RegulatoryCompany release

Envoy Medical submits second PMA module for Acclaim fully implanted cochlear implant

🇺🇸 Envoy Medical, Inc. (COCH) · Thu 05 Nov 2026

The Breakthrough-designated device's pivotal trial has passed six months of follow-up for all 56 participants, with 12-month data collection expected to finish early in Q2 2027.

Envoy Medical has submitted the second of four modules of its modular premarket approval (PMA) application to the US Food and Drug Administration for the Acclaim cochlear implant. The company announced the filing alongside its third-quarter 2026 results on 5 November 2026.

Acclaim is a fully implanted cochlear implant intended for severe to profound sensorineural hearing loss and carries FDA Breakthrough Device designation. In a modular PMA, sponsors send sections of the application in stages rather than as one complete package.

On the clinical side, all 56 participants in the pivotal trial have now passed six-month follow-up. Envoy expects to finish collecting 12-month data early in the second quarter of 2027.

The company also reported that the first 10 participants achieved a mean gain of 38 points on CNC word scores at 12 months. For the third quarter it recorded a net loss of $5.2 million, and it said the Atlas litigation had been dismissed.

What it means for your team

  • The second of four PMA modules is now with FDA, so two modules remain to be submitted; the source gives no timetable for them.
  • Completion of 12-month data collection in early Q2 2027 is the next clinical milestone for the pivotal dataset.
  • The 38-point CNC gain comes from only the first 10 participants, so it should be read as early data rather than the full pivotal result.
  • Teams tracking implantable hearing devices should note that a Breakthrough-designated, fully implanted option is progressing through FDA review.

Company's press release (SEC filing): Envoy Medical, Inc. ↗

Article written by VigiEye from the official source (Envoy Medical, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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