US EditionEnvoy Medical Selects Study Sites for Trial of Fully Implanted Cochlear Implant
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Envoy Medical Selects Study Sites for Trial of Fully Implanted Cochlear Implant
Summary: Envoy Medical has chosen seven investigational sites for its pivotal clinical trial of the fully implanted Acclaim cochlear implant, with initial patient enrollment set to begin in Q1 2025. Takeaways: FDA-Approved Trial: The U.S. FDA granted Investigational Device Exemption (IDE) approval for the pivotal study of the Acclaim CI in November 2024, following its earlier Breakthrough Device Designation. Innovative Design: Unlike traditiona…
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