Envoy Medical Hits 56-Patient Enrollment Milestone in Acclaim Trial
Envoy Medical enrolled the 56th and final patient in its U.S. pivotal trial of the Acclaim fully implanted cochlear implant, becoming the first to complete enrollment for this novel device. The trial will collect 12-month follow-up data from all participants before submitting a PMA application to the FDA.
1. Completion of Pivotal Trial Enrollment
Envoy Medical has successfully implanted its investigational Acclaim cochlear implant in the 56th and final participant of its U.S. pivotal trial, marking the first time a fully implanted cochlear device has reached full enrollment in a pivotal study.
2. Next Steps Toward FDA Approval
With enrollment complete, the study will proceed through scheduled follow-up visits to gather 12-month safety and efficacy data from all participants, after which the company plans to compile results for a PMA submission to the FDA.
3. Differentiation and Market Potential
The Acclaim cochlear implant uses a fully implanted sensor that leverages natural ear anatomy to capture sound, eliminating external processors and addressing patient stigma, potentially expanding the addressable market to adults previously reluctant to adopt cochlear implants.