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Form 8-K

sec.gov

8-K — Envoy Medical, Inc.

Accession: 0001213900-26-087221

Filed: 2026-08-10

Period: 2026-08-10

CIK: 0001840877

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

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — ea0301372-8k_envoy.htm (Primary)

EX-99.1 — PRESS RELEASE DATED AUGUST 10, 2026 (ea030137201ex99-1.htm)

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2026-08-10

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COCH:RedeemableWarrantsEachWholeWarrantMember

2026-08-10

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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):

August 10, 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 August 10, 2026, Envoy Medical, Inc. (the

“Company”), issued a press release regarding the Company’s financial results for its fiscal quarter ended June 30,

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 August 10, 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.

August 10, 2026

By:

/s/ Robert Potashnick

Robert Potashnick

Interim Chief Financial Officer

2

EX-99.1 — PRESS RELEASE DATED AUGUST 10, 2026

EX-99.1

Filename: ea030137201ex99-1.htm · Sequence: 2

Exhibit 99.1

Envoy Medical Reports Second Quarter 2026 Results

and Achieves Key Regulatory and Clinical Milestones

Submitted First Module of Modular PMA Application

to FDA

Subsequent to Quarter End, the Company Reported

Positive 12-Month Stage 1 Data Showing Continued Improvement in Speech Perception

White Bear Lake, Minnesota--(Newsfile Corp. – August 10, 2026)

- Envoy Medical® Inc. (NASDAQ: COCH) (“Envoy Medical” or the “Company”), a hearing health company pioneering

fully implanted hearing solutions, today reported financial results for the second quarter ended June 30, 2026, and provided a business

update, highlighting continued execution on its corporate initiatives.

“The second quarter moved us measurably closer to bringing our

fully implanted cochlear implant to market,” said Brent Lucas, Chief Executive Officer of Envoy Medical. “We submitted the

first of four modules of our modular PMA application and our pivotal clinical trial continued to advance. We expect to submit the remaining

modules on a rolling basis, with the fourth and final module targeted during the second quarter of 2027. Since quarter end, we reported

12-month data on the first 10 participants in Stage 1 and the full trial surpassed the three-month follow-up mark. We remain focused on

the successful and timely execution of our clinical trial but continue to lay the operational groundwork for an exciting future with tremendous

value creation potential. Should we receive approval to market our device, we believe that the demand will be substantial and we want

to be prepared to support that demand quickly and with tremendous success.”

Corporate and Financial Highlights for Q2 2026:

● First

Module of Modular PMA Application Submitted to the FDA. The Company submitted the first 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. Unlike a traditional PMA, the modular pathway allows the Company to submit completed sections for review

as they become available, enabling earlier FDA engagement, iterative feedback, and a defined cadence of milestones. The Company expects

to submit a total of four modules, with the final module containing final clinical trial data targeted for submission in the second quarter

of 2027.

● Expanded

Intellectual Property Portfolio. The Australian and European patent offices granted the Company four patents relating to important

innovations in implantable system design, signal analysis, and battery recharge safety, further strengthening the Company’s intellectual

property position in the implantable medical device and cochlear implant industries.

● At-the-Market

(ATM) Equity Facility Terminated. The Company terminated its ATM equity offering program, under which it was previously authorized

to offer and sell up to $15 million of its common stock.

Highlights Subsequent to Q2 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.

Financial Results for the Quarter Ended June 30, 2026 (dollars in

thousands):

Net revenue was $51 for the three months ended June 30, 2026.

Cost of goods sold for the three months ended June 30, 2026, was $278,

compared to $234 for the three months ended June 30, 2025.

R&D expenses for the three months ended June 30, 2026, were $3,132

compared to $2,485 for the three months ended June 30, 2025. This increase of $647 mainly reflects additional clinical trial follow-up

activity as a result of the clinical trial being fully enrolled, fees related to the submission of the first module of the Company’s

PMA application, and personnel costs related to the clinical trial.

Sales and marketing expenses for the three months ended June 30, 2026,

were $181 compared to $361 for the three months ended June 30, 2025. The decrease of $180 is primarily due to the reallocation of resources

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

General and administrative expenses were $2,029 for the three months

ended June 30, 2026, compared to $2,068 for the three months ended June 30, 2025. The decrease of $39 was primarily due to a severance

accrual in the prior-year period, partially offset by higher consulting and professional service fees.

Net loss attributable to common stockholders was $7,272, or $0.07 per

basic and diluted share for the three months ended June 30, 2026, compared to net loss attributable to common stockholders of $6,942,

or $0.32 per basic and diluted share for the three months ended June 30, 2025.

As of June 30, 2026, cash was approximately $19,679.

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 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.

2

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 operational improvements and capital investments; the ability to obtain additional patents and develop future

products or product improvements; the Acclaim CI being the first to market fully implanted cochlear implant; the timing, content, and

results of the Company’s modular PMA submissions to the FDA, including the number and timing of modules and the timing of any approval

decision; the timing and results of approvals, site documents, logistics, activations, enrollments, follow-up visits, data, and clinical

trials of the Acclaim CI, including data from Stage 2 (which may differ from Stage 1); the results of the safety and efficacy data from

Stage 2 participants and the effect on its pooling with Stage 1 data; performance of the Acclaim CI during clinical trials, including

improvement of patient outcomes over time after implant; and the participation or any changes in participation of any subjects, institutions,

or healthcare professionals in such trials; the safety, performance, and market acceptance of the Acclaim CI; changes in reimbursement

for the Esteem FI-AMEI device or other changes in reimbursement policies or coverage decisions, changes in the hearing health market,

and further development of the Esteem FI-AMEI device; the sufficiency of the Company’s capital resources; 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; 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

3

ENVOY MEDICAL, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(UNAUDITED)

(In thousands, except share and per share amounts)

June 30,

December 31,

2026

2025

(unaudited)

Current assets:

Cash

$ 19,679

$ 3,739

Accounts receivable, net

49

34

Other receivable

17

19

Inventories

1,579

1,546

Prepaid expenses and other current assets

593

941

Total current assets

21,917

6,279

Property and equipment, net

921

1,035

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

818

886

Prepaid expenses and other assets

293

358

Total assets

$ 23,949

$ 8,558

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

Current liabilities:

Accounts payable

$ 2,035

$ 2,920

Accrued expenses

10,032

7,639

Forward purchase agreement warrant liability

14

24

Product warranty liability, current portion

255

287

Operating lease liability, current portion (related party)

132

174

Other current liabilities

166

518

Total current liabilities

12,634

11,562

Product warranty liability, net of current portion

1,543

1,605

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

678

745

Private warrant liability

4,668

5,835

Publicly traded warrant liability

705

551

Other liability

27

27

Total liabilities

20,255

20,325

Commitments and contingencies (see Note 14)

Mezzanine equity

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

391

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 June 30, 2026 and December 31, 2025; 4,126,667 shares issued and outstanding as of June 30, 2026 and December 31, 2025

-

-

Class A Common Stock, $0.0001 par value; 400,000,000 shares authorized as of June 30, 2026 and December 31, 2025; 77,194,595 shares issued and outstanding as of June 30, 2026 and 28,934,960 shares issued and outstanding as of December 31, 2025

8

3

Additional paid-in capital

329,786

301,355

Accumulated deficit

(326,369 )

(313,396 )

Accumulated other comprehensive loss

(122 )

(120 )

Total stockholders’ equity (deficit)

3,303

(12,158 )

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

$ 23,949

$ 8,558

4

ENVOY MEDICAL, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

AND COMPREHENSIVE LOSS

(UNAUDITED)

(In thousands, except share and per share amounts)

Three Months Ended

June 30,

Six Months Ended

June 30,

2026

2025

2026

2025

Net revenues

$ 51

$ 78

$ 90

$ 124

Costs and operating expenses:

Cost of goods sold

278

234

591

460

Research and development

3,132

2,485

6,774

5,233

Sales and marketing

181

361

345

719

General and administrative

2,029

2,068

3,908

3,889

Total costs and operating expenses

5,620

5,148

11,618

10,301

Operating loss

(5,569 )

(5,070 )

(11,528 )

(10,177 )

Other income (expense):

Change in fair value of forward purchase agreement warrant liability

23

37

10

458

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

(838 )

-

1,167

-

Change in fair value of publicly traded warrant liability

236

(32 )

(154 )

162

Interest expense (related party)

-

(624 )

-

(1,119 )

Other income (expense), net

166

(1 )

172

(12 )

Total other income (expense), net

(413 )

(620 )

1,195

(511 )

Net loss

(5,982 )

(5,690 )

(10,333 )

(10,688 )

Cumulative preferred dividends

(1,290 )

(1,252 )

(2,640 )

(2,490 )

Net loss attributable to common stockholders, basic and diluted

$ (7,272 )

$ (6,942 )

$ (12,973 )

$ (13,178 )

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

$ (0.07 )

$ (0.32 )

$ (0.15 )

$ (0.62 )

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

104,039,109

21,383,852

86,584,007

21,355,388

Other comprehensive (loss) income:

Foreign currency translation adjustment

(1 )

(2 )

(2 )

4

Other comprehensive (loss) income

(1 )

(2 )

(2 )

4

Comprehensive loss

$ (5,983 )

$ (5,692 )

$ (10,335 )

$ (10,684 )

5

ENVOY MEDICAL, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

(Dollars in thousands)

Six Months Ended

June 30,

2026

2025

Cash flows from operating activities

Net loss

$ (10,333 )

$ (10,688 )

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

Depreciation

147

146

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

-

1,118

Stock-based compensation for services

76

-

Amortization of prepaid insurance

463

493

Stock-based compensation

453

306

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

(1,167 )

-

Change in fair value of publicly traded warrant liability

154

(162 )

Change in fair value of forward purchase agreement warrant liability

(10 )

(458 )

Net change in operating lease (related party)

111

51

Change in inventory reserve

26

10

Changes in operating assets and liabilities:

Accounts receivable, net

(15 )

(5 )

Other receivable

2

760

Inventories

(59 )

111

Prepaid expenses and other assets

40

(42 )

Accounts payable

(912 )

(33 )

Operating lease liability (related party)

(152 )

(44 )

Accrued expenses

(247 )

312

Product warranty liability

(94 )

(60 )

Net cash used in operating activities

(11,517 )

(8,185 )

Cash flows from investing activities

Purchases of property and equipment

(6 )

(7 )

Net cash used in investing activities

(6 )

(7 )

Cash flows from financing activities

Payments on insurance financing loans

(421 )

(469 )

Proceeds from the issuance of Term Loans (related party)

-

10,000

Dividends paid to stockholders of Series A Preferred Stock

-

(1,820 )

Proceeds from the issuance of Class A Common Stock from ATM offering

-

204

Proceeds from issuance of Class A Common Stock under employee stock purchase plan

104

77

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

27,465

7,992

Effect of exchange rate changes on cash

(2 )

4

Net increase (decrease) in cash

15,940

(196 )

Cash, beginning of period

3,739

5,483

Cash, end of period

$ 19,679

$ 5,287

Supplemental disclosures of cash flow information:

Cash paid for interest

$ 17

$ 20

Non-cash investing and financing activities:

Accrued and unpaid dividends on Series A Preferred Stock

$ 2,640

$ 670

Financing of prepaid insurance

$ 69

$ 75

Issuance of Term Loan Warrants (related party)

$ -

$ 1,570

Accrued interest capitalized into term loans payable (related party)

$ -

$ 600

Property and equipment purchased on account

$ 27

$ -

Issuance of Placement Agent Warrants

$ 678

$ -

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Name of the state or province.

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A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.

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Indicate if registrant meets the emerging growth company criteria.

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Indicate if an emerging growth company has elected not to use the extended transition period for complying with any new or revised financial accounting standards.

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Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

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

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

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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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Local phone number for entity.

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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 13e-4(c) under the Exchange Act.

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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.

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Title of a 12(b) registered security.

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Name of the Exchange on which a security is registered.

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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.

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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.

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