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

Clinical Question

In adults with chronic, bothersome tinnitus, does a smartphone-based cognitive behavior therapy (CBT) and counseling app reduce tinnitus-related distress more than a sham app over 16 weeks?

Bottom Line

In adults with mild to severe chronic tinnitus, the therapeutic app produced a substantially greater reduction in Tinnitus Handicap Inventory (THI) scores at 16 weeks than the sham app, exceeding the minimal clinically important difference. This benefit persisted eight weeks after discontinuing therapeutic content, and no serious adverse events or hazardous device malfunctions were observed.

Background: Chronic tinnitus, defined as the perception of sound in the absence of an external stimulus, affects roughly 14% of the global population, with a subset experiencing significant interference with daily life and quality of life.

CBT and hearing aid-based interventions can reduce tinnitus-related distress, and CBT is guideline-recommended first-line care, but access to trained therapists is limited, especially in Japanese otolaryngology practice. Digital therapeutics—regulated software medical devices—offer scalable, remote delivery of evidence-based care and have shown benefits in other conditions, prompting development of tinnitus-specific CBT apps.

Study Design: Double blind, sham-controlled, parallel-group randomized clinical trial at three Japanese otolaryngology centers from September 2023 to February 2025, with a 16-week treatment phase and an eight-week follow-up. Adults aged 18-75 years with mild to severe chronic tinnitus (THI ≥18, symptom duration between three months and four years, more than 28 days since initial tinnitus visit) and compatible smartphones were randomized 1:1 to an active therapeutic app or sham app using a minimization method balancing sex, age, and baseline THI.

Setting: Tokai University Hospital, Oto Clinic Tokyo, and Japanese Red Cross Shizuoka Hospital in Japan

Synopsis: Sixty participants (33 female; median age 58.5 years) with mostly mild–moderate hearing loss were allocated to the active app (n=30) or sham app (n=30), forming the full analysis set.

The active app delivered fully automated daily sessions combining educational counseling with CBT-based modules: disease education, relaxation exercises (e.g., breathing, muscle relaxation), cognitive training (reinterpretation, restructuring, attention shifting, mindfulness), and behavioral activation targeting avoidance behaviors. The sham app matched the interface and recording function but removed tinnitus-specific education and CBT elements, instead providing brief self-monitoring messages; both apps collected electronic patient-reported outcomes.

The primary outcome was THI change from baseline to week 16, and secondary outcomes included the Tinnitus Functional Index (TFI), tinnitus annoyance and control numeric rating scales, the Hospital Anxiety and Depression Scale, the Athens Insomnia Scale, and the Patient Global Impression of Improvement. By week 16, THI decreased by −16.8 points (95% CI, −22.7 to −11.0) in the active group versus +3.6 (95% CI, −2.3 to +9.4) in the sham group, with a between-group difference of −20.4 points. This advantage remained at week 24 with a −18.3-point difference. TFI, tinnitus annoyance and control scores, anxiety, and insomnia also improved significantly in the active group compared with sham, and 70% of active app users achieved at least a seven-point THI reduction versus 27% with sham. Adherence was high in both groups, and no serious adverse events or clinically important device malfunctions were reported.

Citation: Wasano K, et al. Mobile application as a digital therapeutic for chronic tinnitus: a randomized clinical trial. JAMA Otolaryngol Head Neck Surg. 2026;152:677-685. https://doi.org/10.1001/jamaoto.2026.0858.

Comment: Tinnitus is a challenging disorder that has no cure and can be severely debilitating. The authors present an excellent clinical trial looking at the effects of CBT and educational counseling on chronic tinnitus. They have developed a prototype digital mobile application on a smartphone to deliver the therapy, with the hope that this will allow for greater accessibility to treatment for tinnitus patients. They also use a novel methodology of comparing tinnitus outcomes in patients who used the therapeutic application with those who used a sham application (which had explanations emphasizing the importance of self-monitoring for symptom management but with the CBT elements removed). Their findings of a significant and long-lasting improvement in the THI with the therapeutic application are promising for this population of patients for whom effective treatment options are limited. —Robert Hong, MD, PhD