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* The effect of broadband amplification was tested in a double-blinded crossover study * Its effect was compared to an active placebo treatment * An improvement in tinnitus distress was found after use of broadband amplification * No effect was found on the tinnitus loudness
This study investigated the effect of broadband amplification (125 Hz to 10 kHz) as tinnitus treatment for participants with high-frequency hearing loss and compared these effects with an active placebo condition using band-limited amplification (125 Hz to 3-4 kHz). A double-blinded crossover study. 23 participants with a high-frequency (≥ 3 kHz) hearing loss and chronic tinnitus were included in the study and 17 completed the full treatment protocol. Two different hearing aid treatments were provided for 3 months each: broadband amplification that provided gain in the frequency range from 125 Hz to 10 kHz and band-limited amplification that only provided gain in the low frequency range (≤ 3-4 kHz). The effect of the two treatments on tinnitus distress was evaluated with the Tinnitus Handicap Inventory (THI) and the Tinnitus Functional Index (TFI) questionnaires. The effect of the treatment on tinnitus loudness was evaluated with a visual analog scale (VAS) for loudness and a psychoacoustic loudness measure. Furthermore, the tinnitus annoyance was evaluated with a VAS for annoyance. The tinnitus pitch was evaluated based on the tinnitus likeness spectrum.
Age
18 - 90 years
Sex
ALL
Healthy Volunteers
No
Technical University of Denmark
Kongens Lyngby, Denmark
Start Date
May 1, 2019
Primary Completion Date
February 28, 2021
Completion Date
February 28, 2021
Last Updated
April 10, 2024
23
ACTUAL participants
Broadband amplification from hearing aids
DEVICE
Band-limited amplification from hearing aids
DEVICE
Lead Sponsor
Technical University of Denmark
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07468318