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
Clinical Scorecard: Digital Therapeutic Mobile App for Managing Chronic Tinnitus: Results from a Randomized Clinical Study
At a Glance
| Category | Detail |
| Condition | Chronic Tinnitus |
| Key Mechanisms | Cognitive Behavioral Therapy (CBT) delivered via a mobile app |
| Target Population | Japanese-speaking individuals aged 18 to 75 with chronic tinnitus |
| Care Setting | Clinical 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
Related Resources & Content