Full Press Release Details
Bipartisan Senate Bill Seeks to Clarify
that Implanted Active Middle Ear Hearing Devices are Prosthetics, Not Hearing Aids, Making Them Eligible for Medicare Coverage
Envoy Medical's FDA-Approved Esteem
Fully Implanted Active Middle Ear Hearing Device May Now Have an Opportunity to be a Coverable Benefit
WHITE BEAR LAKE, Minnesota - July 31, 2024 - Envoy
Medical , Inc. ("Envoy Medical") (NASDAQ: "COCH"), a hearing health company focused on fully implanted hearing
systems, today announces its support for a new bipartisan Senate bill, titled the Hearing Device Coverage Clarification Act (S.4829),
which seeks to clarify that implanted active middle ear hearing devices should be viewed as prosthetics and not subject to the current
Medicare hearing aid coverage exclusion. Both the House and Senate now have introduced legislation addressing implanted active middle
hearing devices, which Envoy Medical believes will increase the chances of meaningful legislation moving forward and becoming law.
The legislation was introduced on July 29th in the U.S.
Senate by Senators Amy Klobuchar (D-MN) and James Lankford (R-OK). It is expected to gain additional bipartisan support following its
"The bipartisan Hearing Device Coverage Clarification Act
is a huge step forward for patients with significant hearing loss who may benefit from solutions that are beyond hearing aids,"
said Envoy Medical CEO Brent Lucas. "We know Medicare beneficiaries and their loved ones will be grateful to learn that Senators
Klobuchar and Lankford are committed to clarifying that implanted active middle ear hearing devices are not hearing aids and should qualify
to be coverable by Medicare as is already the case with other implanted hearing prosthetics."
Envoy Medical is one of the few companies worldwide that has an implanted
active middle ear implant, and currently the only company that has an FDA-approved, fully implanted active middle ear hearing device.
"We believe that passage of the Hearing Device Coverage Clarification
Act will not only provide access to an important technology, but also result in more competition and more innovation. Envoy Medical
is just one of many companies that would begin to reinvest into the implanted active middle ear hearing device segment," Lucas added.
"That would mean more innovation, more competition, more well-paying jobs in the U.S., and, most importantly, more solutions available
to the nearly 40 million Americans who suffer from disabling hearing loss."
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
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
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 potential for passage of legislation related to reimbursement
for active middle ear hearing devices; the impact that such proposed legislation might have 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 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.