Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Mild 8 dB hearing amplification for tinnitus in adults with normal hearing

Official title: The Effect of Mild-gain Amplification on Tinnitus Perception in Normal Hearing Adults

Run by Technical University of Denmark · NCT07489807 · Data updated 2026-11-12

This test tries wearing hearing aids that add a small (8 dB) boost to see if they reduce tinnitus symptoms in adults with normal hearing.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment15 (estimated)
SponsorTechnical University of Denmark
Academic / other
Locations1 site (Lyngby)
StatusRecruiting
StartedApril 1, 2025
Main results expectedAugust 1, 2026
Study endsJune 1, 2027
Registry record updatedMarch 31, 2026
Trial IDNCT07489807 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with chronic bothersome subjective tinnitus for at least three months, normal hearing thresholds (≤25 dB HL from 125 Hz to 8 kHz), and no prior hearing-aid experience are the ideal candidates.

Probably not a fit

People with objective or pulsatile tinnitus, Meniere's disease, a history of stapedectomy/stapedotomy/tympanoplasty, or hearing loss >25 dB HL are unlikely to benefit from this specific approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This double-blinded crossover study enrolled 12 adults with chronic, bothersome tinnitus and normal audiograms to compare two hearing-aid settings delivered for three weeks each. One condition provided a mild 8 dB gain from 1 Hz to 8 kHz and the other provided no amplification as an active placebo. Outcomes included changes in tinnitus-related distress measured by the Tinnitus Functional Index (TFI) and ratings of tinnitus loudness and annoyance on visual analog scales (VAS). Participants were inexperienced hearing-aid users and were screened to exclude objective/pulsatile tinnitus and certain middle-ear disorders.

Why it matters

Potential benefit: If successful, mild-gain amplification via hearing aids could reduce tinnitus distress, perceived loudness, and annoyance for some adults with normal hearing.

How similar studies have gone: Hearing-aid amplification has shown benefit for tinnitus in people with hearing loss, but using a mild 8 dB gain in people with strictly normal hearing is less well studied and evidence is limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Daily bothersome tinnitus for at least 3 months (TFI\>15)
* Normal hearing (25 dB HL from 125 Hz to 8 kHz)
* Inexperienced hearing aid user

Exclusion Criteria:

* Meniere's disease, Tosclerosis, Stapedectomy, Stapedotomy and Tympanoplasty
* Objective or pulsatile tinnitus
* Hearing thresholds \>25 dB from 125 Hz to 8 kHz

Where it's running

  • Hearing Systems Section
    Lyngby, Denmark
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.