NCT07489807

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Technical University of Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Tinnitus

Interventions

Type	Name	Description
DEVICE	Hearing Aid with NR_4	Amplification of approx. 8dB from 1 Hz to 8 kHz. No noise cancellation activated

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-08-01
• Completion: 2027-06-01
• First posted: 2026-03-24
• Last updated: 2026-03-31

Locations

1 site across 1 country: Denmark