The results of a three month study conducted by the Department of Veterans Affairs (VA) can be found below:
Randomized Controlled Trial of a Novel Device for Tinnitus Sound Therapy During Sleep
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 https://doi.org/10.23641/asha.5545759
Tinnitus is the perception of sound that has no source outside of the head. It is most typically associated with exposure to loud noise, which can also cause hearing loss (Axelsson & Barrenäs, 1992; Penner & Bilger, 1995). A direct correlation exists between degree of hearing loss and prevalence of tinnitus—the likelihood of incurring tinnitus increases with a greater degree of hearing loss (Coles, 2000). In general, tinnitus can occur as the result of noise damage, blast exposures, head and neck trauma or pathology, drugs or medications, and other medical conditions (e.g., acoustic neuroma, cardiovascular and cerebrovascular disease, hyper- and hypothyroidism; Hoffman & Reed, 2004; Meikle, Creedon, & Griest, 2004). Tinnitus can result in psychological reactions (e.g., anxiety, sadness, distress), attention and concentration difficulties, problems with sleeping, and overall reduced quality of life (Cima, Crombez, & Vlaeyen, 2011; Crönlein et al., 2016; Dobie, 2003; Erlandsson & Hallberg, 2000).