Trial Outcomes & Findings for Sound Quality Comparisons With Different Hearing Aid Couplings and Venting Systems (NCT NCT05180630)
NCT ID: NCT05180630
Last Updated: 2023-06-28
Results Overview
subjective rating on scale from 0 (worst) to 100 (best) for sound quality of streamed signal
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
1 day
Results posted on
2023-06-28
Participant Flow
Participant milestones
| Measure |
Custom Earmolds, Then Open Domes, Then Vented Domes
Participants first fit with Audeo 90P hearing aids and custom earmold with dynamic venting, then fit with the same hearing aids using open domes, then fit with the same hearing aids using vented domes.
|
Open Domes, Then Vented Domes, Then Custom Earmolds
Participants first fit with Audeo 90P hearing aids and open domes, then fit with the same hearing aids using vented domes, then fit with the same hearing aids using custom earmolds with dynamic venting.
|
Vented Domes, Then Custom Earmolds, Then Open Domes
Participants first fit with Audeo 90P hearing aids and vented domes, then fit with the same hearing aids using custom earmolds with dynamic venting, then fit with the same hearing aids using open domes.
|
|---|---|---|---|
|
First Intervention
STARTED
|
6
|
6
|
5
|
|
First Intervention
COMPLETED
|
6
|
6
|
2
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
3
|
|
Second Intervention
STARTED
|
6
|
6
|
2
|
|
Second Intervention
COMPLETED
|
6
|
6
|
2
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
|
Third Intervention
STARTED
|
6
|
6
|
2
|
|
Third Intervention
COMPLETED
|
6
|
6
|
2
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Custom Earmolds, Then Open Domes, Then Vented Domes
Participants first fit with Audeo 90P hearing aids and custom earmold with dynamic venting, then fit with the same hearing aids using open domes, then fit with the same hearing aids using vented domes.
|
Open Domes, Then Vented Domes, Then Custom Earmolds
Participants first fit with Audeo 90P hearing aids and open domes, then fit with the same hearing aids using vented domes, then fit with the same hearing aids using custom earmolds with dynamic venting.
|
Vented Domes, Then Custom Earmolds, Then Open Domes
Participants first fit with Audeo 90P hearing aids and vented domes, then fit with the same hearing aids using custom earmolds with dynamic venting, then fit with the same hearing aids using open domes.
|
|---|---|---|---|
|
First Intervention
Physician Decision
|
0
|
0
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Study Group
n=14 Participants
Group will be fit using three different hearing aid couplings. Each participant will be supplying a rating of sound quality for each condition.
Audeo P90 hearing aid with compatible couplings: Audeo P90 hearing aids will be fit with three different compatible couplings.
|
|---|---|
|
Age, Continuous
|
71 years
n=14 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=14 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=14 Participants
|
|
Mild to moderate hearing loss
|
14 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: All participants who evaluated the sound quality of streamed music using all three coupling systems.
subjective rating on scale from 0 (worst) to 100 (best) for sound quality of streamed signal
Outcome measures
| Measure |
Custom Earmolds, Then Open Domes, Then Vented Domes
n=6 Participants
Participants first fit with Audeo 90P hearing aids and custom earmold with dynamic venting, then fit with the same hearing aids using open domes, then fit with the same hearing aids using vented domes.
|
Open Domes, Then Vented Domes, Then Custom Earmolds
n=6 Participants
Participants first fit with Audeo 90P hearing aids and open domes, then fit with the same hearing aids using vented domes, then fit with the same hearing aids using custom earmolds with dynamic venting.
|
Vented Domes, Then Custom Earmolds, Then Open Domes
n=2 Participants
Participants first fit with Audeo 90P hearing aids and vented domes, then fit with the same hearing aids using custom earmolds with dynamic venting, then fit with the same hearing aids using open domes.
|
|---|---|---|---|
|
Sound Quality of Streamed Music Rating Scale
Subjective sound quality rating of streamed music with custom earmolds
|
84 score on a scale
Interval 75.0 to 100.0
|
70 score on a scale
Interval 25.0 to 100.0
|
70 score on a scale
Interval 60.0 to 80.0
|
|
Sound Quality of Streamed Music Rating Scale
Subjective sound quality rating of streamed music using open domes
|
90 score on a scale
Interval 80.0 to 100.0
|
62.5 score on a scale
Interval 25.0 to 100.0
|
80 score on a scale
Interval 70.0 to 90.0
|
|
Sound Quality of Streamed Music Rating Scale
Subjective sound quality rating of streamed music using vented domes
|
94 score on a scale
Interval 84.0 to 100.0
|
81 score on a scale
Interval 50.0 to 100.0
|
90 score on a scale
Interval 80.0 to 100.0
|
PRIMARY outcome
Timeframe: 1 dayPopulation: All participants who rated sound quality of own voice using hearing aids with all three coupling systems.
subjective rating on a scale from 0 (worst) to 100 (best) for sound quality of participant's own voice quality.
Outcome measures
| Measure |
Custom Earmolds, Then Open Domes, Then Vented Domes
n=6 Participants
Participants first fit with Audeo 90P hearing aids and custom earmold with dynamic venting, then fit with the same hearing aids using open domes, then fit with the same hearing aids using vented domes.
|
Open Domes, Then Vented Domes, Then Custom Earmolds
n=6 Participants
Participants first fit with Audeo 90P hearing aids and open domes, then fit with the same hearing aids using vented domes, then fit with the same hearing aids using custom earmolds with dynamic venting.
|
Vented Domes, Then Custom Earmolds, Then Open Domes
n=2 Participants
Participants first fit with Audeo 90P hearing aids and vented domes, then fit with the same hearing aids using custom earmolds with dynamic venting, then fit with the same hearing aids using open domes.
|
|---|---|---|---|
|
Own Voice Sound Quality Rating Scale
Subjective rating of own voice sound quality using vented domes
|
85 score on a scale
Interval 75.0 to 100.0
|
73 score on a scale
Interval 40.0 to 100.0
|
65 score on a scale
Interval 55.0 to 75.0
|
|
Own Voice Sound Quality Rating Scale
Subjective rating of own voice using custom earmolds with dynamic venting
|
69.2 score on a scale
Interval 50.0 to 90.0
|
75 score on a scale
Interval 55.0 to 90.0
|
40 score on a scale
Interval 30.0 to 50.0
|
|
Own Voice Sound Quality Rating Scale
Subjective rating of own voice sound quality using open domes
|
80 score on a scale
Interval 63.0 to 98.0
|
78 score on a scale
Interval 50.0 to 100.0
|
50 score on a scale
Interval 25.0 to 75.0
|
Adverse Events
Participants Who Received Intervention of Custom Earmolds With Dynamic Venting
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Participants Who Received Intervention of Open Domes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Participants Who Received Intervention Vented Domes
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