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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05101083
• Other study ID #: PR 21001
• Status: Completed
• Phase: N/A
• Start date: October 25, 2021
• Est. completion date: January 10, 2022

Study information

• Verified date: January 2022
• Source: Starkey Laboratories, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 10, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Device:
• New Receiver-in-Canal Device
Successor of previous device generation
• Legacy Receiver-in-Canal Device
Receiver-in-canal device available on the market

Locations

Country	Name	City	State
United States	Starkey	Eden Prairie	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Starkey Laboratories, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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