{"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","discovered_at":"2026-05-14T18:02:40.750844+00:00","generated_at":"2026-05-17T04:28:59.196646+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Envoy Medical gets FDA nod to expand pivotal Acclaim cochlear implant trial to final stage","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-25-096845","json":"https://secwatch.observer/filing/0001213900-25-096845.json","markdown":"https://secwatch.observer/filing/0001213900-25-096845.md","text":"https://secwatch.observer/filing/0001213900-25-096845.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T04:28:59.196646+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}