As filed with the U.S. Securities and Exchange Commission on February 9, 2026 Registration No. 333-292260 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 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 (Name, address, including zip code, and telephone number, including area code, of agent for service) With copies to: Approximate date of commencement ...

As filed with the U.S. Securities and Exchange Commission on February 6, 2026 Registration No. 333-292260 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) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Delaware 3842 86-1369123 (IRS Employer Identification Number) 4875 White Bear Parkw ...

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 ...

Financial Performance - For the three months ended June 30, 2025, the company reported a net loss of $5.7 million, compared to a net loss of $3.9 million for the same period in 2024, and for the six months ended June 30, 2025, the net loss was $10.7 million, compared to $10.2 million in 2024[122]. - The company has an accumulated deficit of $297.9 million as of June 30, 2025, up from $284.7 million as of December 31, 2024[122]. - The company expects to continue incurring net losses and increasing expenses related to research and development, sales and marketing, and general administrative costs[122]. - Net loss for the three months ended June 30, 2025, was $5,690 thousand, a 38.6% increase compared to the same period in 2024[147]. - For the six months ended June 30, 2025, net revenues decreased by $3 thousand, or 2.4%, compared to the same period in 2024[158]. - The company incurred a net loss of $10.7 million for the six months ended June 30, 2025, adjusted for non-cash expenses[172]. Revenue and Sales - Revenue is currently derived primarily from the sale of the Esteem FI-AMEI implants, with new implantations expected to be minimal, potentially as low as zero per year[129]. - Upon commercialization of the Acclaim CI, the company expects revenues to exceed those from the Esteem FI-AMEI[130]. - Net revenues increased by $10 thousand for the three months ended June 30, 2025, representing a 14.7% increase compared to the same period in 2024[147]. Research and Development - The Acclaim CI, the company's lead product candidate, is designed to address severe to profound sensorineural hearing loss and received FDA Breakthrough Device Designation in 2019[111]. - The Investigational Device Exemption (IDE) for the Acclaim CI was granted by the FDA in October 2024, allowing for a pivotal clinical study with an initial enrollment of 10 participants[116]. - The company anticipates submitting a Premarket Approval (PMA) application to the FDA after collecting data from all 56 study participants, with a target FDA decision expected in the second half of 2027 or first half of 2028[119]. - R&D product costs decreased by $473 thousand, while personnel costs increased by $254 thousand, indicating a shift from development to clinical trials[150]. - R&D expenses increased by $0.3 million to $5.233 million for the six months ended June 30, 2025, compared to $4.951 million in 2024, with personnel costs rising by 26.7%[160]. Expenses - Sales and marketing expenses decreased by $136 thousand, or 27.4%, to $361 thousand for the three months ended June 30, 2025[147]. - General and administrative expenses increased by $481 thousand, or 30.3%, to $2,068 thousand for the three months ended June 30, 2025, primarily due to a severance accrual[147]. - Sales and marketing expenses decreased by $0.1 million to $0.9 million for the six months ended June 30, 2025, primarily due to a reduction in legal and professional fees[161]. - General and administrative expenses increased by $0.2 million to $2.2 million for the six months ended June 30, 2025, mainly due to a severance accrual for the former CFO[162]. Cash Flow and Financing - Net cash used in operating activities was $8.185 million for the six months ended June 30, 2025, compared to $10.235 million in 2024, reflecting a decrease in net loss[171]. - Net cash provided by financing activities was $7.992 million for the six months ended June 30, 2025, primarily from Term Loans of $10.0 million[177]. - The company had $5.3 million in cash as of June 30, 2025, down from $5.5 million at the end of 2024[168]. - The company expects to have sufficient funds for operations through September 2025, assuming no additional funding[170]. Economic and Market Conditions - Macroeconomic conditions, including global conflicts and inflation, have impacted the company's financial performance and ability to raise capital[125]. - Inflationary factors may adversely affect operating results, although the company does not believe inflation has materially impacted its financial position to date[197]. Accounting and Financial Management - The company has elected not to opt out of the extended transition period under the JOBS Act, allowing it to adopt new accounting standards at the same time as private companies[192]. - The company maintains cash with high credit quality financial institutions and has not experienced losses on such accounts[195]. - The company performs credit evaluations of customers and does not require collateral, with no material losses reported on accounts receivable[196]. - There have been no material losses on accounts receivable, with no customers accounting for 10% or more of sales for the periods ended June 30, 2025, and 2024[196]. - The change in fair value of the forward purchase agreement warrant liability resulted in a gain of $0.5 million for the six months ended June 30, 2025, compared to a loss of $18 thousand in 2024[164]. Clinical Trials and Warranty - The company estimates clinical trial expenses based on patient enrollment and related costs, adjusting accrued liabilities as actual costs become known[188]. - A lifetime warranty was offered to clinical trial patients, with an estimated cost per unit of $6,000 and an average battery life of five years[189]. - Stock-based compensation is measured at grant date using the Black-Scholes option model, with fair value recognized over the requisite service period[190].

Financial Performance - Net revenues increased by $10 thousand for the three months ended June 30, 2025, compared to the same period in 2024[7] - Net revenues for Q2 2025 were $78 million, an increase from $68 million in Q2 2024, while net revenues for the first half of 2025 were $124 million, down from $127 million in the same period of 2024[25] - The operating loss for Q2 2025 was $(5,070) million, compared to $(4,852) million in Q2 2024, indicating a worsening financial performance[25] - The net loss attributable to common stockholders for Q2 2025 was $(6,942) million, compared to $(5,312) million in Q2 2024, reflecting a decline in profitability[25] Expenses - R&D expenses decreased by $0.1 million to $2.485 million for the three months ended June 30, 2025, compared to the same period in 2024[8] - General and administrative expenses increased by $0.5 million for the three months ended June 30, 2025, primarily due to a $0.3 million severance accrual[9] - Total costs and operating expenses for Q2 2025 were $5,148 million, compared to $4,920 million in Q2 2024, with a significant increase in research and development costs to $2,485 million from $2,591 million[25] - Stock-based compensation increased to $306 million in the first half of 2025 from $265 million in the same period of 2024, indicating a focus on employee incentives[27] Cash Flow and Assets - Cash as of June 30, 2025, was approximately $5.3 million[9] - Cash flows from operating activities resulted in a net cash used of $(8,185) million for the first half of 2025, an improvement from $(10,235) million in the same period of 2024[27] - The company reported cash and cash equivalents of $5,287 million at the end of Q2 2025, compared to $1,746 million at the end of Q2 2024[27] - Total current assets decreased from $8.896 million as of December 31, 2024, to $7.513 million as of June 30, 2025[23] Liabilities - Total liabilities increased from $30.380 million as of December 31, 2024, to $39.759 million as of June 30, 2025[23] Research and Development - All 10 study participants in the Acclaim® trial successfully completed their one-month follow-up visits with zero reported serious adverse events[5] - The company anticipates that study participants will complete their three-month follow-up visits in the coming weeks[5] Intellectual Property and Market Adoption - Five Category III CPT codes for fully implantable active middle ear implants were approved and became effective on July 1, 2025, potentially enhancing market adoption[5] - Two new patents in the US and three in Australia were issued to Envoy Medical, strengthening its intellectual property portfolio[5] Financing Activities - The company raised $10 million from the issuance of term loans payable (related party) during the first half of 2025, compared to $7.5 million in the same period of 2024[27] - The company paid $1,820 million in dividends to stockholders of Series A Preferred Stock during the first half of 2025, reflecting ongoing commitments to preferred shareholders[27] - The company experienced a change in fair value of publicly traded warrant liability, resulting in a loss of $(162) million in the first half of 2025, compared to a gain of $376 million in the same period of 2024[27]

Financial Performance - Net revenues for the first quarter of 2025 decreased by $13 thousand to $46 thousand compared to $59 thousand in the same period of 2024, primarily due to a decrease in battery replacement sales caused by supply chain limitations[5] - The operating loss for the first quarter of 2025 was $5.107 million, compared to an operating loss of $4.884 million in the same period of 2024[21] - The net loss attributable to common stockholders for the first quarter of 2025 was $6.236 million, or $0.29 per share, compared to a net loss of $7.635 million, or $0.41 per share, in the same period of 2024[21] - Net loss for the three months ended March 31, 2025, was $4.998 million, an improvement from a net loss of $6.270 million in the same period of 2024[24] Cash Flow and Liquidity - Cash and cash equivalents as of March 31, 2025, were approximately $5.3 million, down from $5.5 million as of December 31, 2024[9] - Net cash used in operating activities decreased to $3.725 million from $5.589 million year-over-year[24] - Cash provided by financing activities was $3.554 million, down from $6.426 million in the previous year[24] - Cash at the end of the period was $5.312 million, compared to $4.945 million at the end of the same period last year[24] Expenses - Research and development expenses increased by $400 thousand to $2.748 million for the first quarter of 2025, compared to $2.360 million in the same period of 2024, driven by increased headcount and contractor costs[7] - General and administrative expenses decreased by $284 thousand to $1.821 million for the first quarter of 2025, compared to $2.105 million in the same period of 2024, mainly due to reduced legal fees[9] - Depreciation increased to $61,000 from $34,000 year-over-year[24] - Stock-based compensation rose to $160,000 from $123,000 in the prior year[24] Liabilities - Total liabilities increased to $34.609 million as of March 31, 2025, compared to $30.380 million as of December 31, 2024[20] - Accrued and unpaid dividends on Series A Preferred Stock amounted to $25,000, a significant decrease from $1.365 million in the same period last year[24] Clinical Trial Progress - The company secured an additional $10 million in funding to advance its pivotal clinical trial for the fully implanted Acclaim cochlear implant[6] - The company completed enrollment of 10 participants in the first stage of the pivotal clinical trial, with six participants activated and two completing one-month follow-up visits[6] - The company reported no serious adverse events or unanticipated adverse device effects during the clinical trial activations[6] Other Financial Metrics - The company recorded a change in fair value of publicly traded warrant liability of $(194,000), compared to $1.177 million in the previous year[24] - Payments on insurance financing loans were $233,000, slightly down from $257,000 year-over-year[24] - The company issued warrants with term loans (related party) valued at $688,000, with no similar issuance in the previous year[24]