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

Manganese and Lipoflavonoid Plus® to Treat Tinnitus: A Randomized Controlled Trial

Background: Several tinnitus sufferers suggest that manganese has been helpful with their tinnitus. Purpose: We tested this in a controlled experiment where participants were committed to taking manganese and Lipoflavonoid Plus® to treat their tinnitus. Research Design: Randomized controlled trial. Study Sample: 40 participants were randomized to receive both manganese and Lipoflavonoid Plus® for 6 months, or Lipoflavonoid Plus® only (as the control). Data Collection and Analysis: Pre- and postmeasures were obtained with the Tinnitus Handicap Questionnaire, Tinnitus Primary Functions Questionnaire, and tinnitus loudness and annoyance ratings. An audiologist performed the audiogram, the tinnitus loudness match, and minimal masking level. Results: Twelve participants were dropped out of the study because of the side effects or were lost to follow-up. In the manganese group, 1 participant (out of 12) showed a decrease in the questionnaires, and another showed a decrease in the loudness and annoyance ratings. No participants from the control group (total 16) showed a decrease in the questionnaires ratings. Two participants in the control group reported a loudness decrement and one reported an annoyance decrement. Conclusions: We were not able to conclude that either manganese or Lipoflavonoid Plus® is an effective treatment for tinnitus.

Client centred hypnotherapy in the management of tinnitus – is it better than counselling?

The aim of this study was to assess whether client centred hypnotherapy (CCH) which required three sessions with a trained therapist was superior to a single counselling session in reducing the impact of tinnitus.Patients were randomly allocated to receive either counselling (n = 42) or CCH (n = 44). The outcome measures were: tinnitus loudness match, subjective tinnitus symptom severity score, trend of linear analogue scale, request for further therapy and whether the patient had an impression of improvement in their tinnitus after treatment.CCH was no better than counselling in reducing the impact of tinnitus using the three quantative measures of tinnitus, and requests for further follow up.The only significant difference between the two therapies was that 20 (45.5 per cent) of the CCH group reported a general sense of improvement compared to six (14.3 per cent) in the counselling group, this is significant p<O.Ol. The study did not demonstrate whether this was a genuine hypnotic effect or simply a response to the additional attention from the therapist.