RecruitingNot ApplicableNCT07489807

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


Sponsor

Technical University of Denmark

Enrollment

15 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria3

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

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Interventions

DEVICEHearing Aid with NR_4

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


Locations(1)

Hearing Systems Section

Lyngby, Denmark

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NCT07489807


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