Speech Intelligibility in Quiet and Noise for New Versus Legacy Hearing Aids
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hearing Loss, Sensorineural
- Sponsor
- Starkey Laboratories, Inc
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Speech intelligibility (% words repeated back correctly) in quiet and noise for new vs. legacy hearing aids
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Speech intelligibility (% words repeated back correctly) in quiet and noise for new vs. legacy hearing aids
Time Frame: 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 Outcomes
- First fit ratings of sound quality on subjective questionnaires for the new vs. legacy hearing aids(Four weeks)
- Safety of the new, receiver-in-canal devices through tracking of adverse events(Four weeks)