Meet the fully implanted Acclaim® cochlear implant, an investigational device

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CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by United States law to investigational use.

Envoy Medical’s fully implanted Acclaim® cochlear implant, an investigational device, is a first-of-its kind cochlear implant designed to improve the hearing of adults diagnosed with moderate to profound sensorineural hearing loss. Unlike existing traditional cochlear implants that are partially implanted and have an external microphone and processor, if approved by the FDA, the Acclaim cochlear implant would be the first cochlear implant without any external components to wear, so there would be nothing to lose or damage. Because the Acclaim cochlear implant is a fully implanted device, it remains active all day and night and delivers hearing all the time. People with significant hearing loss who are candidates for cochlear implants often delay or avoid taking advantage of cochlear implant technology altogether in part because of the required external components and associated disadvantages.

The Acclaim cochlear implant leverages the novel sensor technology from Envoy Medical’s Esteem fully implanted active middle ear implant (FI-AMEI) for adults diagnosed with moderate to severe sensorineural hearing loss. The Esteem hearing implant was FDA-approved in 2010, and over a decade’s worth of performance and reliability data continue to validate Envoy Medical’s sensor as the current “gold standard” for fully implanted hearing implants. Designed to overcome the limitations of current hearing devices that rely on external devices and microphones, Envoy Medical’s novel sensor leverages the natural anatomy of the ear to capture sound and convert it into electrical signals that are used by the implant to address hearing loss. The Acclaim cochlear implant received Breakthrough Device Designation status from the FDA and is currently under development.

For more information, please visit: https://www.envoymedical.com/acclaim-...

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