Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Custom earmolds, then Open domes, then Vented domes | Experimental | Participants first fit with Audeo 90P hearing aids and custom earmolds 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 | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Audeo P90 hearing aid with custom earmolds using dynamic venting | Device | Audeo P90 hearing aids coupled to custom earmolds that use dynamic venting. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sound Quality of Streamed Music Rating Scale | subjective rating on scale from 0 (worst) to 100 (best) for sound quality of streamed signal | 1 day |
| 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. | 1 day |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
-
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sonova US | Aurora | Illinois | 60504 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
|
| ||||||||||||||||||
| Second Intervention |
| |||||||||||||||||||
| Third Intervention |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sound Quality of Streamed Music Rating Scale | subjective rating on scale from 0 (worst) to 100 (best) for sound quality of streamed signal | All participants who evaluated the sound quality of streamed music using all three coupling systems. | Posted | Mean | Full Range | score on a scale | 1 day |
|
Two separate appointments, one day each, for a total of two non-consecutive days.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants Who Received Intervention of Custom Earmolds With Dynamic Venting | All participants who received the intervention of custom earmolds with dynamic venting. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Sonova USCS | 630-821-5000 | phonakaudiologyresearch@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2023 | May 12, 2023 | Prot_SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Audeo P90 hearing aid with Open domes | Device | Audeo P90 hearing aid coupled with non-custom, manufacturer open domes |
|
| Audeo P90 hearing aid with Vented domes | Device | Audeo P90 hearing aid coupled with non-custom, manufacturer vented domes |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Mild to moderate hearing loss | Count of Participants | Participants |
|
| OG002 | 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. |
|
|
|
| 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. | All participants who rated sound quality of own voice using hearing aids with all three coupling systems. | Posted | Mean | Full Range | score on a scale | 1 day |
|
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Participants Who Received Intervention of Open Domes | All participants who received the intervention of open domes. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG002 | Participants Who Received Intervention Vented Domes | All participants who received the intervention of vented domes. | 0 | 17 | 0 | 17 | 0 | 17 |
Not provided
Not provided
Not provided
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Subjective rating of own voice sound quality using open domes |
|
| Subjective rating of own voice sound quality using vented domes |
|