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Can hearing aids and tinnitus maskers silence the ringing?

NCT ID NCT07298499

Symptom relief Sponsor: Starkey Laboratories, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether hearing aids alone or hearing aids with a tinnitus masker can improve hearing and reduce tinnitus symptoms in adults with hearing loss and tinnitus. One hundred participants will wear hearing aids for 6 months, with the masker turned on after 3 months. Researchers will measure hearing ability, satisfaction, and tinnitus impact using questionnaires and ear exams.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hearing aid and tinnitus masker device
What this could lead to
If successful, this could confirm that combining hearing aids with a tinnitus masker provides better hearing and tinnitus relief than hearing aids alone.
What could go wrong
This is a post-market study with only 100 participants, so results may not apply to everyone. The devices may cause minor skin irritation or not improve symptoms for some users.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

hearing loss disorder tinnitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hearing aid Tinnitus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    Broomfield, Colorado, 80020, United States

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