Envoy Medical Reports Third Quarter 2026 Results and Highlights Continued Progress

Company Reaches Six-Month Milestone in Pivotal Trial of Fully Implanted Cochlear Implant

Second Module of Modular PMA Application Submitted to FDA Following Quarter End

White Bear Lake, Minnesota--(Newsfile Corp. - November 5, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health and neuroprosthetics company pioneering fully implanted hearing solutions, today reported financial results for the third quarter ended September 30, 2026, and provided a business update, highlighting continued execution on its corporate initiatives.

"We continued to make significant progress with our investigational fully implanted cochlear implant during the third quarter, as we approach an extremely exciting 2027," said Brent Lucas, Chief Executive Officer of Envoy Medical. "Not only did we report encouraging 12-month data from the first 10 participants in our trial, but we also surpassed the three-month follow-up mark for the full cohort. Since quarter end, we have now surpassed the six-month follow-up milestone. We remain on track for all participants to complete their 12-month visits by early in the second quarter of 2027. Each milestone brings us closer to offering cochlear implant candidates a fully implanted option they have wanted for decades."

Corporate and Financial Highlights for Q3 2026:

• Positive 12-Month Data Showed Continued Improvement in Speech Perception. The Company reported positive 12-month data from the first 10 participants in Stage 1 of its pivotal clinical trial of the investigational fully implanted Acclaim® cochlear implant. These participants achieved a mean Consonant-Nucleus-Consonant ("CNC") word recognition score of 53.2% at their 12-month visits, compared to a pre-implantation baseline of 15.2%, a 38.0 percentage point improvement and continued gains from the 24.0 percentage point improvement reported at six months. The trial's primary efficacy endpoint will be evaluated based on 12-month data.
  
  
• Three-Month Follow-Up Window Completed for Full Cohort. The Company announced that its pivotal clinical trial evaluating the investigational fully implanted Acclaim® cochlear implant passed the three-month follow-up window, marking another key clinical milestone as the Company advances the study toward its primary efficacy endpoint, which will be evaluated on 12-month data.
  
  
• Expanded Global Intellectual Property Portfolio. The Company was granted Canadian and Hong Kong patents relating to implantable cochlear system design and middle ear sensor signal processing, expanding its global portfolio to 97 granted patents, consisting of 40 U.S. and 57 foreign patents, with an additional 35 applications pending.

Highlights Subsequent to Q3 2026:

• Second Module of Modular PMA Application Submitted to the FDA. The Company submitted the second module of its Modular Premarket Approval ("PMA") application to the U.S. Food and Drug Administration ("FDA") for its Breakthrough Device-designated investigational Acclaim® cochlear implant. The Company expects to submit a total of four modules, with the final module containing final clinical trial data. The Company expects all Stage 2 participants to complete 12-month data collection by early in the second quarter of 2027, with submission of the final module planned to follow a few months thereafter.
  
  
• Six-Month Follow-Up Visit Milestone Surpassed. The Company announced that its pivotal clinical trial evaluating the investigational fully implanted Acclaim® cochlear implant surpassed the six-month follow-up visit milestone for all 56 patients. To the Company's knowledge, Envoy Medical is the first company to reach this milestone in a U.S. pivotal clinical trial of a fully implanted cochlear implant. The trial's primary efficacy endpoint will be evaluated based on 12-month data.
  
  
• Atlas Litigation Dismissed. On October 6, 2026, the Company entered into a dismissal agreement with Atlas Merchant Capital SPAC Fund I LP, under which all claims asserted by Atlas in the litigation filed in the Delaware Court of Chancery were dismissed with prejudice, and the litigation was terminated without any payment by the Company or the other defendants.

Financial Results for the Quarter Ended September 30, 2026 (dollars in thousands):

Net revenue was $66 for the three months ended September 30, 2026, compared to $42 for the three months ended September 30, 2025.

Cost of goods sold for the three months ended September 30, 2026, was $244, compared to $203 for the three months ended September 30, 2025.

R&D expenses for the three months ended September 30, 2026, were $3,077 compared to $2,700 for the three months ended September 30, 2025. This increase of $377 mainly reflects additional clinical trial follow-up activity following completion of enrollment in the first quarter of 2026 and higher costs related to supporting the clinical trial and ongoing regulatory submissions, partially offset by lower product costs.

Sales and marketing expenses for the three months ended September 30, 2026, were $157 compared to $405 for the three months ended September 30, 2025. The decrease of $248 is primarily due to the reallocation of field clinical specialists to research and development activities in support of the clinical trial.

General and administrative expenses were $2,125 for the three months ended September 30, 2026, compared to $1,999 for the three months ended September 30, 2025. The increase of $126 was primarily due to modest increases in compensation, stock-based compensation, and professional services expenses.

Net loss attributable to common stockholders was $5,240, or $0.50 per basic and diluted share for the three months ended September 30, 2026, compared to net loss attributable to common stockholders of $7,747, or $3.55 per basic and diluted share for the three months ended September 30, 2025.

As of September 30, 2026, cash was approximately $14,570.

Conference Call Information:

Envoy Medical management will host a conference call today at 8:00 A.M. ET to discuss these results and provide a business update.

Third Quarter 2026 Financial Results Conference Call:
Date: Thursday, November 5, 2026
Time: 8:00 A.M. ET
Live Call: 1-800-267-6316 (U.S. Toll Free) or 1-203-518-9783 (International)
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1778210&tp_key=20071611a1

For interested individuals unable to join the conference call, a replay will be available through November 19, 2026, by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671 (International). Participants must use the following code to access the replay of the call: 11162715.

For more information about Envoy Medical's innovation pipeline and intellectual property portfolio, visit EnvoyMedical.com.

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 and neuroprosthetics 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.

Click here for important information.