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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Tinnitus

In brief

This study investigated the effect of mild gain amplification (8dB covering 1 Hz to 8kHz) as tinnitus treatment for participants with normal hearing and compared these effects with an active placebo condition using hearing aids without amplification in a double-blinded crossover study. 12 participants with normal hearing and chronic tinnitus were included in the study. Two different hearing aid treatments were provided for 3 weeks each: mild gain amplification that provided 8dB gain in the frequency range from 1 Hz to 8 kHz and no amplification, acting as placebo. The effect of the two treatments on tinnitus distress was evaluated with the Tinnitus Functional Index (TFI) questionnaire. The effect of the treatment on tinnitus loudness and annoyance were evaluated with a visual analog scale (VAS).

Key facts

Study ID

NCT07489807

Run by

Technical University of Denmark

People needed

15

Starts

2025-04-01

Expected to finish

2027-06-01

Last updated by the study team

2026-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Hearing Systems Section — Lyngby, Denmark (enrolling)

Full record on ClinicalTrials.gov

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