---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-096845"
form_type: "8-K"
ticker: "COCH"
cik: "0001840877"
company_name: "Envoy Medical, Inc."
filed_at: "2025-10-07T23:59:59+00:00"
generated_at: "2026-05-17T04:28:59.196646+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Envoy Medical gets FDA nod to expand pivotal Acclaim cochlear implant trial to final stage

## Summary
- FDA approved expansion based on 3-month data from first 10 patients; no SAEs or UADEs reported.
- Final stage will add 46 participants across 7 U.S. sites; full enrollment expected by early 2026.
- Timeline shortened by 3–6 months, reducing anticipated capital need by $10–$15 million.
- Preliminary data showed Acclaim can achieve effectiveness for proposed intended use in cochlear-implant-only condition.
- Company believes fully implanted design addresses 95% of eligible adults who have not received a cochlear implant.

## SEC filing metadata
- accession: 0001213900-25-096845
- form_type: 8-K
- ticker: COCH
- cik: 0001840877
- company_name: Envoy Medical, Inc.
- filed_at: 2025-10-07T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1840877/000121390025096845/0001213900-25-096845-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1840877/000121390025096845/ea0260494-8k_envoy.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-096845
- JSON: https://secwatch.observer/filing/0001213900-25-096845.json
- Plain text: https://secwatch.observer/filing/0001213900-25-096845.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.