NeuroEars Gets MFDS Approval for Confirmatory Clinical Trial of Vertigo Rehabilitation Digital Therapeutic

NeuroEars announced on the 13th that its virtual reality (VR) and artificial intelligence (AI)-based digital therapeutic for vertigo rehabilitation, 'NeuroEars-Thera™,' has received final approval from the Ministry of Food and Drug Safety (MFDS) for a confirmatory clinical trial. With this approval, the company will officially begin a multi-center confirmatory clinical trial.

'Vestibular rehabilitation exercises' are a proven treatment for improving vertigo symptoms. However, they have limitations such as low patient compliance due to monotonous repetitive movements and difficulty in confirming the accuracy of the exercises. The newly approved NeuroEars-Thera™ is a digital therapeutic that overcomes these limitations of existing vestibular rehabilitation treatments.

NeuroEars developed 'NeuroEars-Thera™' by fusing VR and AI technologies. This digital therapeutic is characterized by not only implementing rehabilitation exercises in a simple VR environment but also by tracking the patient's head and eye movements in real-time. It also provides feedback to enhance treatment effectiveness.

The product includes a wide range of vestibular rehabilitation programs and proprietary questionnaires, and provides clinical insights through AI-based analysis. Based on this, it can flexibly configure customized programs tailored to the individual patient's condition. In particular, it was developed to help patients become more immersed in and actively participate in the treatment process.

This confirmatory clinical trial will be a multi-center study involving several major general hospitals in South Korea, and is planned to be conducted for up to 12 months with a final target of about 100 patients. The subjects for the clinical trial are vertigo patients who experience discomfort in their daily lives.

In addition, the safety and effectiveness of the 'NeuroEars-Thera™' VR treatment method will be compared and evaluated against 'conventional vestibular rehabilitation exercises.' This is to objectively prove the effect of the digital therapeutic.

A NeuroEars representative said, "This confirmatory trial will prove that 'NeuroEars-Thera™' can provide a new treatment experience and effect for vertigo patients." He added, "Once the clinical trial is successfully completed, it will become a new treatment option for vertigo patients and is expected to become the first digital therapeutic in the vertigo field in Korea."

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