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

Not Applicable

Completed

• Conditions: Hearing Loss; Hearing Loss, Sensorineural
• Interventions: Device: Legacy Receiver-in-Canal Device; Device: New Receiver-in-Canal Device

• Registration Number: NCT05101083
• Lead Sponsor: Starkey Laboratories, Inc

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.

Study Timeline

• Study First Submitted: 2021-10-18
• Study Start: 2021-10-25
• Study First Submitted QC: 2021-10-28
• Study First Posted: 2021-11-01
• Status Verified: 2022-01
• Primary Completion: 2022-01-10
• Study Completion: 2022-01-10
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hearing Aid 1	Legacy Receiver-in-Canal Device	New Receiver-in-Canal device, successor of previous device generation
Hearing Aid 2	New Receiver-in-Canal Device	Legacy Receiver-in-Canal device that is currently available on the market

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Starkey; 🇺🇸 Eden Prairie, Minnesota, United States