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 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.
Highlights
IntroductionRegardless of the initial injury associated with tinnitus onset (e.g., cochlear damage), the continued perception of tinnitus is generated by neural activity within the central auditory system (Eggermont, 2003)
Research has shown that, regardless of the initial injury associated with tinnitus onset, the continued perception of tinnitus is generated by neural activity within the central auditory system (Eggermont, 2003)
This study offers some support for greater average improvement in reactions to tinnitus with TM or noise stimulus (NS) devices compared to the bedside sound generator (BSG) device
Summary
Regardless of the initial injury associated with tinnitus onset (e.g., cochlear damage), the continued perception of tinnitus is generated by neural activity within the central auditory system (Eggermont, 2003). One rationale for using sound stimulation is to induce neural plastic changes in the central auditory system to counteract the maladaptive changes thought to be linked to the tinnitus percept (Shore, Roberts, & Langguth, 2016). This study provided the basis for the development of a commercially available product that was designed and manufactured by the Otoharmonics Corporation (Levo System, version 2.2.6)
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