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 would represent the start of a long-anticipated 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. If you have been told you need a cochlear implant, it is important that you listen to your healthcare providers and get one sooner than later.
Sign-up for updates!Like our existing Esteem Osseointegrated Active Middle Ear Implant, the Acclaim® will use our proven and novel sensor technology. It will leverage the natural anatomy of the ear rather than a microphone to capture sound entering the ear. The sound vibrations will then be processed into customized electronic signals. Then, the stimulator will send unique electrical signals to stimulate the cochlea and hearing nerve to receive sounds.
No external sound processor will allow for 24/7 hearing and in environments not ideally suited for external components
No expensive external sound processors to replace when lost or damaged
No daily battery changes. Implanted rechargeable battery expected to last several days between charges
No external artificial microphone. The ear will 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. This recognition and designation is promising as we seek pre-FDA approval for this device.
CAUTION: Investigational Device - Limited by Federal Law to Investigational Use.
