Envoy Medical has secured FDA clearance for its Investigational Device Exemption (IDE) application to initiate a study of the Acclaim cochlear implant (CI). This pivotal trial aims to evaluate the device's safety and efficacy in adults suffering from severe to profound sensorineural hearing loss who do not benefit adequately from conventional hearing aids.
The Acclaim CI distinguishes itself through an implanted sensor that harnesses the ear's natural anatomy to capture sound. This innovative approach seeks to provide a more natural and nuanced auditory experience for patients. The FDA's green light allows Envoy Medical to commence clinical data collection from an initial group of patients across various cochlear implant centers in the United States, with plans to broaden enrollment subsequently.
"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," said Brent Lucas, CEO of Envoy Medical. The Acclaim CI was previously granted breakthrough device designation by the FDA in 2019, underscoring its potential to address a significant unmet need in hearing loss treatment.
Envoy Medical's portfolio includes the Esteem fully implanted active middle ear implant (FI-AMEI), already FDA-approved for adults with moderate to severe sensorineural hearing loss. The Esteem device is designed for complete invisibility, requiring no external components or ear canal insertions. The recent approval by the American Medical Association (AMA) of new Current Procedural Terminology (CPT) codes for totally implantable active middle ear implants is expected to further expand opportunities for the Esteem device.
The Acclaim study represents a crucial step toward providing an alternative or supplementary treatment option for individuals with significant hearing impairment. The data collected will be instrumental in determining the device's performance and potential for broader clinical application.
