Randomized Controlled Trial of a Novel Device for Tinnitus Sound Therapy During Sleep

The aim of this study was to determine if a customized stimulus from the Otoharmonics Levo System reduces tinnitus perceptions and reactions for people with bothersome tinnitus. Sixty participants were randomized to 1 of 3 groups that used sound therapy devices during sleep that differed in their ac...

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Bibliographic Details
Published in:American journal of audiology 2017-12, Vol.26 (4), p.543-554
Main Authors: Theodoroff, Sarah M, McMillan, Garnett P, Zaugg, Tara L, Cheslock, Megan, Roberts, Chan, Henry, James A
Format: Article
Language:English
Subjects:
Acoustics
Analysis
Auditory perception
Care and treatment
Clinical trials
Evidence-based medicine
Health aspects
Hearing disorders
Hearing loss
Information Processing
Informed Consent
Measures
Music therapy
Noise
Outcome Measures
Perceptions
Quality of life
Randomized Controlled Trials
Rating Scales
Screening Tests
Sleep
Sound intensity
Sound therapy
Therapy
Tinnitus
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Summary:The aim of this study was to determine if a customized stimulus from the Otoharmonics Levo System reduces tinnitus perceptions and reactions for people with bothersome tinnitus. Sixty participants were randomized to 1 of 3 groups that used sound therapy devices during sleep that differed in their acoustic stimulus: (a) tinnitus-matched (TM), (b) noise stimulus (NS), and (c) bedside sound generator (BSG). Outcome measures were the Tinnitus Functional Index (TFI), numeric rating scale of tinnitus loudness, and tinnitus loudness match. A Bayesian hierarchical model was fit to estimate the differences in treatment efficacy among groups. Average tinnitus reactions and perceptions improved across treatment groups. We are at least 87% certain that treatment with TM or NS reduces mean TFI compared to treatment with BSG, with an estimated relative efficacy of 4.5-5 points greater reduction. We are at least 95% certain that treatment with TM results in greater reduction in mean numeric rating scale (NRS) of tinnitus loudness compared to the other groups, with an estimated relative efficacy of about 0.75 points greater reduction. This study offers some support for greater average improvement in reactions to tinnitus with TM or NS devices compared to the BSG device. The TM group, compared to the BSG and NS groups, showed a greater reduction in ratings of tinnitus loudness on the NRS on average. https://doi.org/10.23641/asha.5545759.
ISSN:1059-0889
1558-9137
DOI:10.1044/2017_AJA-17-0022