IU104 - Oto’s Digital Tinnitus Therapeutic vs. One to one tinnitus therapy: Results from the DEFINE Randomized Controlled Trial

Abstract:
The DEFINE trial compared Oto’s smartphone-based digital tinnitus programme to therapist-delivered CBT in a randomised controlled trial. Enrolling 210 participants, it measured tinnitus severity (TFI), quality of life (EQ-5D-5L, HUI3), and usability (SUS). Results show Oto’s digital programme is non-inferior to traditional CBT, achieving comparable reductions in tinnitus severity and improved quality of life. The DEFINE trial highlights the transformative potential of digital therapeutics, offering a scalable, cost-effective alternative to face-to-face therapy for tinnitus.

Summary:
Introduction
Tinnitus affects around 10% of the adult population worldwide, with a significant subset reporting a negative impact on their quality of life. Cognitive behavioural therapy (CBT) has been shown to reduce tinnitus-related distress and improve coping strategies, but access to therapist-led CBT is limited due to time, cost, and workforce constraints. The DEFINE trial (ISRCTN99577932) investigates whether
a smartphone-based tinnitus management programme, incorporating CBT, is as effective as traditional therapist-delivered tinnitus therapy and CBT in reducing tinnitus severity and improving quality of life.

Rationale
The DEFINE trial evaluates the efficacy of the Oto digital tinnitus programme, which combines CBT with mindfulness, relaxation techniques, and sound therapy, in a user-friendly smartphone application. By offering a scalable and accessible form of therapy, the study aims to address the gap in treatment availability while maintaining clinical efficacy. This randomised controlled trial explores the non-inferiority of the digital intervention compared to therapist-led CBT in reducing tinnitus severity.

Methods
This prospective, open-label, randomised controlled trial enrolled 210 participants with chronic tinnitus, recruited remotely, and randomised in a 1:1 ratio to either the Oto digital tinnitus programme (intervention arm) or therapist-delivered CBT (control arm). Outcome assessments were conducted at baseline, 1 month, 3 months, 6 months, and 12 months.

Primary Outcome
The primary outcome was the reduction in tinnitus severity, measured using the Tinnitus Functional Index (TFI) at 6 months post-randomisation. The well-validated TFI assesses tinnitus impact across eight domains, including intrusiveness, sense of control, cognitive interference, and sleep disturbance.

Secondary Outcomes
Secondary outcomes include:
1. Health-related quality of life, assessed via the EuroQol EQ-5D-5L and the Health Utilities Index Mark 3 (HUI3), at 3, 6, and 12 months.
2. 3. 4. Intervention usability, evaluated using the System Usability Scale (SUS) at 3 months. Adverse events and safety monitoring, documented throughout the trial.
Participant experience and satisfaction, gathered through qualitative analysis of focus group discussions and semi-structured interviews conducted at 3, 6, and 12 months.
5. Economic analysis, based on a cost-utility evaluation using Quality-Adjusted Life Years (QALYs) derived from the EQ-5D-5L and HUI3
scores.

Results
Primary endpoint analysis at 6-months indicates that the Oto digital programme is non-inferior to therapist-delivered CBT in reducing tinnitus severity, as measured by the TFI. Preliminary data analysis at 1,3 and 6 months shows significant improvement in tinnitus-related distress, with comparable outcomes between the two groups. Usability of the Oto app has been rated highly by participants.

The final cohort of participants will reach the 12-month endpoint by the end of 2024, with the complete results to be presented at the AAA conference – the first worldwide presentation of DEFINE trial data at a scientific meeting.

Conclusions
The DEFINE trial supports the potential of digital therapeutics for tinnitus management, demonstrating that app-based tinnitus therapy including CBT is a viable, cost-effective alternative to traditional therapist-delivered interventions. With comparable outcomes in tinnitus severity reduction and quality of life improvement, digital therapy offers a scalable solution for improving access to tinnitus care.

Brief Summary of Clinical Takeaways: The clinical takeaway for this session is that digital therapeutics may provide cost- and clinically-effective and tailored treatment for adults with tinnitus. These therapeutics should be considered for participants as part of a range of tinnitus treatment options, particularly where cost- efficiency and large scale implementation are considerations.
Course Content Disclosure: This course will discuss a specific product or service offered by the exhibiting company leading this presentation with limited to no information about like products or services.