Towards digital solutions for tinnitus: a randomized controlled trial of the Oto smartphone application

To evaluate the effectiveness and usability of the Oto smartphone app in reducing tinnitus severity and distress. A prospective, unblinded randomized controlled trial (ANZCTR registration number: ACTRN12623001138673) with two arms: (i) intervention, and (ii) wait list control. Intervention arm received subscription to Oto. Ninety-six Australian adults experiencing chronic tinnitus (≥6 months). The overall TFI score in the intervention group showed statistically significant improvement compared to the control group from baseline to 6 months (mean decrease = 9 points, p = .006, 95% CI [2, 16]). A significantly higher proportion of intervention group (32%) reported clinically meaningful reduction in overall TFI score (≥13 points) than control group (12%) at 6 months, z = 2.20, p = .030. Significant interaction effects (time x treatment group) in overall TFI score were observed at 6 months, p < .001, Cohen’s d = 0.62, and 9 months, p = .002, Cohen’s d = 0.54. App usability was rated high on the mHealth App Usability Questionnaire (MAUQ) at 5.1 out of 7. Overall dropout rate was 21%. Use of Oto was effective in reducing tinnitus severity and distress. Future evaluation should consider including a wider range of tinnitus-related outcome measures and collection of qualitative data on user experience.Trial registration: Australian New Zealand Clinical Trials Registry identifier: ACTRN12623001138673..