Mobile Application as a Digital Therapeutic for Chronic Tinnitus: A Randomized Clinical Trial - Scorecard - 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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Clinical Scorecard: Digital Therapeutic Mobile App for Managing Chronic Tinnitus: Results from a Randomized Clinical Study

At a Glance

CategoryDetail
ConditionChronic Tinnitus
Key MechanismsCognitive Behavioral Therapy (CBT) delivered via a mobile app
Target PopulationJapanese-speaking individuals aged 18 to 75 with chronic tinnitus
Care SettingClinical trial conducted at multiple medical institutes in Japan

Key Highlights

  • 14.4% global prevalence of tinnitus; 2.3% significantly interferes with daily life
  • CBT is recommended as a first-line treatment for tinnitus
  • Digital therapeutics offer scalable access to evidence-based treatments
  • Study utilized a double-blind, sham-control, parallel-group RCT design
  • Active app includes disease education, relaxation exercises, cognitive training, and behavioral activation

Guideline-Based Recommendations

Diagnosis

  • Use Tinnitus Handicap Inventory (THI) for assessment

Management

  • Implement Cognitive Behavioral Therapy (CBT) as a primary treatment approach

Monitoring & Follow-up

  • Conduct follow-up assessments at specified intervals (weeks 4, 8, 12, 16, and 24)

Risks

  • Limited access to CBT in certain geographic areas may affect treatment availability

Patient & Prescribing Data

Individuals with mild to severe chronic tinnitus

Digital delivery of CBT may enhance access to treatment

Clinical Best Practices

  • Ensure informed consent and adherence to ethical guidelines in clinical trials
  • Utilize validated assessment tools like THI for patient evaluation
  • Consider digital therapeutics as a viable option for expanding access to care

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