The Esteem(R) device by Envoy Medical is the only totally implantable active middle ear implant with FDA Approval currently on the market
White Bear Lake, Minnesota--(Newsfile Corp. - June 26, 2025) - Envoy Medical, Inc. (NASDAQ: COCH), a revolutionary hearing health company focused on fully implanted hearing devices that leverage the ear's natural anatomy, today announced that five Category III CPT codes for totally implantable active middle ear implants approved by the American Medical Association (AMA) Current Procedural Terminology (CPT) Editorial Panel will be effective on July 1st 2025.
CPT codes are used by healthcare professionals and insurers to identify, track, and pay for medical services and procedures. If a medical service or procedure does not have coding, insurance reimbursement can be challenging.
This marks the first time that there will be CPT codes for totally implantable active middle ear hearing implants like the Company's Esteem® device. The previous lack of CPT codes effectively limited market adoption of and prevented access to these groundbreaking, fully implanted hearing devices. The new set of specific CPT codes further demonstrates the difference between fully implanted active middle ear implants like the Esteem® and other hearing devices.
"Hearing loss patients have long desired more available options to address their hearing loss," said Brent Lucas, CEO of Envoy Medical. "We are focused on bringing innovative and breakthrough hearing devices to market to provide these frustrated patients with clinically relevant solutions. This work also includes advocating for changes to how hearing loss sufferers and their chosen solutions are treated by insurance providers. Obtaining a new set of Category III CPT Codes to cover the procedures related to our Esteem® fully implanted active middle ear implant, for example, is a significant step in establishing more viable options for the right patients."
Category III CPT codes are temporary codes for emerging technologies, services, and procedures. The inclusion of a descriptor and its associated code number in the CPT code set does not represent endorsement by the American Medical Association of any particular diagnostic or therapeutic procedure/service. Inclusion or exclusion of a procedure/service does not imply any health insurance coverage or reimbursement policy.
Lucas continued, "These new codes should also increase the level of competition and innovation within an industry that has long been dominated by a small group of players with a significant vested interest in the status quo. Envoy Medical intends to be a catalyst for change on multiple fronts within the hearing loss industry, and we are not embarrassed to admit it. We are proud to be an American company fighting for more access to innovative solutions for Americans suffering from significant hearing loss."
Individuals interested in learning more about the Category III codes that were approved in September 2024 can view the meeting here.
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 device is powered by a rechargeable battery and has an external charger to charge the internal device when necessary. In addition, patients are given an external remote or programmer to adjust settings or turn the device on or off.
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.
For more information on the trial, investors can visit clinicaltrials.gov or www.envoymedical.com/acclaim-pivotal.
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. Patients are given an external remote or "personal programmer" to adjust volume, switch between hearing profiles, or turn the device on or off.
Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information.
Additional Information and Where to Find It
Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov.
Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-Looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals for future operational improvements and capital investments; the impact of CPT codes for active middle ear hearing devices, changes in reimbursement for the Esteem FI-AMEI device or other changes in reimbursement policies or coverage decisions, changes in the hearing health market, and further development of the Esteem FI-AMEI device; the timing and results of IRB approvals, site documents, logistics or activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI, and the participation or any changes in participation of any subjects, institutions or healthcare professionals in such trials; the Acclaim CI being the first to market fully implanted cochlear implant; the safety, performance, and market acceptance of the Acclaim CI; and any information concerning possible or assumed future operations of Envoy Medical. The forward-looking statements contained in this press release reflect Envoy Medical's current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the events described will happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to changes in the market price of shares of Envoy Medical's Class A Common Stock; changes in or removal of Envoy Medical's shares inclusion in any index; Envoy Medical's success in retaining or recruiting, or changes required in, its officers, key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of Envoy Medical products; competition in the medical device industry, and the failure to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions in relationships with Envoy Medical's suppliers, or disruptions in Envoy Medical's own production capabilities for some of the key components and materials of its products; changes in the need for capital and the availability of financing and capital to fund these needs; changes in interest rates or rates of inflation; legal, regulatory and other proceedings could be costly and time-consuming to defend; changes in applicable laws or regulations, or the application thereof on Envoy Medical; a loss of any of Envoy Medical's key intellectual property rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts; and other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward Looking Statements" in the Annual Report on Form 10-K filed by Envoy Medical on March 31, 2025, and in other reports Envoy Medical files, with the SEC. If any of these risks materialize or Envoy Medical's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical's good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to Envoy Medical.
Investor Contact:
Phil Carlson
KCSA Strategic Communications
O: 212.896.1233
E: pcarlson@kcsa.com
SOURCE: Envoy Medical, Inc.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/256876
CPT codes are used by healthcare professionals and insurers to identify, track, and pay for medical services and procedures. If a medical service or procedure does not have coding, insurance reimbursement can be challenging.
This marks the first time that there will be CPT codes for totally implantable active middle ear hearing implants like the Company's Esteem® device. The previous lack of CPT codes effectively limited market adoption of and prevented access to these groundbreaking, fully implanted hearing devices. The new set of specific CPT codes further demonstrates the difference between fully implanted active middle ear implants like the Esteem® and other hearing devices.
"Hearing loss patients have long desired more available options to address their hearing loss," said Brent Lucas, CEO of Envoy Medical. "We are focused on bringing innovative and breakthrough hearing devices to market to provide these frustrated patients with clinically relevant solutions. This work also includes advocating for changes to how hearing loss sufferers and their chosen solutions are treated by insurance providers. Obtaining a new set of Category III CPT Codes to cover the procedures related to our Esteem® fully implanted active middle ear implant, for example, is a significant step in establishing more viable options for the right patients."
Category III CPT codes are temporary codes for emerging technologies, services, and procedures. The inclusion of a descriptor and its associated code number in the CPT code set does not represent endorsement by the American Medical Association of any particular diagnostic or therapeutic procedure/service. Inclusion or exclusion of a procedure/service does not imply any health insurance coverage or reimbursement policy.
Lucas continued, "These new codes should also increase the level of competition and innovation within an industry that has long been dominated by a small group of players with a significant vested interest in the status quo. Envoy Medical intends to be a catalyst for change on multiple fronts within the hearing loss industry, and we are not embarrassed to admit it. We are proud to be an American company fighting for more access to innovative solutions for Americans suffering from significant hearing loss."
Individuals interested in learning more about the Category III codes that were approved in September 2024 can view the meeting here.
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 device is powered by a rechargeable battery and has an external charger to charge the internal device when necessary. In addition, patients are given an external remote or programmer to adjust settings or turn the device on or off.
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.
For more information on the trial, investors can visit clinicaltrials.gov or www.envoymedical.com/acclaim-pivotal.
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. Patients are given an external remote or "personal programmer" to adjust volume, switch between hearing profiles, or turn the device on or off.
Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information.
Additional Information and Where to Find It
Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov.
Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-Looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals for future operational improvements and capital investments; the impact of CPT codes for active middle ear hearing devices, changes in reimbursement for the Esteem FI-AMEI device or other changes in reimbursement policies or coverage decisions, changes in the hearing health market, and further development of the Esteem FI-AMEI device; the timing and results of IRB approvals, site documents, logistics or activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI, and the participation or any changes in participation of any subjects, institutions or healthcare professionals in such trials; the Acclaim CI being the first to market fully implanted cochlear implant; the safety, performance, and market acceptance of the Acclaim CI; and any information concerning possible or assumed future operations of Envoy Medical. The forward-looking statements contained in this press release reflect Envoy Medical's current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the events described will happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to changes in the market price of shares of Envoy Medical's Class A Common Stock; changes in or removal of Envoy Medical's shares inclusion in any index; Envoy Medical's success in retaining or recruiting, or changes required in, its officers, key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of Envoy Medical products; competition in the medical device industry, and the failure to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions in relationships with Envoy Medical's suppliers, or disruptions in Envoy Medical's own production capabilities for some of the key components and materials of its products; changes in the need for capital and the availability of financing and capital to fund these needs; changes in interest rates or rates of inflation; legal, regulatory and other proceedings could be costly and time-consuming to defend; changes in applicable laws or regulations, or the application thereof on Envoy Medical; a loss of any of Envoy Medical's key intellectual property rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts; and other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward Looking Statements" in the Annual Report on Form 10-K filed by Envoy Medical on March 31, 2025, and in other reports Envoy Medical files, with the SEC. If any of these risks materialize or Envoy Medical's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical's good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to Envoy Medical.
Investor Contact:
Phil Carlson
KCSA Strategic Communications
O: 212.896.1233
E: pcarlson@kcsa.com
SOURCE: Envoy Medical, Inc.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/256876
