Envoy Medical Secures New Australian Patent for Cochlear Implant Innovation Aimed at Enhancing Input Signal-to-Noise Ratio

Rhea-AI Summary

Envoy Medical (NASDAQ: COCH) announced issuance of Australian Patent No. 2022229818 on October 16, 2025 for a "Cochlear Implant System with Improved Input Signal-To-Noise Ratio." The patent covers a sensor and powered signal modifier that amplifies the input at the source to reduce noise and interference.

The company highlighted its multi‑decade investment (about $300 million), prior FDA Breakthrough Device Designation for the Acclaim cochlear implant, and an ongoing U.S. pivotal clinical trial for the investigational fully implanted cochlear implant.

Positive

• Australian patent No. 2022229818 issued on Oct 16, 2025
• Patent covers input sensor with amplified analog input to reduce noise
• Company cites prior FDA Breakthrough Device Designation for Acclaim
• Ongoing U.S. pivotal clinical trial for investigational cochlear implant

Negative

• Company reports ~$300 million invested to date in technology development
• Device remains investigational and not yet FDA approved for marketing
• Largest competitor is based in Australia, heightening regional competitive risk

News Market Reaction

-4.02%

3 alerts

-4.02% News Effect

-3.1% Trough Tracked

-$968K Valuation Impact

$23M Market Cap

0.2x Rel. Volume

On the day this news was published, COCH declined 4.02%, reflecting a moderate negative market reaction. Argus tracked a trough of -3.1% from its starting point during tracking. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $968K from the company's valuation, bringing the market cap to $23M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Australian Patent Number: No. 2022229818 Patent grant date: October 16, 2025 Development investment: $300 million +1 more

4 metrics

Australian Patent Number No. 2022229818 Australian Patent Office grant

Patent grant date October 16, 2025 Australian patent issuance date

Development investment $300 million Capital invested over decades in fully implanted devices

Breakthrough Designation year 2019 FDA Breakthrough Device Designation for Acclaim cochlear implant

Market Reality Check

Price: $0.4701 Vol: Volume 220,742 is below 2...

low vol

$0.4701 Last Close

Volume Volume 220,742 is below 20-day average of 452,762 (relative volume 0.49). low

Technical Shares at $0.752 are trading below the 200-day MA of $1.25 and 66.58% below the 52-week high.

Peers on Argus

COCH was down 6.63% while momentum peers like ADGM and RBOT showed gains of 20.2...

2 Up

COCH was down 6.63% while momentum peers like ADGM and RBOT showed gains of 20.22% and 7.29%, suggesting stock-specific pressure rather than a broad medical-device selloff.

Historical Context

5 past events · Latest: Dec 10 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 10	Clinical progress	Positive	+3.1%	First activations completed in final stage of pivotal Acclaim trial.
Dec 04	Investor outreach	Positive	+4.5%	Announcement of investor fireside chat with first Acclaim patient.
Dec 02	Patent grant	Positive	-0.5%	Grant of 40th active U.S. patent for stimulation calibration.
Nov 20	Patent grant	Positive	-1.8%	New U.S. patent for system with removable earplug sensor and battery.
Nov 18	Clinical milestone	Positive	+17.5%	First 10 pivotal trial patients reached six‑month follow‑up with no SAEs.

Pattern Detected

Recent positive clinical and patent updates often saw modestly positive or mixed price reactions, with occasional stronger moves on key clinical milestones.

Recent Company History

Over the past month, Envoy Medical has reported multiple milestones around its fully implanted Acclaim cochlear implant and IP portfolio. On Nov 18, a six‑month milestone for the first 10 trial patients with no serious adverse events saw a 17.48% move. Subsequent U.S. patent grants and clinical activation updates around early December produced smaller, mixed reactions between about -1.83% and 4.53%. Today’s Australian patent further expands this IP theme while the share price trades near the lower end of its 52‑week range.

Market Pulse Summary

This announcement adds an Australian patent covering a cochlear implant system designed to improve i...

Analysis

This announcement adds an Australian patent covering a cochlear implant system designed to improve input signal‑to‑noise ratio, reinforcing Envoy Medical’s focus on fully implanted hearing technology. It complements recent U.S. patent grants and ongoing pivotal trial work on the Acclaim device, which holds FDA Breakthrough Device Designation from 2019. Against a backdrop of low share price and Nasdaq compliance pressures, investors may watch future clinical data, additional IP grants, and capital‑raising steps to gauge execution and risk.

Key Terms

cochlear implant, signal-to-noise ratio, breakthrough device designation, pivotal clinical trial, +1 more

5 terms

cochlear implant medical

"fully implanted cochlear implant, and it will continue to make important investments"

A cochlear implant is a surgically implanted medical device that converts sound into electrical signals and stimulates the inner ear to provide a sense of hearing for people with severe hearing loss, working like a tiny radio and wiring that bypasses damaged parts of the ear. Investors track cochlear implants because they involve durable hardware, ongoing service and upgrades, regulatory approvals, reimbursement rules and surgical volumes—factors that drive revenue, margins and long-term market growth.

signal-to-noise ratio technical

"titled "Cochlear Implant System with Improved Input Signal-To-Noise Ratio," covers innovations"

The signal-to-noise ratio measures how much useful information (the signal) stands out from irrelevant or random data (the noise). For investors, a high ratio means price moves, earnings reports or research reliably reflect real value or trends, while a low ratio means it's harder to separate meaningful signals from meaningless fluctuations—like trying to hear a single voice in a crowded room or tune a radio to a clear station, which affects confidence in decisions.

breakthrough device designation regulatory

"We received Breakthrough Device Designation from the FDA for our fully implanted"

A breakthrough device designation is a regulatory program that gives promising medical devices for serious or life‑threatening conditions priority support and faster review from a health authority (e.g., the U.S. FDA). Think of it as a “fast lane” or VIP pass through development and review: it can shorten time to market, lower regulatory uncertainty, and boost a company’s commercial prospects — but it is not an approval by itself.

pivotal clinical trial medical

"is currently under investigation as part of a U.S. based pivotal clinical trial."

A pivotal clinical trial is a late-stage medical study designed to provide the main evidence regulators use to decide whether a drug or medical device can be approved and sold; think of it as the product’s final exam. For investors, the trial’s outcome is critical because a clear pass can unlock regulatory approval, market access and future revenue, while failure can halt commercialization and materially affect a company’s valuation.

subdermal microphone medical

"Our sensor technology is fundamentally different from a subdermal microphone."

A subdermal microphone is a tiny microphone designed to sit just under the skin to detect sounds or vibrations from inside the body or the surrounding environment, often used in medical devices, implants, or specialized wearable tech. For investors it matters because this kind of component can enable new products or services, trigger regulatory and privacy hurdles, and drive manufacturing and clinical costs—much like a new engine that can power novel devices but also carries approval and liability risks.

AI-generated analysis. Not financial advice.

Patent strengthens Company's global intellectual property portfolio and reinforces the Company's commitment to establishing and protecting competitive advantages

White Bear Lake, Minnesota--(Newsfile Corp. - December 16, 2025) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced the issuance of Australian Patent No. 2022229818, granted by the Australian Patent Office on October 16, 2025.

The newly issued patent strengthens the Company's global IP portfolio in an important international market that is also the home country of its largest competitor. The Company remains focused on establishing differentiation within the marketplace and protecting competitive advantages. The Company understands the staggering cost – both in raw capital investment, time, and opportunity cost – it would take a competitor to recreate Envoy Medical's fully implanted cochlear implant, and it will continue to make important investments to further strengthen its technology and product pipeline.

"It has taken Envoy Medical roughly $300 million dollars and a few decades to get to where it is today," said Brent Lucas, Chief Executive Officer of Envoy Medical. "We have pioneered two fully implanted hearing technologies. We are the only company to have gotten a fully implanted active hearing device through the FDA approval process to date. We received Breakthrough Device Designation from the FDA for our fully implanted investigational cochlear implant. We believe we are going to be a leader as the industry moves to fully implanted hearing implants, and we will continue to carefully protect ourselves and make it difficult on others to recreate what we have in our product portfolio."

The patent, titled "Cochlear Implant System with Improved Input Signal-To-Noise Ratio," covers innovations involving an input source with a sensor and a powered signal modifier that includes an amplifier. In this design, the sensor receives an acoustic stimulus and outputs a signal that is immediately amplified to generate a robust analog input signal. Amplifying the signal at the input source helps reduce noise and interference within the system, supporting clearer and more reliable auditory performance.

"It is important to understand that Envoy Medical made certain critical design decisions around its fully implanted cochlear implant many years ago that others did not," said Brent Lucas, Chief Executive Officer of Envoy Medical. "Our sensor technology is fundamentally different from a subdermal microphone. Our replaceable rechargeable battery in the chest is fundamentally different from a non-replaceable rechargeable battery in the head. Our device does not come with an external sound processor or a magnet. We are approaching fully implanted cochlear implants differently than the competition, and we believe that we made the right design choices that will resonate with patients in the future and that the differentiation between our products and others will set us apart from the competition for many years to come."

The Acclaim cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part of a U.S. based pivotal clinical trial. For more information on the trial, visit www.envoymedical.com/acclaim-pivotal.

To be added to the Envoy Medical email distribution list, please email Envoy@kcsa.com with COCH in the subject line.

About Envoy Medical, Inc.
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.

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.

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 operations; the ability to obtain additional patents and develop future products or product improvements; the ability to obtain and maintain compliance with Nasdaq rules and requirements; the timing and future outcome of its FDA pivotal trial; the ability to raise capital and the amount of capital required to complete the FDA pivotal trial; the Acclaim CI being the first to market fully implanted cochlear implant; the timing and results of activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI; and the participation or any changes or delays in participation of any subjects, institutions, or healthcare professionals in such trials; the safety, performance, and market acceptance of the Acclaim CI; the timing and results of the Acclaim CI's PMA submission to the FDA; 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; the ability to engage 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 March 31, 2025, 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.

Investor Contact:
Phil Carlson
KCSA Strategic Communications
O: 212.896.1233
E: Envoy@kcsa.com

Media Contact:
Anne Donohoe
KCSA Strategic Communications
O: 732-620-0033
E: Envoy@kcsa.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/278066

FAQ

What did Envoy Medical (COCH) announce on December 16, 2025?

Envoy announced issuance of Australian Patent No. 2022229818 covering improved input SNR for its cochlear implant.

How does the new COCH patent improve cochlear implant performance?

The patent covers an input sensor with a powered amplifier at the source to create a stronger analog input and reduce noise.

Does Envoy Medical (COCH) have FDA recognition for its cochlear implant?

Yes; the Acclaim cochlear implant previously received FDA Breakthrough Device Designation and is in a U.S. pivotal trial.

When was the Australian patent for COCH granted?

The patent was granted by the Australian Patent Office on October 16, 2025.

How much has Envoy Medical (COCH) invested in its technology so far?

The company stated it has invested roughly $300 million over several decades to develop its fully implanted technologies.