Envoy Medical, a company focused on fully implanted hearing systems, has announced FDA approval of its Investigational Device Exemption (IDE) application for a pivotal study of the Acclaim Fully Implanted Cochlear Implant. This approval marks a significant step toward providing a new option for individuals with severe to profound hearing loss.
The Acclaim Cochlear Implant distinguishes itself from traditional cochlear implants through its innovative sensor design. Instead of relying on external microphones, the Acclaim device is designed to leverage the natural anatomy of the ear to capture sound. This approach aims to offer a more discrete and potentially more natural hearing experience for patients.
Study Design and Objectives
The pivotal study will be conducted at leading cochlear implant centers across the United States. Envoy Medical plans to collaborate with top-tier institutions to gather comprehensive clinical data on the Acclaim device. The study is designed as a staged clinical trial, allowing for preliminary data collection on a subset of patients before full enrollment. This approach enables careful monitoring and assessment of the device's performance and safety.
Brent Lucas, CEO of Envoy Medical, expressed enthusiasm about the FDA approval, stating, "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 the significant unmet need in the cochlear implant market, estimating that roughly 95% of patients with significant hearing loss who could benefit from a cochlear implant have not received one. "We believe the differences in our device’s design provide an opportunity to pursue this important therapy in a more discrete manner and offer candidates a welcomed new option that may get more patients to embrace the potential benefits of a cochlear implant," Lucas added.
Implications for the Hearing Loss Community
The Acclaim Cochlear Implant is intended for adults with severe to profound sensorineural hearing loss who do not benefit adequately from hearing aids. The device received Breakthrough Device Designation from the FDA in 2019, underscoring its potential to address a significant unmet medical need. The fully implanted nature of the Acclaim device offers a potential advantage in terms of convenience and aesthetics, as it eliminates the need for external components.
Envoy Medical's Broader Portfolio
In addition to the Acclaim Cochlear Implant, Envoy Medical markets 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 is designed for 24/7 hearing capability and utilizes the ear's natural anatomy. The recent approval of new CPT codes for totally implantable active middle ear implants further expands the opportunities for the Esteem device.
"The last two weeks demonstrate our passionate commitment to innovation, competition, and change in the hearing industry," said Lucas. "This week, we are celebrating IDE approval to start a pivotal study for our investigational Acclaim device. Two devices serving two patient populations, both moving the hearing industry forward. We are building a company that is positioning itself to be a market segment leader in the hearing industry."
