July 2020 White Bear Press
White Bear Lake-based hearing health company Envoy Medical announced its Acclaim cochlear implant is being fast tracked through the Food and Drug Administration (FDA) approval process. The FDA granted Breakthrough Device Designation, which enables expedited review to get the implant to patients faster.
If approved, Acclaim would be the first-of-its-kind cochlear implant with no external components for 24/7 invisible hearing. The company is also celebrating 10 years since FDA approved its fully implanted Esteem osseointegrated active middle ear implant. Technology from that earlier device is being used in the fully implanted Acclaim. The natural anatomy of the ear is used to capture sound and convert it into electrical signals that are used by the invisible 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.
Added Mayo Clinic physician Dr. Colin Driscoll, MD, practicing neurotologist and chair of the department of otolaryngology, “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. 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.”