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Amplification and Tinnitus Masker Performance and Benefit for Adults With Hearing Loss and Tinnitus
Sponsor: Starkey Laboratories, Inc
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
Conditions
Interventions
Hearing Aid
Inclusion of hearing aid or not for listening
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