Envoy Medical can now begin an early feasibility study for the Acclaim cochlear implant because the FDA has approved the company's application for an investigational device exemption (IDE).

The company will carry out the single-center study of the brand-new, fully implanted cochlear implant pipeline products market at the Rochester, Minnesota, United States, Mayo Clinic.

Instead of using a microphone to pick up sound that enters the ear, the new Acclaim sensor technology was made to use the natural anatomy of the ear.
It was designed to overcome the drawbacks of the current microphone-based hearing aids.

The ear will process the sound vibrations into customized electronic signals. After that, the individual electrical signals that the stimulator sends will stimulate the cochlea and hearing nerve to receive sounds.

The new device uses an embedded rechargeable battery that can last several days between charges and is designed without an external artificial microphone.

The US Food and Drug Administration granted Acclaim Breakthrough Device Designation in 2019.

To know about the assumptions considered for the study, Download for Free Sample Report

In addition, Acclaim was accepted into the FDA's Early Feasibility Study Program for the Center for Devices and Radiological Health.
Envoy Medical stated that Acclaim would be the first-of-its-kind cochlear implant to use the ear rather than a microphone if it received regulatory approval.

Brent Lucas, CEO of Envoy Medical, stated: Millions of adults with significant hearing loss may use a fully implanted cochlear implant, in our opinion.

"This study is the first step in evaluating the fully implanted Acclaim cochlear implant's safety and effectiveness, moving us closer to potentially filling a large unmet need in hearing loss technology."