BionicVEST-2 · EUROPEAN DEVELOPMENT OF A FIRST COMMERCIAL BIONIC VESTIBULAR IMPLANT FOR VESTIBULAR DYSFUNCTION - 2

In this project we present a solution to restore balance and prevent falls through vestibular implantation and electrical stimulation of the otolith organ. Worldwide, about 684.000 individuals die from falls each year and 37.3 million falls require medical attention. The medical cost for treating falls in the EU is approximately 25 billion euros each year. This number can be expected to go up since the elderly population is growing. One of the most important causes of falling is vestibular dysfunction. Therefore, restoration of the vestibular function may revolutionize this field because it offers a whole new treatment paradigm. The foundation of vestibular dysfunction treatment was laid during the Bionic\VEST H2020 FET-OPEN project funded by the EU. This FET-OPEN project obtained spectacular results and showed that the successful restoration of vestibular function through electrical stimulation of the otolith organ is possible. Where there was no suitable treatment before, balance improvement and even restoration is feasible. The result of this first Bionic\VEST FET-OPEN project was a proof-of-principle on humans with a prototype otolith vestibular implant. To unlock the full commercial potential of this vestibular restorative therapy, the new Bionic\VEST-2 project will focus on the path to commercialization of the Bionic\VEST implant. This requires improvements in the implant technology to achieve its full potential on the market. A pivotal clinical trial will have to be run with the new device to provide evidence for the safety and efficacy of the final implant, as well as gather data for health economics. Further, novel diagnostic clinical tools will be developed to identify the patients that can benefit from this technology promptly. In-depth market research and an elaborated business case should confirm that the vestibular implant will bring the long-awaited solution for vestibular disorders and ameliorate the enormous societal impact of this problem.