As filed with the U.S. Securities and Exchange Commission on December 18, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Envoy Medical, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 3842 86-1369123 (IRS Employer Identification Number) 4875 White Bear ...

As filed with the U.S. Securities and Exchange Commission on December 1, 2025. Registration No. 333-290927 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Envoy Medical, Inc. (Exact name of registrant as specified in its charter) Delaware 3842 86-1369123 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (IRS Employer Identification ...

Financial Performance - For the three months ended September 30, 2025, the company reported a net loss of $6,482, compared to a net loss of $5,960 for the same period in 2024, and for the nine months ended September 30, 2025, the net loss was $17,170, compared to $16,177 in 2024[144]. - The company has an accumulated deficit of $305,659 as of September 30, 2025, up from $284,734 as of December 31, 2024[144]. - Net revenues for the three months ended September 30, 2025, were $42,000, a decrease of $14,000 or 25.0% compared to the same period in 2024[186]. - Net revenues decreased by $17, or 9.3%, for the nine months ended September 30, 2025, compared to the same period in 2024[198]. - Total costs and operating expenses increased by $1,161, or 7.8%, leading to an operating loss of $15,885 for the nine months ended September 30, 2025[197]. - The operating loss for the three months ended September 30, 2025, was $5,708,000, an increase of $736,000 or 14.8% compared to the same period in 2024[186]. - Cash used in operating activities was $12,516 for the nine months ended September 30, 2025, primarily funding a net loss of $17,170[213]. - As of September 30, 2025, the company had $3,556 in cash, down from $5,483 at the end of 2024[209]. Research and Development - The FDA granted the Investigational Device Exemption (IDE) for the Acclaim CI in October 2024, allowing the company to begin a pivotal clinical study[140]. - The first stage of the clinical trial for the Acclaim CI involved 10 participants, with no serious adverse events reported, leading to FDA approval for the second stage on October 3, 2025[147]. - The second stage of the clinical trial will enroll an additional 46 participants, with the first three patients already enrolled as of October 31, 2025[148]. - The company anticipates submitting a Premarket Approval (PMA) application to the FDA after completing the clinical trial, with a potential decision expected in the second half of 2027[142]. - The company expects R&D expenses to continue increasing as it initiates clinical trials for the Acclaim CI product[175]. - R&D expenses for the nine months increased by $225 to $7,933, with personnel costs up 5.2% and other R&D costs up 107.2%[200]. Expenses and Costs - Cost of goods sold increased by $16,000 to $203,000 for the three months ended September 30, 2025, primarily due to increased material waste during production[188]. - Research and development expenses for the three months ended September 30, 2025, were $2,700,000, a slight decrease of $57,000 or 2.1% compared to 2024[186]. - General and administrative expenses rose by $752,000 or 44.5% to $2,442,000 for the three months ended September 30, 2025[186]. - Sales and marketing expenses increased by $11, primarily due to increased headcount-related expenses, despite a reduction in legal fees of $112[190]. - General and administrative expenses rose by $752, driven by public company costs and expenses related to the September 2025 Offering[191]. - Interest expense related to party loans increased by $1,158, or 268.1%, due to additional issuances of Term Loans[207]. Financing Activities - The company entered into a Securities Purchase Agreement on September 22, 2025, to issue 1,908,402 shares of Common Stock at a price of $1.31 per share[154]. - The September 2025 Offering closed on September 23, 2025, resulting in aggregate gross proceeds of $2,500,000, with potential additional proceeds of $7,500,000 if warrants are fully exercised[156]. - The October 2025 Offering closed on October 9, 2025, generating aggregate gross proceeds of $4,000,000, with potential additional proceeds of $12,000,000 from warrant exercises[160]. - Net cash provided by financing activities for the nine months ended September 30, 2025 was $10,593, driven by proceeds from the issuance of Term Loans of $10,000 and a September 2025 Offering of $2,500[217]. - Net cash provided by financing activities for the nine months ended September 30, 2024 was $14,581, primarily from $15,000 proceeds from the 2024 Term Loans[218]. Compliance and Regulatory Issues - The company received a deficiency notification from Nasdaq regarding non-compliance with the market value listing requirement, with a grace period until February 23, 2026, to regain compliance[149][152]. - The company is targeting FDA approval for the Acclaim CI in the second half of 2027 or first half of 2028[166]. Market Conditions - Macroeconomic conditions, including global conflicts and inflation, have impacted the company's financial performance and capital raising ability[162]. - Inflationary factors may adversely affect operating results, with potential impacts on gross margin if selling prices do not increase accordingly[237]. Other Financial Information - The gain from the change in the fair value of the forward purchase agreement warrant liability was $64, a significant improvement from a loss of $311 in the prior year[192]. - The fair value of the forward purchase agreement warrant liability was estimated at $12 as of September 30, 2025, reflecting a change in fair value of $(522)[224]. - The company has not experienced any material differences between accrued costs and actual costs incurred since inception[227]. - The company has not experienced any losses on accounts receivable and does not believe it is exposed to unusual credit risk[235]. - There were no customers accounting for 10% or more of sales for the three and nine months ended September 30, 2025 and 2024[236].

Financial Performance - Third quarter net revenue was $42,000 for the three months ended September 30, 2025 [10]. - Net revenues for the three months ended September 30, 2025, were $42,000, a decrease of 25% compared to $56,000 for the same period in 2024 [20]. - The operating loss for the three months ended September 30, 2025, was $(5,708,000), compared to $(4,972,000) for the same period in 2024, reflecting a 14.8% increase in losses [20]. - Net loss attributable to common stockholders for the nine months ended September 30, 2025, was $(20,925,000), compared to $(20,287,000) in 2024, indicating a 3.2% increase in losses [20]. - Total costs and operating expenses for the nine months ended September 30, 2025, increased to $16,051,000, up 7.8% from $14,890,000 in 2024 [20]. Cash Flow and Liquidity - Cash as of September 30, 2025, was approximately $3.56 million, with additional capital raised post quarter end [10]. - Cash, at the end of the period on September 30, 2025, was $3,556,000, down from $4,424,000 at the end of the same period in 2024 [21]. - Cash flows from operating activities for the nine months ended September 30, 2025, resulted in a net cash used of $(12,516,000), slightly improved from $(12,858,000) in 2024 [21]. - The company reported a net cash provided by financing activities of $10,593,000 for the nine months ended September 30, 2025, compared to $14,581,000 in 2024, reflecting a decrease of 27.5% [21]. Research and Development - R&D expenses decreased by $57,000 to $2.7 million compared to the same period in 2024, as the company transitioned from development to clinical trial phase [10]. - Research and development expenses for the nine months ended September 30, 2025, were $7,933,000, an increase of 2.9% from $7,708,000 in 2024 [20]. Debt and Liabilities - Envoy Medical extinguished over $32 million in debt, significantly improving its balance sheet and stockholder's equity [4]. - Total liabilities decreased from $30.38 million in December 2024 to $15.71 million as of September 30, 2025 [19]. - The company incurred interest expense of $1,590,000 related to party loans for the nine months ended September 30, 2025, compared to $432,000 in 2024, showing a significant increase of 268.5% [21]. Clinical Trials and Approvals - The company received FDA approval to expand its pivotal clinical trial to the final stage based on promising three-month data [5]. - The first three patients were enrolled in the final stage of the pivotal clinical trial for the fully implanted investigational Acclaim cochlear implant [5]. - The company marked the three-year anniversary of the first successful implantation of its fully implanted cochlear implant [5]. Patent and Intellectual Property - Envoy Medical secured four new global patents and expanded its patent portfolio with additional patents in the U.S., Europe, and Australia [5]. General and Administrative Expenses - General and administrative expenses increased by $752,000 primarily due to public company costs and expenses related to a September 2025 offering [10]. Stock Information - The weighted-average Class A Common Stock outstanding for the nine months ended September 30, 2025, was 21,522,618, compared to 18,605,482 in 2024, indicating an increase of 15.5% [20].

As filed with the U.S. Securities and Exchange Commission on October 17, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Envoy Medical, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 3842 86-1369123 (Primary Standard Industrial Classification Code Number) (IRS Employer Identification Number) 4875 White Bear P ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ Commission File Number 001-40133 ENVOY MEDICAL, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of in ...

Exhibit 99.1 Envoy Medical Reports on Second Quarter 2025 Results White Bear Lake, Minnesota – (July 31, 2025) – Envoy Medical, Inc. (NASDAQ: COCH) ("Envoy Medical"), a revolutionary hearing health company focused on fully implanted hearing devices, today announced its corporate and financial results for the second quarter ended June 30, 2025, as well as other subsequent events. Financial and Corporate Highlights for Second Quarter and to date: Brent Lucas, CEO of Envoy Medical commented: "This quarter was ...

Envoy Medical Reports on First Quarter 2025 Results Exhibit 99.1 Company Provides Update on its Pivotal Clinical Study for Fully Implanted Cochlear Implant WHITE BEAR LAKE, Minnesota--(Newsfile Corp. – May 1, 2025) – Envoy Medical, Inc. (Nasdaq: COCH) ("Envoy Medical"), a revolutionary hearing health company focused on fully implanted hearing devices, today announced its corporate and financial results for the first quarter ended March 31, 2025, as well as other subsequent events. Financial and Corporate Hi ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ Commission File Number 001-40133 ENVOY MEDICAL, INC. (Exact name of registrant as specified in its charter) Delaware 86-1369123 (State or oth ...

Envoy Medical Reports Fourth Quarter and Full Year 2024 Financial Results Company Provides Corporate Update that Includes Information on its Progress Enrolling Subjects in its Pivotal Clinical Study for Breakthrough Device, the Fully Implanted Acclaim® Cochlear Implant WHITE BEAR LAKE, Minn., March 31, 2025 (Newsfile Corp.) -- Envoy Medical®, Inc. ("Envoy Medical") (Nasdaq: COCH), a revolutionary hearing health company focused on fully implanted hearing devices, today announced its corporate and financial r ...