Envoy Medical reported Q3 2026 results

Item 2.02. Results of Operations and Financial

Condition.

On November 5, 2026, Envoy Medical, Inc.

(the "Company"), issued a press release regarding the Company's financial results for its fiscal quarter ended September 30, 2026. A copy of the Company's press release is attached hereto as Exhibit 99.1¹.

The information in this Item 2.02, including the accompanying exhibit, is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange

Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section. The information in this Item 2.02 shall not be incorporated into any filing pursuant to the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit

Number

Description

99.1

Press Release dated November 5, 2026.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

1

SIGNATURES

Pursuant to the requirements of the Securities

Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

ENVOY MEDICAL, INC.

November 5, 2026

By:

/s/ Robert Potashnick

Robert Potashnick

Interim Chief Financial Officer

2

PRESS RELEASE DATED NOVEMBER 5, 2026

Exhibit 99.1

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-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 data².

● 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 data³. 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 patients⁴. 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 mont