WHITE BEAR LAKE, MINNESOTA — Envoy Medical®, Inc. (NASDAQ: “COCH”), a hearing health company specializing in fully implanted hearing systems, announced the U.S. Food and Drug Administration’s (FDA) approval of its Investigational Device Exemption (IDE) application for a pivotal study of the Acclaim® Fully Implanted Cochlear Implant.
The Acclaim® technology includes an implanted sensor that leverages the ear’s natural anatomy to capture sound, distinguishing it from other cochlear implants currently available.
“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. Currently, it is estimated 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.”
–Brent Lucas, CEO of Envoy Medical
Envoy Medical intends to select leading cochlear implant institutions across the U.S. as investigational sites for the study and will release information on participating sites for interested patients as Institutional Review Board (IRB) approvals are obtained.
“The excitement around the Acclaim® device is palpable, and we have been extremely humbled by the number of top-tier cochlear implant programs that want to participate in this study,” added Lucas. “While we are not able to select every site for this study, we believe that this excitement and significant interest across the country is a strong signal of our potential ability to penetrate the market should we be successful in gaining commercial approval.”
The FDA’s approval of the IDE application allows for a staged clinical study, enabling preliminary data collection on a subset of patients before expanding enrollment to the full cohort. As with any investigational device, approval of an IDE application does not guarantee that the study results will confirm the device’s safety and effectiveness or assure regulatory approval for market entry.
Lucas also remarked, “The last two weeks demonstrate our passionate commitment to innovation, competition, and change in the hearing industry. Last week marked the American Medical Association’s approval of new CPT codes for totally implantable active middle ear implants, which opens new opportunities for our already FDA-approved Esteem® device. 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. We are excited about what the future holds for Envoy Medical.”
*Interested readers can view a 2023 interview with company CEO, Brent Lucas discussing the company’s updates, including the Mayo Clinic clinical trial:
About the Fully Implanted Acclaim® Cochlear Implant
We believe the fully implanted Acclaim Cochlear Implant will be a first-of-its-kind cochlear implant. Envoy Medical’s fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound.
The Acclaim is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician.
The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019. We believe the Acclaim was the first hearing-focused device to receive Breakthrough Device Designation and may still be the only hearing focused medical technology to receive the designation.
CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by United States law to investigational use.
Important safety information for the Esteem can be found at: https://www.envoymedical.com/safety-information.
About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI)
The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss, allowing for 24/7 hearing capability using the ear’s natural anatomy. The Esteem FI-AMEI hearing implant is invisible, requires no externally worn components, and nothing is placed in the ear canal for it to function. Unlike hearing aids, it does not need to be put on or taken off, cannot be lost, and does not require cleaning. The Esteem FI-AMEI hearing implant offers true 24/7 hearing.
*Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.
Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information.
About Envoy Medical Corporation
Envoy Medical Corporation is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. The company is dedicated to improving the quality of life for people with hearing loss through the development of implantable hearing devices.
Source: Envoy Medical
