Company Overview
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.
*Once activated, the external Esteem Personal Programmer is not required for daily use.
CAUTION: The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.
The Investment Opportunity
Hearing loss is an all day, everyday problem. We have all day, everyday solutions.
Currently, there are no other fully implanted, full-time hearing treatments available for adults diagnosed with sensorineural (nerve-related) hearing loss.
Our novel implanted piezoelectric sensor uses the ear’s natural anatomy to capture sound as it enters the outer and middle ear. Sound is therefore not artificially distorted as is common with external microphone technology found in currently available traditional hearing devices such as hearing aids and cochlear implants.
48M
An estimated 48 million Americans currently experience hearing loss
$84B
Untapped market for cochlear implants in the US
S2N Market Model prepared for Envoy Medical Corporation Assumes device price of ~$30,000 for 2.8M U.S. population of potential candidates for cochlear implants
2.8M
Adults in the US who may be eligible for cochlear implants
1. Goman, Adele M., and Frank R. Lin. "Prevalence of hearing loss by severity in the United States." American journal of public health 106.10 (2016): 1820-1822.; Goman, Adele M., Nicholas S. Reed, and Frank R. Lin. "Addressing estimated hearing loss in adults in 2060." JAMA Otolaryngology–Head & Neck Surgery 143.7 (2017): 733-734
~5%-8%
Of those eligible for cochlear implants actually receive them
Cochlear Limited Annual Report
Growing Market Demand
Approximately 25% of people over the age of 60 have "disabling hearing loss," a figure that increases to 70% for those in their 70s.
(1) World report on hearing. Geneva: World Health Organization; 2021. License: CC BY-NC-SA 3.0 IGO. (2)
(2) “Disabling hearing” refers to a level of hearing loss that is 35 decibels (dB) or more in the better hearing ear
FDA-Approved Innovation
Envoy Medical’s Esteem fully implanted* active middle ear implant (FI-AMEI) is the first and ONLY FDA -approved (2010) fully implanted hearing device for adults with moderate to severe sensorineural hearing loss.
Innovative Technology
Our novel piezioelectric sensor technology is designed to ultilize the ear’s natural anatomy instead of relying on a conventional external microphone to capture sound.
*Once activated, the external Esteem Personal Programmer is not required for daily use.
Revolutionizing Hearing Health
Our novel implanted piezoelectric sensor uses the ear’s natural anatomy to capture sound as it enters the outer and middle ear. Sound is therefore not artificially distorted as is common with external microphone technology found in currently available traditional hearing devices such as hearing aids and cochlear implants.
Esteem® Fully* Implanted Active Middle Ear Implant-AMEI:
The Esteem® FI-AMEI is the world's first and only FDA – approved fully implanted hearing device for adults with moderate to severe sensorineural hearing loss.
*Once activated, the external Esteem Personal Programmer is not required for daily use.
- No External Components: The Esteem implant doesn't require any externally worn components in the ear canal or elsewhere to hear.
- Continuous Hearing 24/7: Users can enjoy full-time hearing, all day and all night.
- Long-Lasting Battery: The Esteem implant has a battery that last years.
- No Daily Maintenance: The Esteem implant requires no daily maintenance.
Investigational Acclaim® Fully implanted Cochlear Implant:
Envoy Medical is developing and has recently received IDE approval from the FDA to begin a pivotal clinical study for a new first-of-its kind, fully implanted cochlear implant, the Acclaim Cochlear Implant.
- Designed to function in environments not ideally suited for external components.
- Designed to alleviate the burden and discomfort of wearing external components all waking hours.
- Designed to use an implanted rechargeable battery intended to last several days between charges.
- Designed without an external artificial microphone. The device is intended to allow the ear’s natural anatomy to pick up sound similar to the way nature intended.
For illustrative purposes only, and may not be indicative of individual characteristics, size, placement, functionality, or use.
CAUTION: The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.
Fully Implanted Cochlear Implant Trial
Patient (Michael) - Envoy Medical
CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use.
For captions please click CC on the menu bar.
CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use.
Michael is a patient in the Early Feasibility Trial for the fully implanted Acclaim® cochlear implant by Envoy Medical (www.envoymedical.com). In this video, recorded as part of the investigational early feasibility clinical trial's protocol, he shares some of his experiences with the intent and understanding that it will be shared publicly.
The information presented or discussed is for general educational purposes only and may not be representative of all or typical patient outcomes. It is not intended to be a substitute for professional medical advice and should not be interpreted to contain diagnostic or treatment recommendations. Each person’s situation is unique, and risks, outcomes, experiences, and results may vary. You should talk to your healthcare professional about important safety information, risks, options, and what may be right for you.
These individuals received reimbursement from Envoy Medical for travel costs and received their device at no cost through participation in an early feasibility clinical study. They were not paid for sharing their experience.
CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use.
©2025 Envoy Medical. All rights reserved. Acclaim, Envoy, and Envoy Medical are registered trademarks of Envoy Medical Corporation.
Shareholder Resources
Investor Presentations
Download our Investor Presentation.
Financial Reports
Review our SEC filings, annual and quarterly statements
Investor Relations Contact
Investor Relations
For Media Inquiries:
Press Releases
Hearing Device Coverage Clarification Act Reintroduced in House and Senate
Seek to clarify that certain hearing implants are prosthetics and therefore not subject to the hearing aid coverage exclusion, allowing for potential Medicare coverage White Bear Lake, Minnesota--(Newsfile Corp. - March 17, 2025) - Envoy Medical®,
Read More
Envoy Medical Secures $10 Million in Funding to Advance Pivotal Clinical Trial of Breakthrough Hearing Device
Billionaire Entrepreneur Glen Taylor, the Company's Largest Shareholder, Continues to Invest Significant Capital into the Company Furthering Its Progress White Bear Lake, Minnesota--(Newsfile Corp. - March 12, 2025) - Envoy Medical®, Inc. (NASDAQ:
Read More
Envoy Medical Secures $10 Million in Funding to Advance Pivotal Clinical Trial of Breakthrough Hearing Device
Envoy Medical Secures $10 Million in Funding to Advance Pivotal Clinical Trial of Breakthrough Hearing Device
Read More
Company Media Coverage
Follow Envoy Medical's latest appearances and coverage across major media outlets.
Implantable Hearing Devices
Brent Lucas, CEO of Envoy Medical, discusses hearing loss as an "invisible disability," the rise of fully implanted hearing devices, and how Apple’s AirPods® Pro 2 is shaking up the industry.
*AirPods is a registered trademark of Apple Inc., registered in the U.S. and other countries and regions.
March 13, 2025
Smart Money Circle Podcast
This CEO Is Helping People Hear Better- Meet Brent Lucas CEO Envoy Medical $COCH
March 4, 2025
CEO Brent Lucas Discusses Regulation, Innovation, and the Road to Fully Implantable Hearing Devices On “This Week in Hearing”, with Hearing Health Advocate and author Shari Eberts
February 17, 2025
* CAUTION: The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by federal (or United States) law to investigational use.
The materials and resources presented are intended to be an educational resource for general purposes only. They are not intended to constitute medical or business advice or in any way replace the independent medical judgment of a trained and licensed physician with respect to any patient needs or circumstances. The information presented or discussed may not be representative of all patient outcomes. Each person’s situation is unique and risks, outcomes, experience and results may vary. Please see complete product instructions for use, including all product indications, contraindications, precautions and warnings.
This website 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 Acclaim CI being the first
to market fully implanted cochlear implant, the timing of IRB
approvals, site activations, enrollment, and beginning of Envoy
Medical’s clinical trial, the timing of and FDA’s position related
to expanding the clinical trial to full cohort, the timing and
results of clinical trials of the Acclaim CI, and the participation
of any institution in such trials; 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 on this website 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.