Envoy Medical®, a company dedicated to innovative hearing solutions, has successfully enrolled the first two participants in its pivotal clinical study for the Acclaim® cochlear implant, a fully implanted cochlear implant (CI). This study aims to evaluate the safety and effectiveness of the fully implanted device and support its future premarket approval (PMA) application. If proven successful, the Acclaim® cochlear implant could transform the cochlear implant industry by eliminating external components and leveraging the ear’s natural anatomy to process sound.

The first two participants were implanted at the Ear and Hearing Center for Neurosciences in Tucson, Arizona, by Dr. Abraham Jacob. The study includes six additional sites to further evaluate the safety and effectiveness of the device.

The Acclaim® cochlear implant received Breakthrough Device Designation from the FDA in 2019 and underwent initial testing in a 2022 feasibility study at Mayo Clinic in Rochester, Minnesota. Unlike traditional cochlear implants that rely on external microphones, the Acclaim® CI utilizes a piezoelectric sensor to capture sound naturally as it enters the ear. This approach reduces artificial sound distortion and enhances auditory perception. The processed sound signals are transmitted to an implanted electrode array, stimulating the cochlea and auditory nerve to send sound to the brain.

Designed for individuals with severe to profound sensorineural hearing loss who do not benefit from hearing aids, the Acclaim® CI offers a fully implanted solution without the external components of conventional cochlear implants. By integrating seamlessly with the body’s natural hearing mechanisms, it represents a significant step forward in hearing restoration technology.

The RestorEar team is excited to continue following the development and trial progression of this groundbreaking product, particularly as we continue recruitment for our own CI surgical device. Read more about Acclaim® here, and stay up to date on RestorEar’s clinical trials by subscribing to our newsletter or checking out our Clinical Page.