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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Hearing Systems Section
RECRUITING
Lyngby
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 15
Treatments
Experimental: Experimental: mild gain amplification: (8dB, 1 Hz to 8 kHz)
Device: mild gain amplification from hearing aids Amplification of 8dB from 1 Hz to 8 kHz No noise cancelling activated
Placebo_comparator: Placebo Comparator: no amplification
Device: hearing aids with no amplification. No noise cancelling activated
Related Therapeutic Areas
Sponsors
Leads: Technical University of Denmark

This content was sourced from clinicaltrials.gov