THE VERTIGO! TRIAL: CURRENT STANDINGS AND NEXT STEPS IN EVALUATING THE EFFICACY AND SAFETY OF PROLONGED DAILY STIMULATION IN A MULTI-CANAL VESTIBULO-COCHLEAR IMPLANT (VCI) PROTOTYPE

When vestibular function is significantly reduced or lost in both ears, this is classified as bilateral vestibulopathy (BVP) – a disorder that profoundly reduces quality of life. Patients typically experience numerous symptoms, and management is often insufficient or limited to vestibular rehabilitation. Currently, there is no effective treatment available. As such, the Geneva-Maastricht group is investigating a combined multi-canal vestibulo-cochlear implant (VCI). This VCI aims to partially restore vestibular function in patients suffering from BVP. This ongoing trial is evaluating the safety and efficacy of prolonged VCI stimulation.
Ten cases with BVP and ipsilateral severe sensorineural hearing loss were implanted with the newest VCI prototype. The effect of VCI stimulation was assessed using several outcomes, including those related to VOR response, self-motion perception, posture, balance, and quality of life. For an extensive protocol: doi.org/10.1371/journal.pone.0301032.
Ten patients were successfully implanted with the VCI. Eye movements were elicited through electrical vestibular stimulation (9/10). Furthermore, VCI fitting and initial activation elicited eye movements and perceptions that were well-aligned. Dynamic ranges of vestibular implant electrodes were stable over time. Auditory performance using the VCI is comparable to regular CI use.
VCI implantation and activation is considered safe, with no serious adverse events recorded. Furthermore, VCI modulation demonstrated promising outcomes in numerous measures. These results confirm the artificial vestibular system's safety and efficacy in a hospital setting, supporting its readiness for daily use. The next step is to initiate the home-use part of the trial, which commenced January 2026.