根据早期的积极结果, 美国食品和药物管理局批准了Envoy医疗公司进行全植入式耳植入试验. Envoy Medical got FDA go-ahead to advance its fully implanted cochlear implant trial, based on positive early results.

根据10名患者的积极三个月数据,Envoy Medical获得FDA批准,将其全植入的Acclaim耳植入器的关键试验推向最后阶段,没有严重不良事件. Envoy Medical received FDA approval to move its pivotal trial for the fully implanted Acclaim cochlear implant to the final stage, based on positive three-month data from 10 patients with no serious adverse events. 批准时间加快了3至6个月,现在预计到2026年初将实现全部入学。 The approval accelerates the timeline by three to six months, with full enrollment now expected by early 2026. 由于进展更快、效率提高,该公司资本需求也减少了1 000万至1 500万美元,偿还了3 200万美元的债务,并宣布了董事会变更,包括Glen Taylor在20年后离职。 The company also reduced its capital needs by $10–15 million due to faster progress and improved efficiency, retired $32 million in debt, and announced board changes, including the departure of Glen Taylor after 20 years.