events
Participants With Hearing Loss - Intake and Consent Form
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Participants With Hearing Loss - Streaming Sound Quality Task
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Participants With Hearing Loss - Situational Preference Task
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place