Envoy Medical Soars 97% on FDA Nod for Cochlear Implant Trial
Regulator allows final-stage expansion of its fully implanted Acclaim device, potentially shortening the path to commercialization by up to six months.
Shares of Envoy Medical (COCH) skyrocketed over 97% in heavy trading after the hearing health company announced a significant regulatory milestone for its next-generation hearing device. The surge was triggered after the company to advance the pivotal clinical trial for its novel Acclaim cochlear implant.
The Acclaim device represents a potential leap forward in hearing technology as a , eliminating the need for external microphones and processors worn outside the body. This key feature, which aims to improve user quality of life, helped the device secure the FDA's Breakthrough Device Designation back in 2019.
The FDA's latest decision allows Envoy to expand the trial to its second and final stage, adding 46 new participants to the initial 10. This approval came after the initial cohort successfully reached their three-month follow-up milestone with no serious adverse events, demonstrating the device's potential effectiveness and safety.
For investors, the news provides a clearer and potentially faster route to market. Envoy Medical stated the approval is expected to and reduce its projected capital needs by $10-15 million. The market's reaction was immediate and dramatic, with trading volume swelling to more than 300 times its daily average, reflecting strong investor optimism.
While this approval marks a critical step, the company must still complete the expanded trial and submit a premarket approval (PMA) application to the FDA. Envoy expects to achieve full enrollment for the pivotal trial by early 2026. The successful advancement of the Acclaim trial positions the company as a significant innovator in the competitive landscape of hearing loss solutions.