• Envoy Medical in Position to Leverage its Sensor Technology

WHITE BEAR LAKE, MN, June 05, 2024 (GLOBE NEWSWIRE) -- Envoy Medical®, Inc. (“Envoy Medical”) (Nasdaq: COCH) today highlighted a recently published article in the Current Otorhinolaryngology Reports. The article, titled, “Fully Implanted Cochlear Implants,” was authored by Dr. Eric Babajanian, Dr. James Dornhoffer, and Dr. Colin Driscoll from Mayo Clinic in Rochester, Minnesota. Authors describe it as a review of the current state of fully implanted cochlear implants, including some of the challenges, limitations and breakthroughs.

The authors discuss the important influence middle ear implants (MEIs) have had on the development of fully implanted cochlear implants (FICI): “Many of the advancements in this area have contributed to the development of a FICI, primarily with the development of various microphone technologies that bypass the need for a separate external microphone.”

The article goes on to say that Envoy Medical’s fully implanted active middle ear implant (FI-AMEI), the Esteem^® device, is the only fully implanted active middle ear implant currently commercially available. Envoy Medical believes its commercial experience with the Esteem fully implanted sensor technology provides it with an important competitive advantage in the marketplace.

“Envoy Medical is a leader in fully implanted hearing devices and we owe that leadership to our many years of experience with our fully implanted sensor technology,” said Brent T. Lucas, Envoy Medical’s Chief Executive Officer, “We have always believed that leveraging the outer and middle ear anatomy makes a lot more sense than sticking a microphone under the skin somewhere behind the ear.

“One of the benefits of leveraging the outer and middle ear anatomy is that the ear can still be used for other accessories and electronics, including headphones, ear buds, and even hearing aids,” added Lucas.

The article also notes the importance of an implantable power supply for a fully implanted cochlear implant. For its investigational fully implanted Acclaim^® cochlear implant, Envoy Medical chose an architecture with a larger rechargeable battery in the pectoral region, versus a smaller rechargeable battery in the head.

“When faced with design choices, we felt that patients would rather go several days between charges. Our device was designed with patient preference in mind, and I believe we are headed in the right direction,” said Lucas.

The complete article can be found under the citation: Babajanian, E.E., Dornhoffer, J.R. & Driscoll, C.L.W. Fully Implanted Cochlear Implants. Curr Otorhinolaryngol Rep (2024). https://doi.org/10.1007/s40136-024-00507-3.

Author Colin L.W. Driscoll, MD is the principal investigator and Mayo Clinic is the clinical investigation site for the Acclaim® Early Feasibility Study.

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.

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.

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 availability and benefits of future funding, the Acclaim CI being the first to market fully implanted cochlear implant, the timing of Envoy Medical’s IDE submission and beginning of its clinical trial, the impact of proposed legislation on the hearing health market, reimbursement for 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 transactions and 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; 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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