Hearing Loss, Sensorineural
Conditions
Brief summary
Participants will be comparing the sound quality of their own voice and the sound quality of streamed music using universal couplings and a custom earmold with a dynamic vent.
Interventions
DEVICEAudeo P90 hearing aid with custom earmolds using dynamic venting
Audeo P90 hearing aids coupled to custom earmolds that use dynamic venting.
DEVICEAudeo P90 hearing aid with Open domes
Audeo P90 hearing aid coupled with non-custom, manufacturer open domes
DEVICEAudeo P90 hearing aid with Vented domes
Audeo P90 hearing aid coupled with non-custom, manufacturer vented domes
Sponsors
Sonova AG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Mild to severe bilateral sensorineural hearing loss * hearing must be symmetrical below 500 Hz * must live within 30 miles of Aurora IL
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sound Quality of Streamed Music Rating Scale | 1 day | subjective rating on scale from 0 (worst) to 100 (best) for sound quality of streamed signal |
| Own Voice Sound Quality Rating Scale | 1 day | subjective rating on a scale from 0 (worst) to 100 (best) for sound quality of participant's own voice quality. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Group 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. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| First Intervention | Physician Decision | 0 | 0 | 3 |
Baseline characteristics
| Characteristic | Study Group | — |
|---|---|---|
| Age, Continuous | 71 years | — |
| Mild to moderate hearing loss | 14 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 14 participants | — |
| Sex: Female, Male Female | 6 Participants | — |
| Sex: Female, Male Male | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 | 0 / 17 |
| other Total, other adverse events | 0 / 14 | 0 / 14 | 0 / 17 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 | 0 / 17 |
Outcome results
Primary
Own Voice Sound Quality Rating Scale
subjective rating on a scale from 0 (worst) to 100 (best) for sound quality of participant's own voice quality.
Time frame: 1 day
Population: All participants who rated sound quality of own voice using hearing aids with all three coupling systems.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Custom Earmolds, Then Open Domes, Then Vented Domes | Own Voice Sound Quality Rating Scale | Subjective rating of own voice sound quality using vented domes | 85 score on a scale |
| Custom Earmolds, Then Open Domes, Then Vented Domes | Own Voice Sound Quality Rating Scale | Subjective rating of own voice sound quality using open domes | 80 score on a scale |
| Custom Earmolds, Then Open Domes, Then Vented Domes | Own Voice Sound Quality Rating Scale | Subjective rating of own voice using custom earmolds with dynamic venting | 69.2 score on a scale |
| Open Domes, Then Vented Domes, Then Custom Earmolds | Own Voice Sound Quality Rating Scale | Subjective rating of own voice sound quality using vented domes | 73 score on a scale |
| Open Domes, Then Vented Domes, Then Custom Earmolds | Own Voice Sound Quality Rating Scale | Subjective rating of own voice using custom earmolds with dynamic venting | 75 score on a scale |
| Open Domes, Then Vented Domes, Then Custom Earmolds | Own Voice Sound Quality Rating Scale | Subjective rating of own voice sound quality using open domes | 78 score on a scale |
| Vented Domes, Then Custom Earmolds, Then Open Domes | Own Voice Sound Quality Rating Scale | Subjective rating of own voice sound quality using open domes | 50 score on a scale |
| Vented Domes, Then Custom Earmolds, Then Open Domes | Own Voice Sound Quality Rating Scale | Subjective rating of own voice using custom earmolds with dynamic venting | 40 score on a scale |
| Vented Domes, Then Custom Earmolds, Then Open Domes | Own Voice Sound Quality Rating Scale | Subjective rating of own voice sound quality using vented domes | 65 score on a scale |
Comparison: Treatment order was not analyzed. A repeated measures ANOVA was performed to compare the effect of the coupling conditions on sound quality ratings for own voice, but there was no analysis between groups.p-value: 0.154ANOVA
Primary
Sound Quality of Streamed Music Rating Scale
subjective rating on scale from 0 (worst) to 100 (best) for sound quality of streamed signal
Time frame: 1 day
Population: All participants who evaluated the sound quality of streamed music using all three coupling systems.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Custom Earmolds, Then Open Domes, Then Vented Domes | Sound Quality of Streamed Music Rating Scale | Subjective sound quality rating of streamed music using open domes | 90 score on a scale |
| Custom Earmolds, Then Open Domes, Then Vented Domes | Sound Quality of Streamed Music Rating Scale | Subjective sound quality rating of streamed music with custom earmolds | 84 score on a scale |
| Custom Earmolds, Then Open Domes, Then Vented Domes | Sound Quality of Streamed Music Rating Scale | Subjective sound quality rating of streamed music using vented domes | 94 score on a scale |
| Open Domes, Then Vented Domes, Then Custom Earmolds | Sound Quality of Streamed Music Rating Scale | Subjective sound quality rating of streamed music using open domes | 62.5 score on a scale |
| Open Domes, Then Vented Domes, Then Custom Earmolds | Sound Quality of Streamed Music Rating Scale | Subjective sound quality rating of streamed music using vented domes | 81 score on a scale |
| Open Domes, Then Vented Domes, Then Custom Earmolds | Sound Quality of Streamed Music Rating Scale | Subjective sound quality rating of streamed music with custom earmolds | 70 score on a scale |
| Vented Domes, Then Custom Earmolds, Then Open Domes | Sound Quality of Streamed Music Rating Scale | Subjective sound quality rating of streamed music with custom earmolds | 70 score on a scale |
| Vented Domes, Then Custom Earmolds, Then Open Domes | Sound Quality of Streamed Music Rating Scale | Subjective sound quality rating of streamed music using open domes | 80 score on a scale |
| Vented Domes, Then Custom Earmolds, Then Open Domes | Sound Quality of Streamed Music Rating Scale | Subjective sound quality rating of streamed music using vented domes | 90 score on a scale |
Comparison: Treatment order was not analyzed. A repeated measures ANOVA was performed to compare the effect of the coupling conditions on sound quality ratings for streamed music, but there was no analysis between groups.p-value: 0.012ANOVA