A recent clinical publication in the Journal of Clinical Medicine (JCM) highlighted early surgical experience with Envoy Medical, Inc.?s (?Envoy Medical?) investigational Acclaim® fully implantable cochlear implant. According to the publication, "All three surgeries proceeded without complication, and at activation, all three patients were hearing through their devices. Surgery is more technically challenging compared to a standard cochlear implant, but the skills needed can be mastered by a dedicated otologic surgeon." The Company currently expects to file for an investigational device exemption (IDE) in early 2024 to commence a pivotal clinical trial later that year.

Current cochlear implants rely on bulky external hardware that are held in place on the head by a magnet, which can cause discomfort and may not be suitable for all activities, including sleeping, showering, swimming, strenuous activity and other common daily events.  Envoy Medical?s device, the fully implanted Acclaim® cochlear implant seeks to alleviate these limitations by being the first fully implanted cochlear implant (sometimes referred to as a totally implanted cochlear implant or ?TICI?). By using an implanted middle ear sensor and an implanted rechargeable power supply, Acclaim® aims to eliminate the need for any externally worn components. Acclaim was granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) and is currently in an early feasibility study at Mayo Clinic (Rochester, Minnesota).

Envoy Medical?s Acclaim® may become the first fully implanted cochlear implant to begin a pivotal trial in the United States. Unlike other cochlear implants, Acclaim® intends to leverage the patient?s natural ear ? rather than an external microphone ?

to capture acoustic energy. The Acclaim® is designed to not require the use of an external processor during the day or daily recharging. The Mayo Clinic authors note: ?While it is only conjecture at this point, one may presume that increased breadth and comfort of use may improve quality-of-life for many recipients, particularly those who feel their disability prevents them from taking part in certain activities.?

The authors also highlight that this novel device is still developing. Certain patients may not be good candidates and that programming requires careful monitoring. If approved by the FDA, Envoy Medical intends to target a significantly under-penetrated adult cochlear implant market, which it believes to be more than $80 billion in the US.

The paper notes that the success of cochlear implants has resulted in steadily widening the criteria by which patients can qualify for a cochlear device.