Speech Intelligibility in Quiet and Noise for New vs. Legacy Hearing Aids

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Speech Intelligibility in Quiet and Noise for New Versus Legacy Hearing Aids

Conditions
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Hearing Loss, Sensorineural, Hearing Loss

Intervention / Treatment
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* Device: New Receiver-in-Canal Device
* Device: Legacy Receiver-in-Canal Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover Assignment - Each participant will experience both test conditions (counterbalanced)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hearing Aid 1<br>New Receiver-in-Canal device, successor of previous device generation | Device: Legacy Receiver-in-Canal Device<br>* Receiver-in-canal device available on the market<br>|
| Active Comparator: Hearing Aid 2<br>Legacy Receiver-in-Canal device that is currently available on the market | Device: New Receiver-in-Canal Device<br>* Successor of previous device generation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |