Envoy Medical, Inc. (NASDAQ: COCH) has announced the enrollment of the first two participants in its pivotal clinical study evaluating the Acclaim® cochlear implant. This fully implanted device aims to provide a novel solution for individuals with severe to profound sensorineural hearing loss. The initial implantations were performed at the Ear and Hearing | Center for Neurosciences in Tucson, Arizona.
The Acclaim cochlear implant differentiates itself from traditional devices through its fully implanted design, eliminating the need for external components. Instead of relying on an external microphone, it utilizes a sensor that leverages the natural anatomy of the ear to capture sound. This design aims to provide "always-on" hearing with a battery life lasting multiple days between recharges.
Clinical Significance
According to Dr. Abraham Jacob, who performed the implantations, "Hearing loss is the most common human sensory disability and a modifiable risk factor for dementia." He added that the Acclaim system sets "a new benchmark within the hearing healthcare space" due to its potential for continuous hearing without external processors.
The pivotal clinical study will assess the safety and efficacy of the Acclaim CI to support a premarket approval (PMA) application to the FDA. The study builds upon an early feasibility study conducted at Mayo Clinic in 2022, where the device was first implanted in three participants. Modifications have been implemented based on the learnings from the early study.
Study Design and Participating Sites
In addition to the Tucson, Arizona site, six other investigational sites have been selected to participate in the pivotal study. These include Mayo Clinic, Medical University of South Carolina, University of Florida Health, Shohet Ear Associates, Hearts for Hearing, and Cleveland Clinic Foundation. Each site has dedicated surgeons and audiologists trained on the Acclaim device.
Device Details and Intended Use
The Acclaim CI is designed for adults with severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. It received Breakthrough Device Designation from the FDA in 2019, a testament to its potential to offer a significant improvement over existing technologies.
Brent Lucas, CEO of Envoy Medical, stated, "We strongly believe our fundamental design architecture is the right way to approach fully implanted cochlear implants and may provide our device with several competitive advantages." He also emphasized the company's commitment to continuous improvement of the device.
