Digital Therapeutics in Tinnitus Care: A Feasibility Study of the Oto Smartphone Application

Background: Tinnitus is a prevalent condition affecting approximately 14.4 percent of the global adult population. With growing mobile phone ownership and usage globally, the utilization of smartphone applications (apps) as tinnitus interventions has garnered research and clinical interest. Despite the abundant number of commercially available tinnitus smartphone apps, a majority of them lack validation of their effectiveness.Purpose: The goal of this study was to investigate the feasibility of using a smartphone app (Oto) in tinnitus management as determined by trial acceptability, deliverability, and effectiveness.Research Design: A two-arm controlled trial design was adopted.Study Sample: Sixty-two adults with chronic tinnitus were randomized to either the Oto user group or nonuser (control) group.Intervention: The multimodal Oto smartphone app, which combines patient education, cognitive behavioral therapy, relaxation, mindfulness, and sound therapy, was used by the Oto user group for 3 months.Data Collection and Analysis: Participants completed the Tinnitus Functional Index (TFI) at baseline, 1 month, and 3 months. The Oto user group rated Oto's ease of use and their satisfaction on a 5-point Likert scale and answered open-ended questions on user experience at 3 months. One-way repeated-measures analysis of variance was performed with Bonferroni correction.Results: Overall retention rate (defined as completion of trial at 3 months) was 87 percent. Among Oto users, 16 percent had a clinically meaningful reduction (≥13 points) in the TFI score from baseline to 3 months, whereas 7 percent of nonusers met the same criterion. The Oto user group showed no significant difference in TFI scores between baseline, 1 month, and 3 months, whereas the nonuser group showed a significant increase in the overall TFI scores from baseline to 1 and 3 months (F[2, 56] = 7.78, p = 0.001). Oto users found Oto easy to use and appreciated app features such as diversely themed therapy sessions and sound library. Suggestions including adjusting the duration of therapy sessions and a more structured habituation program were also noted for improving Oto.Conclusions: Use of Oto in managing tinnitus was demonstrated to be deliverable and feasible with a high retention rate. A large-scale randomized controlled trial is currently underway to further evaluate Oto's effectiveness and app usability.