Envoy Medical shares rise 10.38% premarket after Acclaim trial completes 6-month follow-up with no serious adverse events.

Envoy Medical surged 10.38% in premarket trading following the announcement that all 10 patients in its pivotal Acclaim cochlear implant trial completed six-month follow-ups with no serious adverse events. The update reinforced the device’s safety profile, accelerated enrollment, and highlighted trial expansion, aligning with the company’s timeline for FDA submission and commercialization. The news also underscored the Acclaim implant’s Breakthrough Device Designation (2019) and growing confidence in its potential to address unmet needs in hearing health. With no critical safety concerns reported and momentum in enrollment, the development positions Envoy Medical to advance regulatory milestones, driving optimism among investors ahead of potential long-term efficacy data and regulatory filings.