CAUTION: Investigational Device - Limited by Federal Law to Investigational Use.
Drawing on our innovative past, Envoy Medical is developing and seeking regulatory approval for a new fully implanted cochlear implant, the Acclaim® Cochlear Implant. If approved by the Food and Drug Administration (FDA), it may lead to a shift from partially implanted cochlear implants to fully implanted cochlear implants.
This is an investigational device and it will be in clinical trials for several years. In addition, there is no guarantee that it will ever receive regulatory approval.
Sign-up for updates!The Acclaim® novel sensor technology is designed to leverage the natural anatomy of the ear rather than a microphone to capture sound entering the ear. The sound vibrations are intended to be processed into customized electronic signals. Then, the stimulator is intended to send unique electrical signals to stimulate the cochlea and hearing nerve to receive sounds.
Designed to function in environments not ideally suited for external components
Designed to use implanted rechargeable battery intended to last several days between charges
Designed without an external artificial microphone. The device is intended to allow the ear to pick up the sound naturally.
FDA Breakthrough Device Designation Status
In March 2019, Acclaim received the highly coveted Breakthrough Device Designation status. In addition, the Acclaim was previously accepted into the FDA’s Center for Devices and Radiological Health Early Feasibility Study Program.
CAUTION: Investigational Device - Limited by Federal Law to Investigational Use.
