Envoy Medical Submits First Module of Modular Premarket Approval Application to the U.S. Food and Drug Administration for Breakthrough-Designated Device

Modular Regulatory Strategy Creates Defined Milestone Cadence, Enables Earlier FDA Engagement, and Supports Targeted Final Clinical Module Submission Planned for Q2 2027

White Bear Lake, Minnesota--(Newsfile Corp. - June 30, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced the submission of the first module of its Modular Premarket Approval ("PMA") application to the U.S. Food and Drug Administration ("FDA") for its FDA Breakthrough Device-designated product.

The submission marks the first regulatory milestone in the Company's planned modular PMA strategy. Unlike a traditional PMA, which is submitted as a single comprehensive application, the modular PMA pathway allows the Company to submit completed sections to the FDA for review as they become available, rather than waiting to compile and submit the entire submission at once. Envoy Medical expects to submit a total of four modules, with the final module containing final clinical trial data targeted for submission in the second quarter of 2027.

By utilizing the modular PMA pathway, the Company expects to engage with the FDA throughout the review process, allowing for earlier regulatory feedback while establishing a series of defined development milestones. Management believes this approach provides investors with greater visibility into the Company's progress and may reduce execution risk by identifying potential issues earlier in the review process.

"We believe the modular PMA approach is the right strategy for advancing our breakthrough-designated device through the FDA review process," said Brent Lucas, Chief Executive Officer of Envoy Medical." This submission represents the first of several milestones that we expect to achieve over the coming quarters. Rather than concentrating regulatory risk into a single binary event at the end of a multi-year process, this approach gives us a roadmap with meaningful accomplishments along the way. Each submitted module enables ongoing engagement with the FDA and creates a clearer framework for measuring our execution. We remain focused on advancing what we believe is a differentiated hearing solution for a large population of people interested in Invisible Hearing® technology."

Key advantages of the modular PMA approach for Envoy Medical include:

• Earlier FDA Engagement: The FDA can begin reviewing submitted modules, such as nonclinical data and manufacturing information, while the clinical trial is ongoing, allowing the review process to progress in parallel with remaining data collection.
• Iterative Feedback and Risk Reduction: Receiving FDA input on individual modules allows the Company to address any questions or concerns proactively, reducing the chance of unanticipated issues or delays upon final submission. The Company believes this proactive approach reflects prudent use of capital and helps to reduce the risk profile of the overall regulatory process.
• A Structured Investor Roadmap: With four planned modules, Envoy Medical expects to have multiple opportunities to report meaningful progress to investors over the next year, providing investor visibility into the Company's advancement toward a potential approval decision.
• Aligned with Breakthrough Device Designation: As an FDA-designated Breakthrough Device, Envoy Medical's product is eligible for more intensive FDA interaction and guidance throughout the review process. The modular PMA structure, which requires FDA agreement and alignment on the submission framework in advance, is a natural fit for this level of ongoing collaboration with the FDA.

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.

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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.

 See Important Information here.