Abstract
BACKGROUND: Tinnitus is a major health issue, but currently no tinnitus elimination treatments exist for chronic subjective tinnitus. Acoustic therapy, especially personalized acoustic therapy, plays an increasingly important role in tinnitus treatment. With the application of smartphones, personalized acoustic stimulation combined with smartphone apps will be more conducive to the individualized treatment and management of patients with tinnitus. OBJECTIVE: The aim of this study was to evaluate the efficacy of a new personalized approach known as the digital frequency customized relieving sound (DFCRS) for tinnitus treatment and to explore the factors that may influence its therapeutic effect. METHODS: Patients with subjective tinnitus were enrolled in this study from July 14, 2020, to May 24, 2021, in the tinnitus specialist clinic of Eye and ENT Hospital, Fudan University, Shanghai, China. In this nonrandomized concurrent controlled trial, a total of 107 participants were assigned to listen to personalized DFCRS through our developed app, while the other 77 participants who did not want to download and use the app were assigned to listen to unmodified music (UM). All the recruits were instructed to listen to DFCRS or UM for at least 2 hours a day and complete follow-up assessments at baseline, 1, 2, and 3 months. Multidimensional assessment scales, that is, Tinnitus Handicapped Inventory (THI), Hospital Anxiety and Depression 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. Linear mixed models were used to test for changes in the THI scores across 3 months of acoustic treatment between group (DFCRS or UM treatment) and time. A multiclass logistic model was built with a stepwise function to determine the influence of the different covariates on the effects of acoustic treatment. RESULTS: The results of the multidimensional assessment scales after 3 months of treatment showed that DFCRS-treated patients had significant tinnitus relief compared to those in the UM group. Linear mixed models revealed a significant reduction in the THI scores over time (P<.001), with the DFCRS group showing significantly greater improvement than the UM group (P<.001). At 3 months, 92.5% (99/107) of the patients undergoing DFCRS reported tinnitus relief or disappearance, and longer daily treatment time was associated with better outcomes (P=.007). Multiclass logistic regression confirmed that longer treatment time (odds ratio [OR] 13.07-64.78; P<.001) and more severe tinnitus at baseline (OR 10.46-83.71; P<.001) predicted better treatment response. All secondary outcomes (HADS, AIS, FTQ, TCS) showed significant improvements over time (P<.001). CONCLUSIONS: Our study suggests that DFCRS is a new promising and noninvasive therapy for chronic tinnitus, and it can be delivered through a mobile app to bring more convenience to patients with tinnitus.