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NCT Number: NCT07489807

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

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).

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hearing Aid with NR_4

Device

Amplification of approx. 8dB from 1 Hz to 8 kHz. No noise cancellation activated

Primary outcomes

  1. Tinnitus Functional Index

    Time frame: 3 weeks

    Questionnaire assessing tinnitus related distress, consisting on 25 questions that can be answered with likert scale from 0 to 10 where 10 is the most extreme negative value

Secondary outcomes

  1. Tinnitus loudness

    Time frame: 3 weeks

    Psychoacoustic measurement where participants match the loudness of their tinnitus to either a pure-tone or noisy sound. The loudness of the matched tone could be changed in 3 decibel steps.

  2. Tinnitus spectrum

    Time frame: 3 weeks

    It was based on the method described by Noreña et al. (2002). The stimuli consisted of either 2-second pure tones (first condition) or 2-second one-third octave noise bands (second condition), with center frequencies spanning from 125 Hz to 14 kHz. These sounds were delivered monaurally through headphones to the ear in which tinnitus was perceived as most intense. When tinnitus perception was equal in both ears, stimulation was applied to the ear with the lower average thresholds at high frequencies. All stimuli were presented at an intensity corresponding to the loudness match of a 1 kHz pure tone, but never below 10 dB sensation level (SL).

  3. Visual Analog Scale - annoyance

    Time frame: 3 weeks

    Likert scale from 0-10 where 0 = "My tinnitus is not annoying" and 10 = "My tinnitus is extremely annoying"

  4. Visual Analog Scale - loudness

    Time frame: 3 weeks

    Likert scale from 0-10 where 0 = "I cannot hear my tinnitus" and 10 = "My tinnitus is extremely loud"

Sponsors and collaborators

Lead sponsor

Technical University of Denmark

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 24, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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