Envoy Medical, a Nasdaq-listed company focused on implanted hearing systems, has obtained European Patent No. 3858425, titled “Implantable Modular Cochlear Implant System with Communication System and Network.”
The European Patent Office’s approval grants Envoy Medical additional intellectual property rights over its cochlear implant technology.
The patent is related to a modular cochlear implant system capable of receiving input from both an implanted source and a wireless receiver. This system generates a stimulation signal that can be tailored through a programmable mixing ratio, allowing for adjustment between the contributions of different input sources.
Envoy Medical describes its Acclaim Cochlear Implant (Acclaim CI) as the first fully implanted hearing device of its type. The Acclaim CI includes a sensor that relies on the ear’s natural structure to capture sound, rather than using an external microphone.
The implanted hearing device is designed to assist adults with severe to profound sensorineural hearing loss that is not adequately treated by hearing aids. According to the company, candidates for the Acclaim CI will be evaluated by a qualified physician to confirm suitability for the implant.
In 2019, the US Food and Drug Administration (FDA) awarded the Acclaim CI a breakthrough device designation, indicating its potential to address treatment needs in hearing loss.
Envoy Medical also offers the Esteem fully implanted active middle ear implant (FI-AMEI), which is the only FDA-approved, fully implanted hearing device for adults with moderate to severe sensorineural hearing loss.
The Esteem FI-AMEI enables constant hearing capability, relying on the ear’s anatomy rather than external components, and does not require maintenance or parts that need to be worn or cleaned.
Earlier this month, Envoy Medical announced that the FDA had approved its investigational device exemption (IDE) application for a pivotal study of the Acclaim Fully Implanted Cochlear Implant. This study will evaluate the technology further, with investigational sites selected from leading U.S. cochlear implant institutions.
