New access to gold-standard tinnitus care as only 2.1% of patients currently receive CBT
London, UK – 28th October 2024 – Oto, the pioneering digital therapeutic for tinnitus management, has achieved CE marking as a Class I medical device in Europe. This significant regulatory milestone allows Oto to be marketed across Europe as the first English language cognitive behavioural therapy (CBT)-based digital treatment specifically for tinnitus, addressing a critical need for patients.
Currently, only 2.1% of people with tinnitus have access to CBT, the gold-standard treatment, due to a shortage of qualified practitioners and high costs associated with in-person care (1)(2). With CE marking, Oto now brings immediate and affordable access to CBT for millions who suffer from the debilitating condition.
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“Achieving CE marking is a transformative step for tinnitus care across Europe,” says Edmund Farrar, CEO of Oto. “With this approval, Oto can deliver evidence-based treatment to any tinnitus sufferer with a mobile device, wherever they are. This is a gamechanger for the clinicians that have limited options to manage their patients’ tinnitus” He adds, “Our ongoing DEFINE trial, conducted with the University of Cambridge, further solidifies Oto’s role in tinnitus management by comparing its outcomes directly with face-to-face CBT. We’re excited to share the results when the trial completes in early 2025.”
Oto’s CE-marked status allows healthcare professionals, including audiologists and ENT specialists, to confidently recommend Oto as a safe, accessible digital therapeutic. The app combines expert-guided CBT modules with mindfulness and sound therapy, all designed to change the brain’s response to tinnitus and improve users’ quality of life. With over 100,000 users and a strong clinical foundation, Oto is poised to set a new standard in tinnitus care in Europe.
References
- https://www.apple.com/newsroom/2024/05/apple-hearing-study-shares-preliminary-insights-on-tinnitus/
- https://pubmed.ncbi.nlm.nih.gov/30847513/
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