Company Profile
Envoy Medical, Inc. is a US-based manufacturer of fully implanted hearing devices, headquartered in White Bear Lake, Minnesota, USA. Founded in 2006 (predecessor research dating to 1995), the company operates as an independent publicly traded entity listed on NASDAQ: COCH, serving otology and audiology centers across the United States and Europe. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and quality of life.
Core Products & Technologies
Fully Implanted Active Middle Ear Implant
• Esteem FI-AMEI: The only FDA-approved, fully implanted active middle ear implant for adults with moderate to severe sensorineural hearing loss, offering 24/7 hearing using the ear's natural anatomy without externally worn components or ear canal insertion; commercially available in the US since 2010
Investigational Fully Implanted Cochlear Implant
• Acclaim Cochlear Implant: First-of-its-kind fully implanted cochlear implant designed for severe to profound sensorineural hearing loss, leveraging a proprietary piezoelectric sensor that uses the ear's natural anatomy to capture sound instead of an external microphone; no visible hardware, no external processor, and no magnets
• Rechargeable Battery System: Large-capacity internal battery providing approximately five days of use between recharges, with replacement required roughly once every 10 years
• MRI Compatibility: Designed to be MRI compatible without magnet-related restrictions
Digital & Clinical Ecosystem
• Esteem Personal Programmer: External activation and programming device for initial setup; not required for daily use once activated
• Clinical Trial Network: Seven top-tier cochlear implant centers across the US conducting the pivotal Acclaim trial
Market Position & Certifications
Envoy Medical holds a pioneering position as the only company with an FDA-approved fully implanted hearing device and a fully implanted cochlear implant in pivotal trials, competing with Cochlear Ltd. and Advanced Bionics (Sonova) in the broader implantable hearing market. Key strengths include:
• 15+ years of fully implanted hearing device commercial heritage with the Esteem platform
• Sensor technology leadership: Proprietary implanted piezoelectric sensor validated as the "gold standard" for fully implanted hearing implants
• Regulatory milestones: Esteem FDA approved (2010); Acclaim FDA Breakthrough Device Designation (2019) and IDE approval (2024)
• Intellectual property: 47 patents across North America, Europe, Asia, and Australia as of February 2026, including US Patent No. 12,544,564 for cochlear implant signal processing and Hong Kong patents for combination hearing aid/cochlear implant systems
• Clinical validation: Over 900 Esteem implants worldwide; Acclaim pivotal trial fully enrolled with 56 participants as of March 2026, all patients through activation as of April 2026
Corporate Timeline
1995 — Predecessor research begins on fully implanted hearing sensor technology
2001 — First in-human feasibility study conducted
2004 — European clinical trials initiated for Esteem
2006 — Company rebranded to Envoy Medical; CE Mark obtained for Esteem
2010 — Esteem receives FDA approval, becoming the first fully implanted hearing device available in the US
2019 — Acclaim cochlear implant granted FDA Breakthrough Device Designation
2022 — Acclaim receives Investigational Device Exemption (IDE) for feasibility study
2024 — FDA approves IDE for Acclaim pivotal trial; trial sites selected
2025 — Pivotal trial enrollment begins; first 10-patient data submitted to FDA enabling trial expansion; extinguished over USD 32 million in debt; Nasdaq grants continued listing extension to February 23, 2026
2026 — February: Closed upsized USD 78 million public offering led by Nantahala Capital; global IP portfolio expanded to 47 patents. March: Pivotal trial fully enrolled (56 patients). April: All 56 patients through activation; first three patients complete 12-month endpoint; Chas McKhann appointed to board; anticipated PMA submission to FDA in Q2 2027
Target Markets & Applications
• Moderate to Severe Sensorineural Hearing Loss: Esteem FI-AMEI for adults seeking invisible, 24/7 hearing without daily device management
• Severe to Profound Sensorineural Hearing Loss: Acclaim cochlear implant for adults who are candidates for cochlear implantation but prefer a fully internal, discreet solution
• Otolaryngology ＆ Neurotology Practices: Surgical implantation and long-term follow-up care at specialized ENT centers
• Patient Populations Stigmatized by External Devices: Individuals avoiding traditional cochlear implants due to visible external processors and social stigma
Contact Information
Global Headquarters
Address: 4875 White Bear Parkway, White Bear Lake, MN 55110, USA
Tel: +1-877-900-3277
Website: envoymedical.com
Investor Relations
Stock: NASDAQ: COCH
Website: ir.envoymedical.com
Email: Envoy@kcsa.com (add COCH in subject line for distribution list)
