June 2020 Business Wire

envoyEnvoy, a hearing health company focused on providing innovative technologies across the hearing loss spectrum, announced that its fully implanted Acclaim® cochlear implant was granted the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). Unlike existing traditional cochlear implants that are partially implanted and have an external microphone and processor, if approved by the FDA, the Acclaim would be the first-of-its-kind cochlear implant without any external components.

“Patients with significant hearing loss want to hear better but many delay or avoid taking advantage of cochlear implant technology altogether in part because of the required external components,” said Dr. Colin Driscoll, MD, practicing neurotologist and chair of the department of otolaryngology – head and neck surgery at Mayo Clinic in Minnesota. “I am thrilled to see the progress being made by Envoy Medical on the Acclaim cochlear implant because a fully implantable device eliminates this barrier and in addition delivers hearing all the time, day and night. It could be like getting your hearing back.”

Envoy Medical is also celebrating 10 years since FDA approval of its fully implanted Esteem® osseointegrated active middle ear implant (AMEI) for adults diagnosed with moderate to severe sensorineural hearing loss. 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. “Our unique sensor remains a disruptive platform technology that allows us to excel in the development of fully implanted hearing devices, which we believe offer unique benefits and improvements over traditional hearing devices with external components,” said Brent Lucas, CEO of Envoy Medical. “Receiving the Breakthrough Device Designation for our fully implanted Acclaim cochlear implant was an important milestone, one that will help us bring our device to people as quickly and efficiently as we can.

The FDA Breakthrough Devices Program was implemented to expedite the development and review process for medical devices that offer new technology for patients with life-threatening or irreversibly debilitating conditions. This program is designed to ensure patients and healthcare providers have more timely access to vital devices.

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