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The Esteem(R) device by Envoy Medical is the only totally implantable active middle ear implant with FDA Approval currently on the market
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Envoy Medical Successfully Reaches Three-Month Follow-Up Milestone in Clinical Trial of the Acclaim Fully Implanted Cochlear Implant
No Serious Adverse Events or Unanticipated Device Effects Reported; Company Confirms Program Remains On Track
White Bear Lake, Minnesota--(Newsfile Corp. - September 3, 2025) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical"), a hearing health company focused on developing innovative, fully implanted technologies, today announced that the patients in the first stage of its pivotal clinical trial for the investigational Acclaim® fully implanted cochlear implant have successfully reached their three-month follow-up milestone. During this timeframe, no serious adverse events (SAEs) or unanticipated device effects (UADEs) were reported.
Envoy Medical's pivotal trial is designed to evaluate the safety and effectiveness of its Acclaim® fully implanted cochlear implant, an investigational first-of-its-kind device that aims to overcome adoption barriers associated with wearable external hardware in traditional hearing devices. With the pivotal trial progressing as planned, the Company believes it remains on track to achieve subsequent milestones and is targeting a submission for FDA approval in 2027. Successfully reaching this clinical trial milestone adds crucial data to the risk-benefit profile of Envoy Medical's breakthrough device and underscores the Company's progress toward its goal of redefining the standard of care for adults with significant hearing loss with hearing solutions that are fully implanted.
"We continue to be encouraged by the direction and momentum of our pivotal clinical trial," said Brent Lucas, Chief Executive Officer of Envoy Medical. "The absence of any serious adverse events or unanticipated device effects to date gives us an increasing level of confidence as we continue to progress through the clinical trial. We believe reaching this milestone helps support de-risking a fully implanted cochlear implant program and moves us one step closer to PMA submission and meeting our goal of being able to address unmet needs in the highly underpenetrated cochlear implant market."
Envoy Medical believes its investigational fully implanted cochlear implant, the Acclaim® device, is designed to be meaningfully different from any of its competitors' products. The Acclaim® is a breakthrough device that is designed to have the following attributes:
White Bear Lake, Minnesota--(Newsfile Corp. - September 3, 2025) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical"), a hearing health company focused on developing innovative, fully implanted technologies, today announced that the patients in the first stage of its pivotal clinical trial for the investigational Acclaim® fully implanted cochlear implant have successfully reached their three-month follow-up milestone. During this timeframe, no serious adverse events (SAEs) or unanticipated device effects (UADEs) were reported.
Envoy Medical's pivotal trial is designed to evaluate the safety and effectiveness of its Acclaim® fully implanted cochlear implant, an investigational first-of-its-kind device that aims to overcome adoption barriers associated with wearable external hardware in traditional hearing devices. With the pivotal trial progressing as planned, the Company believes it remains on track to achieve subsequent milestones and is targeting a submission for FDA approval in 2027. Successfully reaching this clinical trial milestone adds crucial data to the risk-benefit profile of Envoy Medical's breakthrough device and underscores the Company's progress toward its goal of redefining the standard of care for adults with significant hearing loss with hearing solutions that are fully implanted.
"We continue to be encouraged by the direction and momentum of our pivotal clinical trial," said Brent Lucas, Chief Executive Officer of Envoy Medical. "The absence of any serious adverse events or unanticipated device effects to date gives us an increasing level of confidence as we continue to progress through the clinical trial. We believe reaching this milestone helps support de-risking a fully implanted cochlear implant program and moves us one step closer to PMA submission and meeting our goal of being able to address unmet needs in the highly underpenetrated cochlear implant market."
Envoy Medical believes its investigational fully implanted cochlear implant, the Acclaim® device, is designed to be meaningfully different from any of its competitors' products. The Acclaim® is a breakthrough device that is designed to have the following attributes:
- Invisible Hearing® — With no required externals worn on the ear, the Acclaim® device is designed to allow patients to address their significant hearing loss with discretion.
- No Microphone — The Acclaim® device is designed to use the natural ear, not an external or sub-dermal microphone to capture sound.
- In-Ear Flexibility — Due to the Acclaim® device using the ear to pick up sound (versus an off-the-ear, in-the-ear, or sub-dermal microphone), a patient can still choose to use their ear for an ear-based consumer electronic device (e.g., headphones) or other in-ear accessories. As Artificial Intelligence (AI) improves rapidly and consumer electronics evolve much faster than implanted medical devices, the in-ear flexibility allowed by the Acclaim® device's design may prove to be important to some users who want an option to use ear-worn consumer electronics.
- Long Battery Life — Designed to last several days on one charge, the Acclaim® battery design supports a patient's ability to hear all day, every day without having to worry about daily charging.
- Wireless Updates — The internal components of the Acclaim® device are designed to allow for certain firmware updates, supporting wireless device improvements without surgical intervention.
Mr. Lucas concluded, "While the Acclaim® cochlear implant remains in clinical trials, we believe it has potential to be exceptionally well received by adults with significant hearing loss. We see a future where fully implanted hearing devices become the standard of care, and Envoy Medical is uniquely positioned to be a leader in that transformation. As the only U.S.-based hearing health company solely focused on fully implanted hearing solutions, from the FDA-approved Esteem® active middle ear implant to the investigational, first-of-its-kind Acclaim® cochlear implant, we are committed to redefining what's possible in hearing health. We believe the future of hearing loss treatment is fully implanted."
For more information about Envoy Medical's innovation pipeline and intellectual property portfolio, visit www.envoymedical.com To be added to the Envoy Medical email distribution list, please email Envoy@kcsa.com with COCH in the subject line.
About Envoy Medical, Inc.
Envoy Medical (NASDAQ: COCH) is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life.
About the Fully Implanted Acclaim® Cochlear Implant
We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound.
The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician.
The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.
CAUTION: The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.
About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI)
The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss, allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components, and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing.
*Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.
Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information.
See important information here: https://landing.envoymedical.com/important-information
