Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07489807

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

Led by Technical University of Denmark · Updated on 2026-03-31

15

Participants Needed

1

Research Sites

113 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Daily bothersome tinnitus for at least 3 months with Tinnitus Functional Index greater than 15
  • Normal hearing with hearing thresholds of 25 dB HL or better from 125 Hz to 8 kHz
  • Inexperienced hearing aid user
Not Eligible

You will not qualify if you...

  • Diagnosis of Meniere's disease, otosclerosis, stapedectomy, stapedotomy, or tympanoplasty
  • Presence of objective or pulsatile tinnitus
  • Hearing thresholds worse than 25 dB HL from 125 Hz to 8 kHz

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hearing Systems Section

Lyngby, Denmark

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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