Mobile Application as a Digital Therapeutic for Chronic Tinnitus: A Randomized Clinical Trial

Abstract

Importance: Tinnitus is a highly prevalent condition that has no cure and can severely impair quality of life. Patients who receive cognitive behavioral therapy (CBT) and hearing aid therapy for chronic tinnitus accompanied by hearing loss have shown some improvement, but access to these interventions is limited. Objective: To develop a prototype digital therapeutic mobile app that provides educational counseling and CBT elements for treating chronic tinnitus symptoms and test its efficacy and safety for 16 weeks in patients reporting distressing chronic tinnitus. Design, Setting, and Participants: This double-blind, sham-controlled randomized clinical trial was conducted from September 2023 to February 2025 in individuals diagnosed with mild to severe chronic tinnitus. The trial included a 16-week treatment phase followed by an 8-week follow-up phase. Data were analyzed from February to March 2025. Intervention: Participants used either the therapeutic app or a sham control app that lacked the therapeutic functions. During the 8-week follow-up, the app's therapeutic functions were blocked and only the app's recording function was available. Main Outcomes and Measures: The primary outcome was change from baseline to week 16 in the Tinnitus Handicap Inventory (THI) score, an index of tinnitus-related distress and functional impairment. Secondary outcomes were patient-reported and included THI, Tinnitus Functional Index, tinnitus loudness and control numeric rating scales, Hospital Anxiety and Depression Scale, Athens Insomnia Scale, and Patient Global Impression of Improvement. Results: A total of 60 participants (33 [55%] female; median [IQR] age, 58.5 [52.0-64.0] years) were assessed, including 30 participants in the therapeutic app group and 30 participants in the sham-control app group. The overall mean (SD) baseline THI was 41.3 (16.9). At week 16, the therapeutic app group showed significantly greater improvement in THI scores compared with the sham-control app group (between-group difference in change in THI, -20.4; 95% CI, -28.2 to -12.6). The therapeutic effect was maintained up to week 24 (mean between-group difference, -18.3; 95% CI, -26.4 to -10.1). Tinnitus worsened in 1 patient in the sham-control app group. No serious adverse events or device malfunctions with potential for health hazards were observed. Conclusions and Relevance: This randomized clinical trial found that use of a tinnitus therapeutic app resulted in substantial and lasting improvement in tinnitus-related distress and functional impairment. The therapeutic app may serve as an effective and standardized intervention for individuals with chronic tinnitus. Trial Registration: jrct.mhlw.go.jp Identifier: 032230359