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

NCT07298499 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-31

No results posted yet for this study

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.

Conditions

  • Hearing Aid
  • Tinnitus

Interventions

DEVICE

Hearing Aid

Inclusion of hearing aid or not for listening

DEVICE

Tinnitus Masker

Inclusion of tinnitus masker in device

Sponsors & Collaborators

  • Starkey Laboratories, Inc

    lead INDUSTRY

Principal Investigators

  • Michelle Hicks, Ph.D. · VP Education and Audiology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-07
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07298499 on ClinicalTrials.gov