Envoy Medical has received FDA approval for its Investigational Device Exemption (IDE) application to begin a study of the Acclaim cochlear implant (CI). This pivotal study aims to evaluate the safety and efficacy of the Acclaim CI in adults suffering from severe to profound sensorineural hearing loss who do not benefit sufficiently from traditional hearing aids.
The Acclaim CI distinguishes itself through its innovative design, featuring an implanted sensor that utilizes the natural anatomy of the ear to capture sound. This approach seeks to provide a more natural and nuanced auditory experience compared to conventional cochlear implants.
Brent Lucas, CEO of Envoy Medical, stated, "Receiving FDA approval to initiate this pivotal study marks a significant milestone in our efforts to bring this breakthrough hearing device to more people with severe to profound hearing loss." The company plans to collaborate with several cochlear implant centers across the US to conduct the investigational study.
This approval follows the American Medical Association's recent approval of new CPT codes for totally implantable active middle ear implants, expanding opportunities for Envoy Medical's FDA-approved Esteem device. The Acclaim CI received breakthrough device designation from the FDA in 2019, underscoring its potential to address a significant unmet need in the treatment of severe hearing loss.
Envoy Medical's Esteem fully implanted active middle ear implant (FI-AMEI) is already FDA-approved for adults with moderate to severe sensorineural hearing loss. The FI-AMEI is designed to be completely invisible, with no external components or ear canal insertions.
