Envoy Medical Receives FDA Approval To Initiate Pivotal Clinical Study for Breakthrough Hearing Device
Envoy Medical, Inc. - Class A (COCH)
Company Research
Source: GlobeNewswire
The Acclaim® Fully Implanted Cochlear Implant is differentiated from existing cochlear implants and may offer new option for hearing loss patients WHITE BEAR LAKE, Minnesota, Nov. 01, 2024 (GLOBE NEWSWIRE) -- Envoy Medical®, Inc. (“Envoy Medical”) (NASDAQ: “COCH”), a hearing health company focused on fully implanted hearing systems, today announces that its Investigational Device Exemption (IDE) application for its pivotal study of the Acclaim® Fully Implanted Cochlear Implant has been approved by the U.S. Food and Drug Administration (FDA). The Acclaim® technology includes an implanted sensor designed to leverage the natural anatomy of the ear to capture sound, making it different from existing cochlear implants on the market. “Receiving FDA approval to initiate this pivotal study marks a significant milestone in our efforts to bring this breakthrough hearing device to more people with severe to profound hearing loss,” said Brent Lucas CEO of Envoy Medical. “Currently, it is es
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News
- Envoy Medical Reports Third Quarter 2024 Results and Other Exciting EventsGlobeNewswire
- Envoy Medical’s Fully Implanted Acclaim® Cochlear Implant Highlighted in Peer-Reviewed PublicationGlobeNewswire
- Envoy Medical Receives Another European Patent for its Modular Cochlear Implant SystemGlobeNewswire
- Key Advocates Urge CMS to Clarify that Fully Implanted Active Middle Ear Hearing Devices are Prosthetic Devices for Purposes of Medicare CoverageGlobeNewswire
- Envoy Medical to Present at the LD Micro Main Event XVIIGlobeNewswire
COCH
Analyst Actions
- 9/3/24 - Ascendiant Capital
COCH
Sec Filings
- 11/21/24 - Form 4
- 11/21/24 - Form 4
- 11/20/24 - Form 8-K
- COCH's page on the SEC website