Envoy Medical has received approval for its investigational device exemption (IDE) application from the US Food and Drug Administration (FDA), allowing the company to carry out an early feasibility study of the Acclaim cochlear implant.
The company will conduct the single-centre study of the new fully implanted cochlear implant at the Mayo Clinic, located in Rochester, Minnesota, US.
The new Acclaim sensor technology has been designed to use the natural anatomy of the ear rather than a microphone to pick up sound entering the ear.
It is developed to address the limitations of existing microphone-based hearing devices.
The sound vibrations entering the ear will be processed into customised electronic signals. The stimulator will then send the unique electrical signals to stimulate the cochlea and hearing nerve to receive sounds.
The new device is designed without an external artificial microphone and uses an implanted rechargeable battery, which can last several days between charges.
In 2019, Acclaim received Breakthrough Device Designation from the US FDA.
Furthermore, the FDA accepted Acclaim into its Center for Devices and Radiological Health Early Feasibility Study Program.
If approved by the regulator, Acclaim will become the first-of-its-kind cochlear implant to be completely implanted and use the ear, rather than a microphone, said Envoy Medical.
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.”