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

Part of paid clinical trials in Broomfield, Colorado.

Sponsor
Starkey Laboratories, Inc
Study ID
NCT07298499
Status
Enrolling By Invitation

Conditions

  • Hearing Aid
  • Tinnitus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Hearing Aid — DEVICE
    Inclusion of hearing aid or not for listening
  • Tinnitus Masker — DEVICE
    Inclusion of tinnitus masker in device

Study Details

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.

Key Dates

Start date
Jul 7, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Amplification with or without masker
    Amplification alone or amplification plus tinnitus masker

Primary Outcome Measure

Provision of adequate amplification [ Time Frame: The time frame of this data collection is at the hearing aid fitting which occurs at the initial fitting (Session 1, day 1). This will occur the first time the participant is seen for the study visits. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Starkey Satellite Research Facility Affordable Hearing Centers 6821 W 120th Ave Ste 2H, Broomfield, CO 80020BroomfieldColorado80020-

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

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