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This clinical investigation is designed to compare audiological performance (i.e., measurements of sound quality and speech understanding) between Starkey's new receiver-in-canal device and a commercially available legacy receiver-in-canal device.
Starkey is investigating a new hearing aid with several new audiological features. These features have been assessed for benefit, individually, but this clinical investigation will serve as a test for safety and efficacy with all hearing aid features, together. The design of this study is a single-blinded, crossover design and will be conducted at Starkey's headquarters in Eden Prairie, MN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hearing Aid 1 | Experimental | New Receiver-in-Canal device, successor of previous device generation |
|
| Hearing Aid 2 | Active Comparator | Legacy Receiver-in-Canal device that is currently available on the market |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New Receiver-in-Canal Device | Device | Successor of previous device generation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Speech intelligibility (% words repeated back correctly) in quiet and noise for new vs. legacy hearing aids | IEEE sentences will be presented to the research participants in quiet and in background noise. The percent words repeated back correctly will be scored and serve as the reported result of this outcome measure. | Four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| First fit ratings of sound quality on subjective questionnaires for the new vs. legacy hearing aids | This data will be collected through lab testing following the first fit of the hearing aids. Participants will answer questionnaire items related to their impressions of sound quality. Results will be collected using a 7-point Likert scale, and ratings (1-7) will be analyzed using descriptive statistics. Statistical measures for repeated measurements will be used to understand any differences between hearing aid conditions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Starkey | Eden Prairie | Minnesota | 55344 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 25, 2023 | May 22, 2023 | 3 |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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Crossover Assignment - Each participant will experience both test conditions (counterbalanced)
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| Legacy Receiver-in-Canal Device |
| Device |
Receiver-in-canal device available on the market |
|
| Four weeks |
| Safety of the new, receiver-in-canal devices through tracking of adverse events | This data will be collected through the tracking of adverse events. | Four weeks |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |