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Hearing aids and a tinnitus masker for hearing loss with tinnitus

Tests hearing aids and a tinnitus masker in adults with tinnitus.

Key facts

Who runs it
Starkey Laboratories, Inc
Where
Broomfield, United StatesSee the site
Trial code
Registry title
Amplification and Tinnitus Masker Performance and Benefit for Adults With Hearing Loss and Tinnitus
Status
Enrolling by invitation
People taking part
100 people, planned
Started
7 Jul 2025
Expected to end
Dec 2027
Type of study
Interventional
Treatments tested
  • Hearing Aid
  • Tinnitus Masker
Record updated
31 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with hearing loss in both ears and tinnitus (ringing in the ears). They will test hearing aids for 6 months, with a tinnitus sound masker added at 3 months.

Age
18 years and older
Sex
All sexes
Disease stage
Hearing loss in both ears, from mild to profound. Tinnitus from mild to severe.
Earlier treatment
People who already use a wearable noise masker cannot join.
Biomarker or test result
Hearing tests: an air-bone gap of 15 dB or more at 500 Hz, 1000 Hz and 2000 Hz excludes you.

Main reasons for not taking part

  • Hearing loss or tinnitus in only one ear, or a clear difference between ears
  • Sudden, quickly worsening or changing hearing loss within the previous 6 months
  • Ear deformity, ear pain, or fluid, pus or blood from the ear within the previous 6 months
  • Dizziness, cognitive impairment, or extreme sensitivity to sounds (hyperacusis)
  • Not a native English speaker, or employed by the study sponsor

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • At least 18 years old; Native English speaking (defined that all education was done in English); Bilateral hearing impairment ranging from mild to profound; Mild to severe tinnitus; Ability to commute to research facility

Who cannot take part

  • Participants will be advised to consult promptly a doctor, preferably an ear specialist such as an ENT, prior to being fit with the study devices, if they display any of the following conditions:; Visible deformity of the ear, either congenital or traumatic; Fluid, pus, or blood coming out of the ear within the previous 6 months; Pain or discomfort in the ear; History of excessive ear wax or suspicion that something is in the ear canal; Dizziness, either recent or long-standing; Sudden, quickly worsening, or fluctuating hearing loss within the previous 6 months; Hearing loss or ringing (tinnitus) only in one ear or a noticeable difference in hearing between ears; Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz, and 2000 Hz; Cognitive impairment; Tinnitus with a somatic origin indicating a need for medical treatment; Current user of noise masker delivered via a wearable device; Hyperacusis or extreme sensitivity to sounds; Is employed by the study sponsor

Where in United States

  • Starkey Satellite Research Facility Affordable Hearing Centers 6821 W 120th Ave Ste 2H, Broomfield, CO 80020Broomfield, United StatesEnrolling by invitation

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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.

The group in the trial

  • Amplification with or without maskerTreatment being tested

    Amplification alone or amplification plus tinnitus masker

    Treatment: Hearing Aid and Tinnitus Masker

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Post-Market Clinical Follow-Up of Hearing Aids and Tinnitus Masker Technology
Plain-language title
Hearing aids and a tinnitus masker for hearing loss with tinnitusGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
31 December 2025