White Bear Lake, Minnesota--(Newsfile Corp. - February 24, 2025) - Envoy Medical®, Inc. (NASDAQ: COCH) ("Envoy Medical"), a hearing health company focused on providing hearing loss sufferers with innovative solutions today announces the successful enrollment of the first two participants in its pivotal clinical study. The purpose of the study is to investigate the safety and efficacy of the fully implanted Acclaim® cochlear implant and support its eventual premarket approval (PMA) application. If successful, the fully implanted Acclaim® cochlear implant could represent a paradigm shift in the cochlear implant industry and provide a significant business opportunity for Envoy Medical.
"We are excited to be underway with the highly-anticipated pivotal clinical study of the fully implanted Acclaim® cochlear implant," said Brent Lucas, CEO of Envoy Medical, "The high level of excitement around our fully implanted cochlear implant was expected, but it is still incredibly validating to hear study sites report a great deal of interest from potential candidates. It appears, perhaps unsurprisingly, that many potential cochlear implant candidates would prefer a cochlear implant that can function without bulky externals."
Both study participants were implanted at Ear and Hearing | Center for Neurosciences in Tucson, Arizona by Dr. Abraham Jacob.
"Hearing loss is the most common human sensory disability and a modifiable risk factor for dementia," said Dr. Jacob, "With no external processor and the potential for always-on hearing, the successful implantation of two patients at our center sets the fully implanted Acclaim cochlear implant system as a new benchmark within the hearing healthcare space."
In addition to the Ear and Hearing | Center for Neurosciences in Tucson, Arizona, six other investigational sites were selected to be part of the study. A full list of investigational sites and additional information on the Acclaim® pivotal clinical study can be found HERE.
The fully implanted Acclaim® cochlear implant received Breakthrough Device Designation from the FDA in 2019 and was first implanted in three participants during an early feasibility study (EFS) at Mayo Clinic in Rochester, Minnesota in 2022.
"Over the last two years, we have learned a great deal from our early feasibility study and have been able to implement several device modifications for this pivotal clinical trial," said Lucas, "We strongly believe our fundamental design architecture is the right way to approach fully implanted cochlear implants and may provide our device with several competitive advantages, but as a responsible medical device company, we will seek ways to continuously improve what is already a breakthrough device."
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.
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 ability to obtain additional patents and develop future products or product improvements, the Acclaim CI being the first to market fully implanted cochlear implant, product and component availability and performance, the timing and results of clinical trials of the Acclaim CI, and enrollment and the participation of any institution in such trials; the safety, performance, and market acceptance of the Acclaim CI; the size of Envoy Medical's addressable market, operational performance, future market conditions or economic performance and developments in the capital and credit markets 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 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.
