America’s Food and Drug Administration (FDA) has approved a clinical trial of Envoy Medical’s Acclaim fully implanted cochlear implant, the first cochlear implant with no external device.
The company said the technology was a first-of-its-kind hearing device as it included a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound. This makes it different from existing cochlear implants on the market.
The device is designed to address severe to profound sensorineural hearing loss not adequately addressed by hearing aids.
“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. You can’t lose it. You don’t clean it. The implant offers true 24/7 hearing,” Envoy Medical said.
It announced on 1 November 2024 that its Investigational Device Exemption (IDE) application for the study had been approved.
“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 Mr 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.”
Envoy Medical plans to select some of the top cochlear implant institutions in America as investigational sites for the study, with a feasibility study taking place at Mayo Clinic.
“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,” said Lucas said.
“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 which allows preliminary clinical data to be gathered on a subset of patients before expanding enrolment to the full cohort.
Lucas said that, as with any investigational device, approval of an IDE application did not ensure that results of the investigation would provide a reasonable assurance of the safety and effectiveness or assure a determination of approval for a premarket submission.
Lucas said the American Medical Association recently approved new Current Procedural Terminology (CPT) codes for totally implantable active middle ear implants, which opened new opportunities for its already FDA-approved Esteem device, the world’s first fully implanted active middle ear implant.
