Hearing Loss, Hearing Loss, Sensorineural
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICENew Receiver-in-Canal Device
Successor of previous device generation
DEVICELegacy Receiver-in-Canal Device
Receiver-in-canal device available on the market
Sponsors
Starkey Laboratories, Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Crossover Assignment - Each participant will experience both test conditions (counterbalanced)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults, minimum age of 18 * Native English speakers * Ability to complete questionnaires and laboratory assessments * Symmetric, mild to moderately-severe sensorineural hearing loss * Informed consent completed with signature
Exclusion criteria
* Inability to visit the Starkey Headquarters building for testing * Central or middle ear hearing problems * Medical contraindications to wearing hearing aids * Learning disability, major cognitive handicap, or serious neurological or psychiatric disease that would prevent or restrict participation, as determined by the PI or designee
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech intelligibility (% words repeated back correctly) in quiet and noise for new vs. legacy hearing aids | Four weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| First fit ratings of sound quality on subjective questionnaires for the new vs. legacy hearing aids | Four weeks | 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. |
| Safety of the new, receiver-in-canal devices through tracking of adverse events | Four weeks | This data will be collected through the tracking of adverse events. |
Countries
United States
Outcome results
None listed