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

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

  • By

  • Koichiro Wasano

  • Taiji Kawasaki

  • Fumiyuki Goto

  • Yoshihiko Hiraga

  • Shinji Nagai

  • Madoka Tominaga

  • Kaoru Ogawa

  • July 1, 2026

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Objective:

To evaluate the efficacy of a smartphone-based cognitive behavioral therapy (CBT) app for managing chronic tinnitus in Japanese-speaking individuals.

Approach:
  • Study Design: A double-blind, sham-control, parallel-group comparative randomized clinical trial (RCT) conducted at three medical institutes in Japan.
  • Participants: Patients aged 18 to 75 years with mild to severe chronic tinnitus were enrolled, meeting specific inclusion criteria.
  • Intervention: Participants were assigned to either an active app delivering therapeutic content or a sham-control app lacking therapeutic content.
  • Assessment: Participants were evaluated at baseline and at weeks 4, 8, 12, 16, and 24 using the Tinnitus Handicap Inventory (THI) score.
Key Findings:
  • The active app included components such as disease education, relaxation exercises, cognitive training, and behavioral activation, which were designed to facilitate long-term habituation and symptom management for tinnitus.
Interpretation:

Digital therapeutics may provide an effective means to expand access to evidence-based tinnitus care, particularly in regions with limited availability of traditional CBT.

Limitations:
  • The study's sample size was limited to 60 participants, which may affect the generalizability of the findings.
  • The trial was conducted in a specific geographic region (Japan), which may limit applicability to other populations.
Conclusion:

The study presents findings on the use of a digital therapeutic app for managing chronic tinnitus, highlighting the need for accessible treatment options.

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