The Esteem® device is the only totally implantable active middle ear implant with FDA Approval, allowing the Company to be the first to capitalize on the new codes
WHITE BEAR LAKE, Minnesota, Oct. 22, 2024 (GLOBE NEWSWIRE) -- Envoy Medical, Inc. (NASDAQ: COCH), a market leader in fully implanted hearing devices, today announced that the American Medical Association (AMA) Current Procedural Terminology (CPT) Editorial Panel has approved five Category III CPT codes for totally implantable active middle ear implants (AMEI), a crucial development for the Company’s already FDA-approved Esteem® product.
This marks the first time that there will be CPT codes for totally implantable active middle ear hearing implants like the Esteem® device. The previous lack of CPT codes effectively limited market adoption of and prevented access to these groundbreaking, fully implanted hearing devices. With a new set of CPT codes, a path to reimbursement for the breakthrough Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI) may begin to take shape.
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.
“Today’s announcement is a seminal moment for Envoy Medical and one that we will work to capitalize on for patients suffering with hearing loss who want access to groundbreaking technologies,” said Brent Lucas, CEO of Envoy Medical, “We have a breakthrough hearing device in our Esteem® fully implanted active middle ear implant. We know it is a device more people with hearing loss want to pursue. Today brings us one step closer to altering the hearing healthcare landscape by providing hearing loss patients with another viable solution.”
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.
“The Esteem® product is a viable hearing solution for the right candidate and we look forward to reinvigorating our efforts around this product now that the codes have been approved,” continued Lucas. “We have some exciting ideas about improvements to the Esteem® device and look forward to furthering our lead in fully implanted hearing technologies. We will continue to act as a disrupter and push the industry forward, which we believe will lead to more innovation and meaningful change.”
Category III codes that were approved at the September 2024 meeting (found here) will be posted to the AMA CPT website by January 1, 2025 with an effective implementation date of July 1, 2025.
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.
About the Fully Implanted Acclaim® Cochlear Implant
We believe the fully implanted Acclaim Cochlear Implant (“Acclaim CI”) will be a first-of-its-kind fully implanted cochlear implant. 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. We believe the Acclaim CI was the first hearing-focused device to receive Breakthrough Device Designation.
CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.
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 future market trading performance of our Class A Common Stock; the future size of the market for our products; the performance and benefits of our products in comparison to competitor products; the benefits of intellectual property developed by Envoy; the impact of CPT codes for active middle ear hearing devices on reimbursement for our on the hearing health market, reimbursement for the Esteem FI-AMEI device, the further development of the Esteem FI-AMEI device, and the Envoy Medical business; and future market conditions or economic performance, as well as 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 April 1, 2024, 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.
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Investor Contact:
CORE IR
516-222-2560
investorrelations@envoymedical.com
