Envoy Medical has received Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin a clinical trial with its fully implanted Acclaim cochlear implant.
The company will conduct the single-centre Early Feasibility Study for the Acclaim at Mayo Clinic in Rochester, Minnesota.
Due to the lack of any components that can be worn externally, the Acclaim differs from current commercially available cochlear implants and has received Breakthrough Device Designation by the FDA in 2019.
The Acclaim will also become the first cochlear implant of its sort created to be fully implanted and use the ear, rather than a microphone, to pick up the sound if it is cleared by the FDA.
Envoy Medical CEO Brent Lucas said: “We believe that a fully implanted cochlear implant may increase their use among millions of adults with significant hearing loss.
“This study is the first step in evaluating the safety and effectiveness of the fully implanted Acclaim cochlear implant, putting us closer towards potentially filling a large unmet need in hearing loss technology.”
Envoy Medical said that its fully implanted technology incorporates a totally novel sensor designed to use the natural anatomy of the ear instead of a microphone to capture sound, unlike the current microphone-based hearing devices.
The implant is a first-of-its-kind cochlear implant designed to address the hearing of adults suffering from severe to profound sensorineural hearing loss.
