Envoy Medical announced that the first three patients have been enrolled in the final stage of its pivotal clinical trial of the full implanted Acclaim cochlear implant.
The Acclaim cochlear implant is an investigational device engineered to operate without external wearable components. Unlike conventional cochlear implants, it uses a novel sensor to capture sound leveraging the ear's natural anatomy, removing the need for an external microphone or sound processor. This fully implanted design also supports patient choice to use standard in-ear devices such as earbuds or headphones, facilitating additional flexibility and differentiation from traditional cochlear implants.
A total of 46 patients will be implanted in the final stage of the trial; with today's news, 43 spots remain. Seven clinical trial sites are participating, and several additional surgeries are already scheduled with many more potential participants actively progressing through the screening process. Enrollment is proceeding efficiently. The strong interest underscores the momentum behind Envoy Medical's mission and the untapped demand for a fully implanted cochlear implant.
