Form 8-K

8-K — Envoy Medical, Inc.

Accession: 0001213900-26-054185

Filed: 2026-05-11

Period: 2026-05-11

CIK: 0001840877

SIC: 3842 (ORTHOPEDIC, PROSTHETIC & SURGICAL APPLIANCES & SUPPLIES)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities

Exchange Act of 1934

Date of Report (Date of earliest event reported):

May 11, 2026

ENVOY MEDICAL, INC.

(Exact name of registrant as specified in its

charter)

Delaware

001-40133

86-1369123

(State or other jurisdiction

of incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

4875 White Bear Parkway

White Bear Lake, MN

55110

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including

area code: (877) 900-3277

Not Applicable

(Former name or former address, if changed since

last report)

Check the appropriate box below if the Form 8-K filing is intended

to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which

registered

Class A Common Stock, par value $0.0001 per share

COCH

The Nasdaq Stock Market LLC

Redeemable Warrants, each whole Warrant exercisable for one share of Class A Common Stock at an exercise price of $11.50 per share

COCHW

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth

company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange

Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant

has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant

to Section 13(a) of the Exchange Act. ☐

Item 2.02. Results of Operations and Financial Condition.

On May 11, 2026, Envoy Medical, Inc. (the

“Company”), issued a press release regarding the Company’s financial results for its fiscal quarter ended March 31,

2026. A copy of the Company’s press release is attached hereto as Exhibit 99.1.

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 March 11, 2026

104

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

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.

May 11, 2026

By:

/s/ Brent Lucas

Brent Lucas

Chief Executive Officer

EX-99.1 — PRESS RELEASE DATED MARCH 11, 2026

EX-99.1

Filename: ea028996501ex99-1.htm · Sequence: 2

Exhibit 99.1

Envoy Medical Reports Landmark Accomplishments,

Advancing Toward

FDA Approval of First-Of-Its-Kind Fully Implanted Cochlear Implant

Company Completes Historic Trial Enrollment,

Secures Transformational Financing, and

Sees Promising Early Clinical Data Presented at Industry Conferences

White Bear Lake, Minnesota – May 11,

2026 – Envoy Medical® Inc. (NASDAQ: COCH) (“Envoy Medical” or the “Company”), a hearing

health company pioneering fully implanted hearing solutions, today reported first quarter 2026 results and landmark achievements that

advance the Company another step closer toward commercialization of its investigational Acclaim® cochlear implant.

“The

first quarter of 2026 marked a transformative period for Envoy Medical, highlighted by the completion of enrollment in our pivotal clinical

trial and the successful execution of a significant financing,” said Brent Lucas, Chief Executive Officer of Envoy Medical.

“Achieving full enrollment in our pivotal clinical

study represents a critical step. We continue to be encouraged by the trial’s progress and remain focused on advancing toward PMA

submission and, ultimately, commercialization. With a substantially strengthened balance sheet and the support of leading healthcare investors,

we believe we are well positioned to execute on our strategic objectives and deliver on the roadmap ahead.”

Corporate and Financial Highlights for Q1 2026:

● Pivotal

Trial Enrollment Complete — A First for the Industry

In a defining milestone for the hearing health sector, Envoy

Medical became the first cochlear implant company to achieve full enrollment of a U.S. pivotal clinical trial evaluating a fully implanted

cochlear implant seeking FDA approval. The 56th and final patient was successfully implanted on March 11, 2026, completing enrollment

across U.S. sites. The Company is now collecting 12-month follow-up data from all participants, with a Premarket Approval (PMA) submission

to the FDA to follow.

● Transformational

Capital Raise

Envoy Medical closed an upsized public offering for up to

$78.0 million, including $30.0 million in gross proceeds at closing with up to an additional $48.0 million of potential aggregate gross

proceeds upon the exercise in full of milestone-linked warrants. The financing was led by Nantahala Capital and included healthcare-dedicated

funds such as Broadfin Holdings, as well as existing shareholders including members of the Board and management team.

● Expanded

Intellectual Property Portfolio

As of February 20, 2026, Envoy Medical has expanded its global

IP portfolio to 47 patents across North America, Europe, Asia, and Australia. In February alone, the Company secured three new patents

strengthening its competitive position in the fully implanted hearing space.

Highlights Subsequent to Q1 2026:

● Promising

Early Clinical Data Presented

Interim six-month clinical data from the first 10 patients

in the pivotal study showed no study-defined serious adverse events, mean CNC word recognition improved from 15.2% to 39.2%, median daily

device wear time of 24 hours, and improvements in quality-of-life and tinnitus scores. Initial safety and performance data for these 10

patients were presented at the American Academy of Audiology Annual Conference and the Combined Otolaryngology Spring Meetings.

● All

56 Pivotal Trial Patients Activated

Following the completion of enrollment, Envoy Medical confirmed

that all 56 patients implanted in the pivotal clinical trial have been activated. This milestone validates that the full patient cohort

is progressing through the study protocol on schedule, keeping the Company on track to collect the 12-month endpoint data required for

its planned PMA submission to the FDA.

● Board

Strengthened

Envoy Medical appointed medical device veteran Chas McKhann

to its Board of Directors in April 2026, further enhancing the Company’s expertise as it prepares to conclude its pivotal clinical

study and prepare for commercial launch.

● First

Patients Reach 12-Month Endpoint

The first three patients implanted in the pivotal trial successfully

completed their 12-month endpoint visit, marking a key milestone in the study’s progress. The primary endpoints for the trial are tied

to 12-month data, and achieving this critical milestone on schedule underscores the Company’s continued execution as it steadily marches

toward PMA submission and commercialization.

Financial Results for the Quarter Ended March 31, 2026 (dollars

in thousands):

Net Revenue was $39 for the three months ended March 31, 2026.

Cost of goods sold for the three months ended March 31, 2026, were

$313, compared to $226. The $87 increase is primarily due to higher scrap and materials usage as well as increased fees for third-parties

performing work related to our products.

R&D expenses for the three months ended March 31, 2026, were $3,642

compared to $2,748 for the three months ended March 31, 2025. This increase of $894 mainly reflects additional clinical trial activity

and related personnel costs during enrollment.

Sales and marketing expenses for the three months ended March 31, 2026,

were $164 compared to $358 for the three months ended March 31, 2025. The decrease of $194 is primarily due to the reallocation of resources

to research and development activities in support of the clinical trial.

General and administrative expenses are $1,879 for the three months

ended March 31, 2026, compared to $1,821 for the three months ended March 31, 2025. The increase of $58 was primarily due to higher investor

relations and legal expenses.

As of March 31, 2026, cash was approximately $25,251.

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.

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 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.

Forward-Looking Statements

This press release includes “forward-looking

statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform

Act of 1995. Forward-Looking statements may be identified by the use of words such as “estimate,” “plan,” “project,”

“forecast,” “intend,” “will,” “expect,” “anticipate,” “believe,” “seek,”

“target” or other similar expressions that predict or indicate future events or trends or that are not statements of historical

matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not

limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals

for future operations; the ability to obtain additional patents and develop future products or product improvements; the ability to maintain

compliance with Nasdaq rules and requirements; the timing and future outcome of its FDA pivotal trial; the ability to raise capital and

the amount of capital required to complete the FDA pivotal trial and early commercialization; the Acclaim CI being the first to market

fully implanted cochlear implant; the timing and results of activations, enrollments, follow-up visits, data, and clinical trials of

the Acclaim CI; and the participation or any changes or delays in participation of any subjects, institutions, or healthcare professionals

in such trials; the safety, performance, and market acceptance of the Acclaim CI; the timing and results of the Acclaim CI’s PMA submission

to the FDA; the size of Envoy Medical’s addressable market, operational performance, future market conditions or economic performance

and developments in the capital and credit markets; and any information concerning possible or assumed future operations of Envoy Medical.

The forward-looking statements contained in this press release reflect Envoy Medical’s current views about future events and are subject

to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ

significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the events described will

happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties,

including, but not limited to changes in the market price of shares of Envoy Medical’s Class A Common Stock; changes in or removal of

Envoy Medical’s shares inclusion in any index; Envoy Medical’s success in retaining or recruiting, or changes required in, its officers,

key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the

clinical development process of Envoy Medical products; the ability to engage competition in the medical device industry, and the failure

to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions

in relationships with Envoy Medical’s suppliers, or disruptions in Envoy Medical’s own production capabilities for some of the key components

and materials of its products; changes in the need for capital and the availability of financing and capital to fund these needs; changes

in interest rates or rates of inflation; legal, regulatory and other proceedings could be costly and time-consuming to defend; changes

in applicable laws or regulations, or the application thereof on Envoy Medical; a loss of any of Envoy Medical’s key intellectual property

rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and

other international conflicts; and other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary

Note Regarding Forward-Looking Statements” in the Annual Report on Form 10-K filed by Envoy Medical on March 23, 2026, and in other

reports Envoy Medical files, with the SEC. If any of these risks materialize or Envoy Medical’s assumptions prove incorrect, actual results

could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy

Medical’s good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update

or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future

events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance

on any forward-looking statements, which are based only on information currently available to Envoy Medical.

Investor Contact:

Phil Carlson

KCSA Strategic Communications

O: 212.896.1233

E: Envoy@kcsa.com

Media Contact:

Anne Donohoe

KCSA Strategic Communications

O: 732-620-0033

E: Envoy@kcsa.com

ENVOY MEDICAL, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(UNAUDITED)

(In thousands, except share and per share amounts)

March 31,

December 31,

2026

2025

Current assets:

Cash

$ 25,251

$ 3,739

Accounts receivable, net

Other receivable

Inventories

1,490

1,546

Prepaid expenses and other current assets

893

941

Total current assets

27,682

6,279

Property and equipment, net

962

1,035

Operating lease right-of-use asset (related party)

853

886

Prepaid expenses and other assets

325

358

Total assets

$ 29,822

$ 8,558

Liabilities, mezzanine equity, and stockholders’ equity (deficit)

Current liabilities:

Accounts payable

$ 1,700

$ 2,920

Accrued expenses

9,653

7,639

Forward purchase agreement warrant liability

Product warranty liability, current portion

264

287

Operating lease liability, current portion (related party)

178

174

Other current liabilities

379

518

Total current liabilities

12,211

11,562

Product warranty liability, net of current portion

1,550

1,605

Operating lease liability, net of current portion (related party)

711

745

Private warrant liability

3,830

5,835

Publicly traded warrant liability

941

551

Other liability

Total liabilities

19,270

20,325

Commitments and contingencies (see Note 13)

Mezzanine equity

Warrants issued to placement agent as part of the 2025 Offerings (see Note 9)

391

Stockholders’ equity (deficit)

Series A Preferred Stock, $0.0001 par value; 100,000,000 shares authorized and 10,000,000 shares designated as of March 31, 2026 and December 31, 2025; 4,126,667 shares issued and outstanding as of March 31, 2026 and December 31, 2025

Class A Common Stock, $0.0001 par value; 400,000,000 shares authorized as of March 31, 2026 and December 31, 2025; 76,881,110 shares issued and outstanding as of March 31, 2026 and 28,934,960 shares issued and outstanding as of December 31, 2025

Additional paid-in capital

329,371

301,355

Accumulated deficit

(319,097 )

(313,396 )

Accumulated other comprehensive loss

(121 )

(120 )

Total stockholders’ equity (deficit)

10,161

(12,158 )

Total liabilities, mezzanine equity, and stockholders’ equity (deficit)

$ 29,822

$ 8,558

ENVOY MEDICAL, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE

LOSS

(UNAUDITED)

(In thousands, except share and per share amounts)

Three Months Ended

March 31,

2026

2025

Net revenues

$ 39

$ 46

Costs and operating expenses:

Cost of goods sold

313

226

Research and development

3,642

2,748

Sales and marketing

164

358

General and administrative

1,879

1,821

Total costs and operating expenses

5,998

5,153

Operating loss

(5,959 )

(5,107 )

Other income (expense):

Change in fair value of forward purchase agreement warrant liability

(13 )

421

Loss on offering and change in fair value of private warrant liability

2,005

Change in fair value of publicly traded warrant liability

(390 )

194

Interest expense (related party)

(495 )

Other income (expense), net

(11 )

Total other income (expense), net

1,608

109

Net loss

(4,351 )

(4,998 )

Cumulative preferred dividends

(1,350 )

(1,238 )

Net loss attributable to common stockholders, basic and diluted

$ (5,701 )

$ (6,236 )

Net loss per share attributable to common stockholders, basic and diluted

$ (0.08 )

$ (0.29 )

Weighted-average Class A Common Stock and pre-funded warrants outstanding, basic and diluted

68,934,960

21,326,609

Other comprehensive (loss) income:

Foreign currency translation adjustment

(1 )

Other comprehensive (loss) income

(1 )

Comprehensive loss

$ (4,352 )

$ (4,992 )

ENVOY MEDICAL, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

(Dollars in thousands)

Three Months Ended

March 31,

2026

2025

Cash flows from operating activities

Net loss

$ (4,351 )

$ (4,998 )

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation

Interest expense and amortization of debt discount on Term Loans (related party)

495

Stock-based compensation for services

Amortization of prepaid insurance

227

247

Stock-based compensation

239

160

Loss on offering and change in fair value of private warrant liability

(2,005 )

Change in fair value of publicly traded warrant liability

390

(194 )

Change in fair value of forward purchase agreement warrant liability

(421 )

Net change in operating lease (related party)

Change in inventory reserve

(23 )

Changes in operating assets and liabilities:

Accounts receivable, net

(4 )

Other receivable

757

Inventories

Prepaid expenses and other current assets

(121 )

(75 )

Accounts payable

(1,220 )

Operating lease liability (related party)

(52 )

(22 )

Accrued expenses

664

199

Product warranty liability

(78 )

(17 )

Net cash used in operating activities

(6,061 )

(3,725 )

Cash flows from investing activities

Purchases of property and equipment

(6 )

Net cash used in investing activities

(6 )

Cash flows from financing activities

Payments on insurance financing loans

(208 )

(233 )

Proceeds from the issuance of Term Loans (related party)

5,000

Dividends paid to stockholders of Series A Preferred Stock

(1,213 )

Proceeds from the issuance of Class A Common Stock, Issued Pre-Funded Warrants, and Series A Warrants

29,997

Offering costs from the issuance of Class A Common Stock, Issued Pre-Funded Warrants, and Series A Warrants

(2,215 )

Net cash provided by financing activities

27,574

3,554

Effect of exchange rate changes on cash

(1 )

Net (decrease) increase in cash

21,512

(171 )

Cash, beginning of period

3,739

5,483

Cash, end of period

$ 25,251

$ 5,312

Supplemental disclosures of cash flow information:

Cash paid for interest

$ 11

$ 13

Non-cash investing and financing activities:

Accrued and unpaid dividends on Series A Preferred Stock

$ 1,350

$ 25

Financing of prepaid insurance

$ 69

$ 75

Issuance of Term Loan Warrants (related party)

$ -

$ 688

Issuance of Placement Agent Warrants

$ 678

$ -

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Two-character EDGAR code representing the state or country of incorporation.

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No definition available.

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- Definition

The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

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- Definition

The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

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Local phone number for entity.

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No definition available.

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

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- Definition

Title of a 12(b) registered security.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

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Name of the Exchange on which a security is registered.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

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Trading symbol of an instrument as listed on an exchange.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

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