Envoy Medical Corp.

Envoy Medical announced today that it received FDA investigational device exemption (IDE) for its Acclaim cochlear implant.

White Bear Lake, Minnesota-based Envoy Medical will begin a single-center IDE early feasibility study with the fully implanted Acclaim cochlear implant at Mayo Clinic in Rochester, Minnesota.

The company said in a news release that its Acclaim implant represents a new option unlike current commercially available cochlear implants due to the lack of any externally worn components. It received FDA breakthrough device designation in 2019.

If approved by the FDA, Acclaim would be the first of its kind as a cochlear implant designed to be fully implanted using the ear, rather than a microphone, to pick up sound, Envoy said. The design leverages the natural anatomy of the ear to capture sound in an effort to address the limitations of current microphone-based hearing devices.

Mayo Clinic practicing neurologist and professor of otol…

Envoy Medical’s Esteem AMEI. (Image from Envoy)

Envoy Medical announced today that its Esteem middle ear implant showed statistically significant improvements in postoperative results.

White Bear Lake, Minn.-based Envoy’s Esteem osseointegrated active middle ear implant (AMEI) is for patients with moderate-to-severe sensorineural hearing loss who have failed to benefit from traditional amplification like hearing aids. Esteem is the first and only fully implanted AMEI approved by the FDA.

The device was used in all patients enrolled in the independent study and, according to the results, published in The Journal of Laryngology & Otology, provided overall significant improvement in pure-tone average (PTA) and word recognition score at a hearing level of 50dB.

According to a news release, 116 implants were placed between November 2011 and August 2016, including those in many patients who reported subjective suboptimal performance with tradit…