{"success":true,"data":{"pressRelease":{"id":"166382","rtpr_id":"nNFC8Vdz3k-20261012","ticker":"COCH","exchange":"NASDAQ","all_tickers":["COCH"],"title":"Envoy Medical Submits Second Module of Modular Premarket Approval Application to FDA for Breakthrough Designated Acclaim(R) Cochlear Implant","author":"Newsfile Corp","published_at":"2026-10-12T12:30:17.569Z","article_body":"Second of Four Planned Modules Moves Rolling FDA Review Forward\n\nAdvances Toward Targeted Completion of the Final Clinical Module Submission in\nQ2 2027\n\nWhite Bear Lake, Minnesota--(Newsfile Corp. - October 12, 2026) - Envoy\nMedical (https://api.newsfilecorp.com/redirect/87YyXi57rx)® Inc. (NASDAQ:\nCOCH) (\"Envoy Medical\" or the \"Company\"), a hearing health and\nneuroprosthetics company pioneering fully implanted hearing solutions, today\nannounced the submission of the second module of its Modular Premarket\nApproval (\"PMA\") application to the U.S. Food and Drug Administration (\"FDA\")\nfor the Acclaim® cochlear implant, which has received FDA Breakthrough Device\nDesignation.\n\nThe second module, which included primarily engineering information, follows\nthe Company's submission of the first module on June 30, 2026. Envoy Medical\nexpects to submit a total of four modules on a rolling basis, with the final\nmodule containing final clinical trial data and completing the PMA\napplication.\n\n\"The submission of our second module is an important milestone that\ndemonstrates measurable progress,\" said Brent Lucas, Chief Executive Officer\nof Envoy Medical. \"With two of the four modules submitted, we continue to\nsteadily march along our defined regulatory pathway.\"\n\nWhat the second module submission means for Envoy Medical:\n*\nProgress on a rolling timeline: Half of the planned modules are now with the\nFDA, allowing the agency to review submitted sections while clinical data\ncollection continues.\n*\nContinued FDA dialogue: Each submitted module provides another opportunity for\nthe Company to receive feedback and address questions before the final\nsubmission.\n*\nRemaining milestones: The Company expects to submit two additional modules,\nincluding the final module containing clinical trial data, towards the end of\nthe second quarter in 2027.\n\nThe fully implanted Acclaim® cochlear implant received Breakthrough Device\nDesignation from the FDA in 2019 and is currently under investigation as part\nof a U.S.-based pivotal clinical trial. For more information on the trial,\nvisit www.envoymedical.com/acclaim-pivotal.\n\nTo be added to the Envoy Medical email distribution list, please email\nEnvoy@kcsa.com with COCH in the subject line.\n\nAbout Envoy Medical, Inc.\n\nEnvoy Medical (NASDAQ: COCH) is a hearing health and neuroprosthetics company\nfocused on providing innovative technologies across the hearing loss spectrum.\nEnvoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing\nloss, including its fully implanted Esteem® active middle ear implant,\ncommercially available in the U.S. since 2010, and the fully implanted\nAcclaim® cochlear implant, an investigational device. Envoy Medical is\ndedicated to pushing hearing technology beyond the status quo to improve\naccess, usability, compliance, and ultimately quality of life.\n\nAbout the Fully Implanted Acclaim® Cochlear Implant\n\nWe believe the fully implanted Acclaim Cochlear Implant (\"Acclaim CI\") is a\nfirst-of-its-kind hearing device. Envoy Medical's fully implanted technology\nincludes a sensor designed to leverage the natural anatomy of the ear instead\nof a microphone to capture sound.\n\nThe Acclaim CI is designed to address severe to profound sensorineural hearing\nloss that is not adequately addressed by hearing aids. The Acclaim CI is\nexpected to be indicated for adults who have been deemed adequate candidates\nby a qualified physician.\n\nThe Acclaim Cochlear Implant received the Breakthrough Device Designation from\nthe U.S. Food and Drug Administration (FDA) in 2019.\n\nCAUTION The fully implanted Acclaim Cochlear Implant is an investigational\ndevice. Limited by Federal (or United States) law to investigational use.\n\nAbout the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI)\n\nThe Esteem fully implanted active middle ear implant (FI-AMEI) is the only\nFDA-approved, fully implanted hearing device for adults diagnosed with\nmoderate to severe sensorineural hearing loss allowing for 24/7 hearing\ncapability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant\nis invisible and requires no externally worn components and nothing is placed\nin the ear canal for it to function. Unlike hearing aids, you never put it on\nor take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI\nhearing implant offers true 24/7 hearing.\n\nImportant safety information for the Esteem FI-AMEI can be found at:\nhttps://www.envoymedical.com/safety-information.\n\nAdditional Information and Where to Find It\n\nCopies of the documents filed by Envoy Medical with the SEC may be obtained\nfree of charge at the SEC's website at www.sec.gov.\n\nForward-Looking Statements\n\nThis press release includes \"forward-looking statements\" within the meaning of\nthe \"safe harbor\" provisions of the United States Private Securities\nLitigation Reform Act of 1995. Forward-Looking statements may be identified by\nthe use of words such as \"estimate,\" \"plan,\" \"project,\" \"forecast,\" \"intend,\"\n\"will,\" \"expect,\" \"anticipate,\" \"believe,\" \"seek,\" \"target\" or other similar\nexpressions that predict or indicate future events or trends or that are not\nstatements of historical matters, but the absence of these words does not mean\nthat a statement is not forward-looking. Such statements may include, but are\nnot limited to, statements regarding the expectations of Envoy Medical\nconcerning the outlook for its business, productivity, plans and goals for\nfuture operations; the ability to obtain additional patents and develop future\nproducts or product improvements; the ability to maintain compliance with\nNasdaq rules and requirements; the timing and future outcome of its FDA\npivotal trial; the ability to raise capital and the amount of capital required\nto complete the FDA pivotal trial and early commercialization; the Acclaim CI\nbeing the first to market fully implanted cochlear implant; the timing and\nresults of activations, enrollments, follow-up visits, data, and clinical\ntrials of the Acclaim CI; performance of the Acclaim CI during clinical\ntrials, including improvement of patient outcomes over time after implant; and\nthe participation or any changes or delays in participation of any subjects,\ninstitutions, or healthcare professionals in such trials; the safety,\nperformance, and market acceptance of the Acclaim CI; the timing and results\nof the Acclaim CI's PMA submissions to the FDA, including modular submissions\nand related feedback; the size of Envoy Medical's addressable market,\noperational performance, future market conditions or economic performance and\ndevelopments in the capital and credit markets; and any information concerning\npossible or assumed future operations of Envoy Medical. The forward-looking\nstatements contained in this press release reflect Envoy Medical's current\nviews about future events and are subject to numerous known and unknown risks,\nuncertainties, assumptions and changes in circumstances that may cause its\nactual results to differ significantly from those expressed in any\nforward-looking statement. Envoy Medical does not guarantee that the events\ndescribed will happen as described (or that they will happen at all). These\nforward-looking statements are subject to a number of risks and uncertainties,\nincluding, but not limited to changes in the market price of shares of Envoy\nMedical's Class A Common Stock; changes in or removal of Envoy Medical's\nshares inclusion in any index; Envoy Medical's success in retaining or\nrecruiting, or changes required in, its officers, key employees or directors;\nunpredictability in the medical device industry, the regulatory process to\napprove medical devices, and the clinical development process of Envoy Medical\nproducts; the ability to engage competition in the medical device industry,\nand the failure to introduce new products and services in a timely manner or\nat competitive prices to compete successfully against competitors; disruptions\nin relationships with Envoy Medical's suppliers, or disruptions in Envoy\nMedical's own production capabilities for some of the key components and\nmaterials of its products; changes in the need for capital and the\navailability of financing and capital to fund these needs; changes in interest\nrates or rates of inflation; legal, regulatory and other proceedings could be\ncostly and time-consuming to defend; changes in applicable laws or\nregulations, or the application thereof on Envoy Medical; a loss of any of\nEnvoy Medical's key intellectual property rights or failure to adequately\nprotect intellectual property rights; the effects of catastrophic events,\nincluding war, terrorism and other international conflicts; and other risks\nand uncertainties set forth in the section entitled \"Risk Factors\" and\n\"Cautionary Note Regarding Forward-Looking Statements\" in the Annual Report on\nForm 10-K filed by Envoy Medical on March 23, 2026, and in other reports Envoy\nMedical files, with the SEC. If any of these risks materialize or Envoy\nMedical's assumptions prove incorrect, actual results could differ materially\nfrom the results implied by these forward-looking statements. While\nforward-looking statements reflect Envoy Medical's good faith beliefs, they\nare not guarantees of future performance. Envoy Medical disclaims any\nobligation to publicly update or revise any forward-looking statement to\nreflect changes in underlying assumptions or factors, new information, data or\nmethods, future events or other changes after the date of this press release,\nexcept as required by applicable law. You should not place undue reliance on\nany forward-looking statements, which are based only on information currently\navailable to Envoy Medical.\n\nInvestor Contact:\n\nPhil Carlson\nKCSA Strategic Communications\nO: 212.896.1233\nE: Envoy@kcsa.com\n\n\nTo view the source version of this press release, please visit\nhttps://www.newsfilecorp.com/release/318503","article_body_html":"","raw_payload":{"data":{"id":"nNFC8Vdz3k-20261012","title":"Envoy Medical Submits Second Module of Modular Premarket Approval Application to FDA for Breakthrough Designated Acclaim(R) Cochlear Implant","author":"Newsfile Corp","ticker":"COCH","created":"2026-10-12T12:30:17.569Z","tickers":["COCH"],"exchange":"NASDAQ","article_body":"Second of Four Planned Modules Moves Rolling FDA Review Forward\n\nAdvances Toward Targeted Completion of the Final Clinical Module Submission in\nQ2 2027\n\nWhite Bear Lake, Minnesota--(Newsfile Corp. - October 12, 2026) - Envoy\nMedical (https://api.newsfilecorp.com/redirect/87YyXi57rx)® Inc. (NASDAQ:\nCOCH) (\"Envoy Medical\" or the \"Company\"), a hearing health and\nneuroprosthetics company pioneering fully implanted hearing solutions, today\nannounced the submission of the second module of its Modular Premarket\nApproval (\"PMA\") application to the U.S. Food and Drug Administration (\"FDA\")\nfor the Acclaim® cochlear implant, which has received FDA Breakthrough Device\nDesignation.\n\nThe second module, which included primarily engineering information, follows\nthe Company's submission of the first module on June 30, 2026. Envoy Medical\nexpects to submit a total of four modules on a rolling basis, with the final\nmodule containing final clinical trial data and completing the PMA\napplication.\n\n\"The submission of our second module is an important milestone that\ndemonstrates measurable progress,\" said Brent Lucas, Chief Executive Officer\nof Envoy Medical. \"With two of the four modules submitted, we continue to\nsteadily march along our defined regulatory pathway.\"\n\nWhat the second module submission means for Envoy Medical:\n*\nProgress on a rolling timeline: Half of the planned modules are now with the\nFDA, allowing the agency to review submitted sections while clinical data\ncollection continues.\n*\nContinued FDA dialogue: Each submitted module provides another opportunity for\nthe Company to receive feedback and address questions before the final\nsubmission.\n*\nRemaining milestones: The Company expects to submit two additional modules,\nincluding the final module containing clinical trial data, towards the end of\nthe second quarter in 2027.\n\nThe fully implanted Acclaim® cochlear implant received Breakthrough Device\nDesignation from the FDA in 2019 and is currently under investigation as part\nof a U.S.-based pivotal clinical trial. For more information on the trial,\nvisit www.envoymedical.com/acclaim-pivotal.\n\nTo be added to the Envoy Medical email distribution list, please email\nEnvoy@kcsa.com with COCH in the subject line.\n\nAbout Envoy Medical, Inc.\n\nEnvoy Medical (NASDAQ: COCH) is a hearing health and neuroprosthetics company\nfocused on providing innovative technologies across the hearing loss spectrum.\nEnvoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing\nloss, including its fully implanted Esteem® active middle ear implant,\ncommercially available in the U.S. since 2010, and the fully implanted\nAcclaim® cochlear implant, an investigational device. Envoy Medical is\ndedicated to pushing hearing technology beyond the status quo to improve\naccess, usability, compliance, and ultimately quality of life.\n\nAbout the Fully Implanted Acclaim® Cochlear Implant\n\nWe believe the fully implanted Acclaim Cochlear Implant (\"Acclaim CI\") is a\nfirst-of-its-kind hearing device. Envoy Medical's fully implanted technology\nincludes a sensor designed to leverage the natural anatomy of the ear instead\nof a microphone to capture sound.\n\nThe Acclaim CI is designed to address severe to profound sensorineural hearing\nloss that is not adequately addressed by hearing aids. The Acclaim CI is\nexpected to be indicated for adults who have been deemed adequate candidates\nby a qualified physician.\n\nThe Acclaim Cochlear Implant received the Breakthrough Device Designation from\nthe U.S. Food and Drug Administration (FDA) in 2019.\n\nCAUTION The fully implanted Acclaim Cochlear Implant is an investigational\ndevice. Limited by Federal (or United States) law to investigational use.\n\nAbout the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI)\n\nThe Esteem fully implanted active middle ear implant (FI-AMEI) is the only\nFDA-approved, fully implanted hearing device for adults diagnosed with\nmoderate to severe sensorineural hearing loss allowing for 24/7 hearing\ncapability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant\nis invisible and requires no externally worn components and nothing is placed\nin the ear canal for it to function. Unlike hearing aids, you never put it on\nor take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI\nhearing implant offers true 24/7 hearing.\n\nImportant safety information for the Esteem FI-AMEI can be found at:\nhttps://www.envoymedical.com/safety-information.\n\nAdditional Information and Where to Find It\n\nCopies of the documents filed by Envoy Medical with the SEC may be obtained\nfree of charge at the SEC's website at www.sec.gov.\n\nForward-Looking Statements\n\nThis press release includes \"forward-looking statements\" within the meaning of\nthe \"safe harbor\" provisions of the United States Private Securities\nLitigation Reform Act of 1995. Forward-Looking statements may be identified by\nthe use of words such as \"estimate,\" \"plan,\" \"project,\" \"forecast,\" \"intend,\"\n\"will,\" \"expect,\" \"anticipate,\" \"believe,\" \"seek,\" \"target\" or other similar\nexpressions that predict or indicate future events or trends or that are not\nstatements of historical matters, but the absence of these words does not mean\nthat a statement is not forward-looking. Such statements may include, but are\nnot limited to, statements regarding the expectations of Envoy Medical\nconcerning the outlook for its business, productivity, plans and goals for\nfuture operations; the ability to obtain additional patents and develop future\nproducts or product improvements; the ability to maintain compliance with\nNasdaq rules and requirements; the timing and future outcome of its FDA\npivotal trial; the ability to raise capital and the amount of capital required\nto complete the FDA pivotal trial and early commercialization; the Acclaim CI\nbeing the first to market fully implanted cochlear implant; the timing and\nresults of activations, enrollments, follow-up visits, data, and clinical\ntrials of the Acclaim CI; performance of the Acclaim CI during clinical\ntrials, including improvement of patient outcomes over time after implant; and\nthe participation or any changes or delays in participation of any subjects,\ninstitutions, or healthcare professionals in such trials; the safety,\nperformance, and market acceptance of the Acclaim CI; the timing and results\nof the Acclaim CI's PMA submissions to the FDA, including modular submissions\nand related feedback; the size of Envoy Medical's addressable market,\noperational performance, future market conditions or economic performance and\ndevelopments in the capital and credit markets; and any information concerning\npossible or assumed future operations of Envoy Medical. The forward-looking\nstatements contained in this press release reflect Envoy Medical's current\nviews about future events and are subject to numerous known and unknown risks,\nuncertainties, assumptions and changes in circumstances that may cause its\nactual results to differ significantly from those expressed in any\nforward-looking statement. Envoy Medical does not guarantee that the events\ndescribed will happen as described (or that they will happen at all). These\nforward-looking statements are subject to a number of risks and uncertainties,\nincluding, but not limited to changes in the market price of shares of Envoy\nMedical's Class A Common Stock; changes in or removal of Envoy Medical's\nshares inclusion in any index; Envoy Medical's success in retaining or\nrecruiting, or changes required in, its officers, key employees or directors;\nunpredictability in the medical device industry, the regulatory process to\napprove medical devices, and the clinical development process of Envoy Medical\nproducts; the ability to engage competition in the medical device industry,\nand the failure to introduce new products and services in a timely manner or\nat competitive prices to compete successfully against competitors; disruptions\nin relationships with Envoy Medical's suppliers, or disruptions in Envoy\nMedical's own production capabilities for some of the key components and\nmaterials of its products; changes in the need for capital and the\navailability of financing and capital to fund these needs; changes in interest\nrates or rates of inflation; legal, regulatory and other proceedings could be\ncostly and time-consuming to defend; changes in applicable laws or\nregulations, or the application thereof on Envoy Medical; a loss of any of\nEnvoy Medical's key intellectual property rights or failure to adequately\nprotect intellectual property rights; the effects of catastrophic events,\nincluding war, terrorism and other international conflicts; and other risks\nand uncertainties set forth in the section entitled \"Risk Factors\" and\n\"Cautionary Note Regarding Forward-Looking Statements\" in the Annual Report on\nForm 10-K filed by Envoy Medical on March 23, 2026, and in other reports Envoy\nMedical files, with the SEC. If any of these risks materialize or Envoy\nMedical's assumptions prove incorrect, actual results could differ materially\nfrom the results implied by these forward-looking statements. While\nforward-looking statements reflect Envoy Medical's good faith beliefs, they\nare not guarantees of future performance. Envoy Medical disclaims any\nobligation to publicly update or revise any forward-looking statement to\nreflect changes in underlying assumptions or factors, new information, data or\nmethods, future events or other changes after the date of this press release,\nexcept as required by applicable law. You should not place undue reliance on\nany forward-looking statements, which are based only on information currently\navailable to Envoy Medical.\n\nInvestor Contact:\n\nPhil Carlson\nKCSA Strategic Communications\nO: 212.896.1233\nE: Envoy@kcsa.com\n\n\nTo view the source version of this press release, please visit\nhttps://www.newsfilecorp.com/release/318503"},"type":"article","timestamp":"2026-10-12T12:30:17.613631114Z","server_sent_at_ms":1791808217613},"received_at":"2026-10-12T12:30:17.664Z","source_url":"https://www.newsfilecorp.com/release/318503"},"analysis":{"id":"154741","press_release_id":"166382","analysis_json":{"industry":{"label":"Health Care Equipment & Supplies","sector":"Health Care"},"redFlags":["Final clinical module not expected until Q2 2027 — approval timeline remains long","Acclaim CI still investigational; pivotal trial data not yet complete"],"eventType":"regulatory","narrative":"Envoy Medical submitted the second of four planned modules of its Modular PMA application to the FDA for the Breakthrough Device-designated Acclaim cochlear implant.\n\nThe second module contained primarily engineering information and follows the first module submitted June 30, 2026; the final module with clinical trial data is targeted for the end of Q2 2027.\n\nThe submission marks steady regulatory progress on the rolling review, though approval remains more than a year away and hinges on the pivotal trial data still being collected.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Rolling PMA hits halfway mark for Envoy's fully implanted cochlear implant — a de-risking step, not a catalyst."},"keyFigures":{"drugName":"Acclaim Cochlear Implant","phaseOfTrial":"pivotal clinical trial","customDimensions":{"first_module_date":"June 30, 2026","modules_submitted":"2 of 4","final_module_target":"Q2 2027","breakthrough_designation_year":2019}},"quotedText":"The submission of our second module is an important milestone that demonstrates measurable progress","namedEntities":{"people":[{"name":"Brent Lucas","role":"CEO of Envoy Medical"},{"name":"Phil Carlson","role":"Investor Contact, KCSA Strategic Communications"}],"products":["Acclaim Cochlear Implant","Esteem active middle ear implant"],"companies":[{"name":"Envoy Medical, Inc.","ticker":"COCH","relationship":"filer"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"},{"name":"KCSA Strategic Communications","relationship":"investor relations"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"Routine progress milestone in an ongoing rolling PMA review — second of four modules submitted, mostly engineering data. Approval is not yet in sight; final clinical module not due until Q2 2027."},"tickerRelevance":{"others":[],"primary":"COCH"},"globalImportance":22,"audienceRelevance":18,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"micro-cap","eventGravity":"routine regulatory milestone","issuerAuthored":true}},"event_type":"regulatory","event_type_secondary":null,"sentiment":"bullish","material_impact_score":2,"narrative":"Envoy Medical submitted the second of four planned modules of its Modular PMA application to the FDA for the Breakthrough Device-designated Acclaim cochlear implant.\n\nThe second module contained primarily engineering information and follows the first module submitted June 30, 2026; the final module with clinical trial data is targeted for the end of Q2 2027.\n\nThe submission marks steady regulatory progress on the rolling review, though approval remains more than a year away and hinges on the pivotal trial data still being collected.","key_figures":{"drugName":"Acclaim Cochlear Implant","phaseOfTrial":"pivotal clinical trial","customDimensions":{"first_module_date":"June 30, 2026","modules_submitted":"2 of 4","final_module_target":"Q2 2027","breakthrough_designation_year":2019}},"named_entities":{"people":[{"name":"Brent Lucas","role":"CEO of Envoy Medical"},{"name":"Phil Carlson","role":"Investor Contact, KCSA Strategic Communications"}],"products":["Acclaim Cochlear Implant","Esteem active middle ear implant"],"companies":[{"name":"Envoy Medical, Inc.","ticker":"COCH","relationship":"filer"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"},{"name":"KCSA Strategic Communications","relationship":"investor relations"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-12T12:30:23.949Z","global_importance":22,"audience_relevance":18,"importance_components":{"tickerTier":"micro-cap","eventGravity":"routine regulatory milestone","issuerAuthored":true}},"durationMs":6269,"modelName":"glm-5.3-flashx"}}