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

American Journal of Audiology
Sarah TheodoroffJames A Henry

Abstract

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 ...Continue Reading

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Citations

Feb 7, 2018·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Kathleen C M Campbell, Colleen G Le Prell
Dec 28, 2018·The Cochrane Database of Systematic Reviews·Magdalena SeredaDerek J Hoare
Apr 26, 2019·American Journal of Audiology·Sarah M Theodoroff, James A Kaltenbach
Apr 26, 2019·American Journal of Audiology·James A Henry, Candice Manning
Nov 7, 2019·American Journal of Audiology·James A HenryPhilippe Fournier
Sep 26, 2020·Therapeutic Advances in Chronic Disease·Haiyan WangShan Sun
Sep 10, 2019·International Journal of Audiology·Adam SheppardRichard Salvi
Oct 9, 2020·The Annals of Otology, Rhinology, and Laryngology·Mehdi AbouzariHamid R Djalilian
Sep 23, 2021·International Journal of Audiology·Aniruddha K DeshpandeChanapong Rojanaworarit
Sep 24, 2020·ORL; Journal for Oto-rhino-laryngology and Its Related Specialties·Huseyin DenizElif Tugba Sarac
Dec 2, 2021·International Journal of Audiology·Sarah M TheodoroffJames A Henry

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