Summary: Envoy Medical received FDA approval to begin a pivotal study of its Acclaim Fully Implanted Cochlear Implant, which uses the ear’s natural anatomy to capture sound, offering a new option for patients with severe to profound hearing loss.
Takeaways:
- The FDA has approved Envoy Medical’s Investigational Device Exemption (IDE) for a staged clinical study of the Acclaim device, allowing preliminary data collection before full enrollment.
- The Acclaim Cochlear Implant utilizes a unique sensor design that leverages the ear’s natural structure, differing from traditional cochlear implants that rely on external microphones.
- Envoy Medical’s IDE approval, along with new CPT codes for its Esteem device, positions the company as an innovator in fully implanted hearing solutions.
Envoy Medical, a hearing health company focused on fully implanted hearing systems, announced that its Investigational Device Exemption (IDE) application for its pivotal study of the Acclaim Fully Implanted Cochlear Implant has been approved by the U.S. Food and Drug Administration (FDA).
The Acclaim technology includes an implanted sensor designed to leverage the natural anatomy of the ear to capture sound, making it different from existing cochlear implants on the market.
“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,” says Brent Lucas CEO of Envoy Medical. “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.”
An FDA-Approved Study
The company plans to select some of the top cochlear implant institutions in the U.S. as investigational sites for the study. As IRB approvals are obtained, the company will share information on the investigational sites for interested patients.
“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,” says 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 approved the IDE application as a staged clinical study. This allows preliminary clinical data to be gathered on a subset of patients prior to expanding enrollment to the full subject cohort. As with any investigational device, approval of an IDE application does not ensure that the results of the investigation will provide a reasonable assurance of the safety and effectiveness or assure a determination of approval for a premarket submission.
“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,” says 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. We are excited about what the future holds for Envoy Medical.”
Further reading: Envoy Medical Secures Patent for Safe Recharge Tech in Fully Implanted Hearing Devices
About the Fully Implanted Acclaim Cochlear Implant
Envoy Medical’s fully implanted Acclaim Cochlear Implant (Acclaim CI) includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound.
The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI 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.
The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.
About the Esteem Fully Implanted Active Middle Ear Implant (FI-AMEI)
The Esteem fully implanted active middle ear implant (FI-AMEI) is an 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 and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. 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.
Photo: Dreamstime
