LONDON, UNITED KINGDOM – Oto, a pioneering digital therapeutic for tinnitus, has achieved CE marking as a Class I medical device in Europe. This regulatory milestone makes Oto the first English-language, cognitive behavioral therapy (CBT)-based digital treatment for tinnitus available across Europe, addressing a critical need for patients.
Currently, only 2.1% of tinnitus patients receive CBT, widely regarded as the gold-standard treatment, due to limited access to qualified practitioners and the high costs of in-person care. With CE marking, Oto offers immediate and affordable access to evidence-based CBT for millions affected by tinnitus.
“Achieving CE marking is a transformative step for tinnitus care across Europe,” said 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.”
“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.”
–Dr. Edmund Farrar, CEO of Oto
With CE-marked status, healthcare professionals, including audiologists and ENT specialists, can confidently recommend Oto as a safe, accessible digital therapeutic.
The app integrates CBT with mindfulness and sound therapy, all aimed at altering the brain’s response to tinnitus to improve users’ quality of life. With over 100,000 users and a solid clinical foundation, Oto is set to establish a new standard in tinnitus care across Europe.
Join us November 19-21 to gain valuable insights, learn practical tools, and engage with top experts in the field. With a diverse range of sessions designed for both professionals and the public, you’ll leave equipped to make an impact in tinnitus care.
References
- https://www.apple.com/newsroom/2024/05/apple-hearing-study-shares-preliminary-insights-on-tinnitus/
- https://pubmed.ncbi.nlm.nih.gov/30847513/
About Oto:
Oto provides accessible, evidence-based digital therapy for tinnitus, combining cognitive behavioral therapy (CBT), mindfulness, and sound therapy. Designed to help users manage their symptoms from any location, Oto’s app is built on clinical research and trusted by over 100,000 users worldwide. Through its CE-marked platform, Oto aims to set a new standard for tinnitus care.
Source: Oto
