JMIR Publications

ABSTRACT

Background:

Tinnitus is a major health issue, yet there are currently no tinnitus elimination treatments for chronic subjective tinnitus. Acoustic therapy plays an increasingly important role in tinnitus treatment, especially personalized acoustic therapy. With the application of smart phones, personalized acoustic stimulation combined with smart phone applications will be more conducive to the individualized treatment and management of tinnitus patients.

Objective:

To evaluate the efficacy of a new personalized approach known as the modified tinnitus relieving sound (MTRS) for tinnitus treatment and explore the factors that may influence its therapeutic effect.

Methods:

Patients with subjective tinnitus were enrolled in this study from 14 July 2020 to 24 May 2021, in the Tinnitus Specialist Clinic of Eye & ENT Hospital, Fudan University, Shanghai, China. The MTRS was generated according to the matched tinnitus pitch developed through our application, named the Fudan Tinnitus Relieving System (FTRS). A total of 107 participants were instructed to listen to the personalized MTRS for at least 2 h a day and other 77 participants to listen to the unmodified one. The patients who completed three consecutive months of assessment were included in the final analysis. Multi-dimensional assessment scales including tinnitus handicapped inventory (THI), hospital anxiety and distress scale (HADS), Athens insomnia scale (AIS), fear of tinnitus questionnaire (FTQ), and tinnitus catastrophizing scale (TCS) were used to evaluate the severity of tinnitus and the quality of life of patients with tinnitus from multiple dimensions. Statistical analysis of the results of the three follow-up visits with the baseline data allowed for an assessment of the efficacy of MTRS compared to the unmodified music (UM).

Results:

After 3 month- MTRS treatment, the MTRS-treated patients showed significant tinnitus relief compared to those from the UM group. The longer the time the patients received customized acoustic therapy, the more noticeable the improvement in patients' subjective reports on the impact of tinnitus. As the experiment proceeded, post-intervention scores on each subscale, including THI, HADS, AIS, FTQ, and TCS, significantly and consistently declined compared to the baseline data. Patients with severe tinnitus before the clinical trial tended to have better acoustic treatment results.

Conclusions:

Based on the results of the multi-dimensional assessment scale, the MTRS delivered by our self-designed mobile app, FTRS, showed significant efficacy after 3 consecutive months of treatment. In addition, the customized acoustic treatment effectiveness was positively correlated with total treatment time. Clinical Trial: ClinicalTrials.gov NCT04026932. Registered on 18 July 2019