Envoy Medical puts second Acclaim approval section before FDA, posts $5.2m quarterly loss

Envoy Medical has delivered a further section of the marketing application for its Acclaim hearing implant to the US Food and Drug Administration, and disclosed it on 5 November 2026 with its third-quarter results. The company reported a net loss of $5.2 million for the period. The material provided gives no revenue figure and no commercial launch timetable.

The filing is the second part of a four-part submission. Under the modular route to premarket approval, a sponsor sends sections of its application in stages instead of assembling one complete package. That leaves two sections still to come, and the company has not said when they will be sent. Acclaim is intended for severe to profound sensorineural hearing loss and holds FDA Breakthrough Device designation.

On the clinical side, every one of the 56 people in the pivotal study has now been followed for at least six months. Envoy expects to finish gathering 12-month data early in the second quarter of 2027, which is the next milestone for the dataset behind the application.

The company also gave an early look at efficacy. The first 10 participants showed an average improvement of 38 points on CNC word scores at 12 months. That is a small subset, not the complete pivotal result. Envoy also said the Atlas litigation has been dismissed, without giving further detail in the information available.