Sam Brusco, Associate Editor06.21.22
Hearing health company Envoy Medical has earned U.S. Food and Drug Administration (FDA) approval for the Investigational Device Exemption (IDE) trial of its Acclaim cochlear implant.
The single-center early feasibility study of Acclaim will occur at the Mayo Clinic in Rochester, Minn. Unlike current available cochlear implants, Acclaim does not have externally worn parts. A unique sensor leverages the ear’s natural anatomy to capture sound.
According to a clinical study, potential recipients often wait longer than advised to receive existing partially implanted cochlear implants, and an often-cited reason was the amount of external hardware.
“We believe that a fully implanted cochlear implant may increase their use among millions of adults with significant hearing loss,” Brent Lucas, CEO of Envoy Medical told the press. “This study is the first step in evaluating the safety and effectiveness of the fully implanted Acclaim cochlear implant, putting us closer towards potentially filling a large unmet need in hearing loss technology.”
Acclaim was granted FDA breakthrough status in 2019. If approved, it will be the first cochlear implant designed for full implantation and use the ear—not a microphone—to pick up sound.
The single-center early feasibility study of Acclaim will occur at the Mayo Clinic in Rochester, Minn. Unlike current available cochlear implants, Acclaim does not have externally worn parts. A unique sensor leverages the ear’s natural anatomy to capture sound.
According to a clinical study, potential recipients often wait longer than advised to receive existing partially implanted cochlear implants, and an often-cited reason was the amount of external hardware.
“We believe that a fully implanted cochlear implant may increase their use among millions of adults with significant hearing loss,” Brent Lucas, CEO of Envoy Medical told the press. “This study is the first step in evaluating the safety and effectiveness of the fully implanted Acclaim cochlear implant, putting us closer towards potentially filling a large unmet need in hearing loss technology.”
Acclaim was granted FDA breakthrough status in 2019. If approved, it will be the first cochlear implant designed for full implantation and use the ear—not a microphone—to pick up sound.