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Sound therapy shows promise for ringing ears in veterans

NCT ID NCT04661995

Symptom relief Sponsor: VA Office of Research and Development 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 15, 2026 · Updated 3 times

Summary

This completed study tested a sound-based therapy for tinnitus (ringing in the ears) in 108 Veterans. Participants used hearing aids that played either notched noise (sound with the tinnitus frequency removed) or broadband white noise. The goal was to see if notched noise could reduce tinnitus loudness and its impact on daily life over 12 weeks. Results could help improve sound-based treatments for this common problem.

What this could mean

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

Active substance
Notched noise therapy delivered through hearing aids
What this could lead to
If it works, this could point toward a non-drug, sound-based treatment to ease the ringing of tinnitus for Veterans and others.
What could go wrong
This is a completed trial with 108 participants, but results are not yet widely confirmed. The therapy may not work for everyone, and benefits could be small or temporary.

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

108 people

The number who actually took part.

Started

Mar 2023

Finished

May 2026

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: Candidates must meet the following inclusion criteria to qualify: * Veteran * no active middle-ear disease * at least one air conduction hearing threshold of 40 dB HL or worse in each ear between .25-8 kHz as measured at the first study visit * unilateral or bilateral constant tinnitus * index score on the Tinnitus Functional Index (TFI) of at least 25 (out of a maximum score of 100) * a score of 24 or higher on the Mini Mental State Exam (MMSE) * a tinnitus pitch match between 2-10 kHz (and achieve desired level of precision as described below in 3.3 Study Procedures, Tinnitus Psychoacoustic Assessment) * demonstrates understanding of the requirements of the study * motivated and capable of participating (including ability to communicate in English) Exclusion Criteria: The following exclusion criteria will be used: * two or more hearing thresholds exceeding 70 dB HL * significant conductive hearing loss-defined as an air-bone gap of 15 dB at more than two frequencies in one ear, or an air-bone gap greater than 15 dB at any one frequency * suspicion of secondary (somatic) tinnitus, Meniere's disease, or tinnitus potentially related to temporo-mandibular disorder or whiplash (any of which can be ruled out with an examination by an appropriate physician) * any mental, emotional, or health conditions that would preclude full study participation

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Conditions

The condition(s) this trial relates to.

tinnitus

As listed by the trial registrant

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

Notched noise therapy Tinnitus

Contacts and locations

Locations

  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina, 27705-3875, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.