Envoy Medical Corporation
Envoy Medical is dedicated to creating innovative, life-changing hearing technologies, including fully implanted devices like the Esteem® active middle ear implant and the investigational Acclaim® cochlear implant. Founded in 1995, the company aims to improve access, usability, and quality of life for people with hearing loss through advanced solutions and ongoing research.
Industries
Nr. of Employees
medium (51-250)
Envoy Medical Corporation
4875 White Bear Parkway, White Bear Lake, MN 55110
Patents
Products
Fully implanted active middle ear implant (marketed for adults)
A surgically implanted active middle-ear device that uses a sensor mechanically coupled to the ossicular chain and an implanted sound processor and driver to provide continuous hearing without external components.
Fully implanted cochlear implant (investigational)
An investigational cochlear implant system that uses an implanted piezoelectric sensor to capture natural ear vibrations and an implanted electrode array to stimulate the cochlea; currently studied under early-feasibility and pivotal clinical trials.
Fully implanted active middle ear implant (marketed for adults)
A surgically implanted active middle-ear device that uses a sensor mechanically coupled to the ossicular chain and an implanted sound processor and driver to provide continuous hearing without external components.
Fully implanted cochlear implant (investigational)
An investigational cochlear implant system that uses an implanted piezoelectric sensor to capture natural ear vibrations and an implanted electrode array to stimulate the cochlea; currently studied under early-feasibility and pivotal clinical trials.
Services
Protocol development, site activation, patient eligibility screening, and operational management for early feasibility and pivotal clinical studies of implantable hearing devices.
Provision of audiological evaluation workflows and tools to identify candidates for middle-ear and cochlear implant procedures, including standardized audiograms and imaging requirements.
Clinical guidance on implantation procedures, typical operative workflow, expected recovery and device activation/programming timelines for implantable hearing devices.
Ongoing customer support including device troubleshooting, battery replacement scheduling, and educational resources for implanted device recipients.
Educational materials for clinicians about implantable hearing solutions and advocacy initiatives aimed at clarifying payer coverage and access.
Protocol development, site activation, patient eligibility screening, and operational management for early feasibility and pivotal clinical studies of implantable hearing devices.
Provision of audiological evaluation workflows and tools to identify candidates for middle-ear and cochlear implant procedures, including standardized audiograms and imaging requirements.
Clinical guidance on implantation procedures, typical operative workflow, expected recovery and device activation/programming timelines for implantable hearing devices.
Ongoing customer support including device troubleshooting, battery replacement scheduling, and educational resources for implanted device recipients.
Educational materials for clinicians about implantable hearing solutions and advocacy initiatives aimed at clarifying payer coverage and access.
Expertise Areas
- Implantable hearing device development
- Clinical trial management for implantable devices
- Audiology diagnostics and candidacy assessment
- Regulatory strategy and submissions (IDE, Breakthrough Device/EFS)
Key Technologies
- Implanted piezoelectric sensors
- Implanted sound processors
- Implanted mechanical/electrical transducers coupled to ossicular chain
- Implanted electrode arrays for cochlear stimulation
News & Updates
Envoy Medical has received FDA review to begin a pivotal clinical study for the Acclaim cochlear implant.
The Acclaim® Pivotal Trial received IRB approval at the protocol level on Feb 04, 2025.
The FDA has expanded candidacy guidelines for cochlear implants, increasing access for patients.
Envoy Medical discusses the connections between hearing health and Earth Day.
A detailed history of cochlear implant development, from early experiments to modern devices.
An exploration of the challenges faced in bringing cochlear implants to market and gaining acceptance.
Envoy Medical has received FDA review to begin a pivotal clinical study for the Acclaim cochlear implant.
The Acclaim® Pivotal Trial received IRB approval at the protocol level on Feb 04, 2025.
The FDA has expanded candidacy guidelines for cochlear implants, increasing access for patients.
Envoy Medical discusses the connections between hearing health and Earth Day.
A detailed history of cochlear implant development, from early experiments to modern devices.
An exploration of the challenges faced in bringing cochlear implants to market and gaining acceptance.