Envoy Medical, Inc. (NASDAQ: COCH) has received FDA approval to initiate a pivotal clinical study for its Acclaim® Fully Implanted Cochlear Implant. This approval marks a significant advancement in the development of a novel hearing solution for individuals with severe to profound hearing loss.
Acclaim Cochlear Implant: A Novel Approach to Hearing Loss
The Acclaim CI distinguishes itself from traditional cochlear implants through its innovative design. Instead of relying on a microphone, the device incorporates an implanted sensor that leverages the natural anatomy of the ear to capture sound. This approach aims to provide a more discrete and natural hearing experience for patients.
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." He also noted that approximately 95% of patients with significant hearing loss who could benefit from a cochlear implant have not received one, suggesting a substantial unmet need that Acclaim aims to address.
Clinical Study Design and Implementation
The pivotal study will be conducted at leading cochlear implant centers across the United States. The FDA has approved a staged clinical study design, allowing for the collection of preliminary clinical data on a subset of patients before expanding enrollment to the full cohort. This approach enables careful monitoring and assessment of the device's performance and safety.
Lucas expressed enthusiasm about the high level of interest from top-tier cochlear implant programs to participate in the study, indicating strong confidence in the potential of the Acclaim device. However, he also acknowledged that not all interested sites could be selected for the study.
Addressing a Significant Unmet Need
The Acclaim CI is designed to address severe to profound sensorineural hearing loss in adults who are not adequately helped by hearing aids. The device received Breakthrough Device Designation from the FDA in 2019, highlighting its potential to provide a significant improvement over existing technologies.
Envoy Medical's Broader Portfolio
In addition to the Acclaim CI, Envoy Medical offers the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI), an FDA-approved device for adults with moderate to severe sensorineural hearing loss. The Esteem FI-AMEI provides 24/7 hearing capability without any externally worn components.
Lucas emphasized the company's commitment to innovation and competition in the hearing industry, noting the recent American Medical Association (AMA) approval of new CPT codes for totally implantable active middle ear implants, which benefits the Esteem device.
CAUTION: The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.
