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ENROLLING BY INVITATION
NCT07298499
NA

Amplification and Tinnitus Masker Performance and Benefit for Adults With Hearing Loss and Tinnitus

Sponsor: Starkey Laboratories, Inc

View on ClinicalTrials.gov

Summary

This study is a Post-Market Clinical Investigation whose primary purpose is to evaluate hearing aid amplification and tinnitus masker performance for individuals with hearing loss and tinnitus. There are two primary hypotheses that will be assessed in this study: The use of well-fit amplification alone improves participants' ability to hear and improves tinnitus symptoms as compared to unaided conditions. The use of well-fit amplification in conjunction with a tinnitus masker improves participants' ability to hear and improves tinnitus symptoms as compared to unaided conditions. Participants will be fit with hearing aids for 6 months and a tinnitus masker will be activated at the 3-month mark of the study. Outcome measures will evaluate device performance and participant benefit from the devices throughout the study duration.

Official title: Post-Market Clinical Follow-Up of Hearing Aids and Tinnitus Masker Technology

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-07-07

Completion Date

2027-12

Last Updated

2025-12-31

Healthy Volunteers

Yes

Interventions

DEVICE

Hearing Aid

Inclusion of hearing aid or not for listening

DEVICE

Tinnitus Masker

Inclusion of tinnitus masker in device

Locations (1)

Starkey Satellite Research Facility Affordable Hearing Centers 6821 W 120th Ave Ste 2H, Broomfield, CO 80020

Broomfield, Colorado, United States