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AJA-17-0022theodoroff_SuppS1.pdf (119.86 kB)

Tinnitus sound therapy during sleep (Theodoroff et al., 2017)

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posted on 2017-10-31, 22:16 authored by Sarah M. Theodoroff, Garnett P. McMillan, Tara L. Zaugg, Megan Cheslock, Chan Roberts, James A. Henry
Purpose: 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.
Method: 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.
Results: 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.
Conclusions: 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.

Supplemental Material S1. Raw data and model-fitting code.

Theodoroff, S. M., McMillan, G. P., Zaugg, T. L., Cheslock, M., Roberts, C., & Henry, J. A. (2017). Randomized controlled yrial of a novel device for tinnitus sound therapy during sleep. American Journal of Audiology, 26, 543–554.


This research was funded by the Baker Group, LLP, who manufactured the Levo System device (Portland VA Research Foundation 387004), and by the Department of Veterans Affairs, Rehabilitation Research & Development Service by a Program Award to the National Center for Rehabilitative Auditory Research (C9230C) and by a research career scientist award granted to Dr. James A. Henry (C9247S) at the VA Portland Health Care System in Portland, Oregon.


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