Effectiveness of app-delivered tinnitus therapy

This study is a randomised controlled study aiming to evaluate the effectiveness of Oto, a smartphone app developed by Oto Health Ltd., which aims to help people manage their tinnitus and decrease their tinnitus severity. Oto is a novel multimodal app-delivered approach to tinnitus available for iOS and Android. It combines patient education, cognitive behavioural therapy (CBT), relaxation, mindfulness, and sound therapy in a customisable package. In particular, Oto provides a five-week tinnitus habituation program consisting of 60 recorded therapy sessions focusing on topics such as acceptance and commitment therapy (ACT), CBT, relaxation, mindfulness, and visualisation. Oto also offers a total of 116 therapy sessions (including those in the habituation program) that can be listened at the participants' own pace if they wish to explore beyond the habituation program. In general, each therapy session takes approximately 5-10 minutes to complete. Furthermore, Oto provides a sound library consisting of 78 kinds of sounds such as ocean, brown noise, and thunderstorm for masking tinnitus and facilitating sleep. Usage of Oto is self-paced and at the comfort of the participants' own home, though a suggested timescale for the habituation program is provided within the app. The self-paced and self-administered delivery method allows patients to avoid taking time off work, travel time to a hospital, and face-to-face contact with other people if necessary. As the nature of Oto is self-guided, all components of the app are optional based on the participants' needs and interests. However, Oto users were advised at the baseline to follow the suggested timeline for the habituation program as much as they could. No strategy was used to monitor adherence to using Oto, but participants' online written consent was sought to collect app usage data from Oto's end and these data will be de-identified and used for data analysis. Oto has received Medicines and Healthcare products Regulatory Agency (MRHA) certification as a Class 1 medical device in the UK. Participants in the Oto-user group were given cost free access to Oto for nine months (length of study period). An online focus group consisting of 10-12 Oto users will be organised at 6-months to discuss 1) barriers to seeking and obtaining advice and treatment for tinnitus, 2) participants' ideas, concerns, and expectations about Oto, 3) their interaction with Oto, 4) suggested improvements to the delivery or content of Oto, and 5) how Oto would best be employed within the Hearing Services Program (HSP) or hearing care system. Microsoft Teams will be used to record and transcribe the discussion after participants have provided online written consent. The focus group will be conducted by Boaz Mui, the principal investigator of this trial. Participants will be selected by purposeful sampling based on demographic characteristics (e.g., age, gender, tinnitus duration) to ensure recruitment of participants with different characteristics.