US-based hearing health company Envoy Medical has received the US Food and Drug Administration (FDA) approval for its Investigational Device Exemption (IDE) application to begin a study of its Acclaim Fully Implanted Cochlear Implant (Acclaim CI).
Acclaim CI is a fully implanted hearing device designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids.
It differs from existing cochlear implants by comprising an implanted sensor that leverages the natural anatomy of the ear to capture sound, instead of using a microphone.
The US health agency approved the IDE application as a staged clinical study, which allows preliminary data collection on a subset of patients before expanding it into a full cohort.
The medical technology company is planning to select top cochlear implant institutions in the US as investigational sites for the study.
Envoy Medical CEO Brent Lucas said: “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.”
The Acclaim Cim, which received the US FDA Breakthrough Device Designation in 2019, is expected to be indicated for adults who are deemed eligible by a qualified physician.
Envoy said its other device, the Esteem fully implanted active middle ear implant (FI-AMEI), received FDA approval for use in adults with moderate to severe sensorineural hearing loss.
Designed to be invisible, FI-AME has no external components or needs ear canal insertions.
Last week, the American Medical Association approved new CPT codes for totally implantable active middle ear implants, which expands opportunities for the company’s Esteem device.
Lucas added: “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.
“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.”
