Envoy Medical Marks Three-Year Anniversary of First Patient Receiving Its Breakthrough Fully Implanted Cochlear Implant
Envoy Medical (NASDAQ: COCH) marked the three-year anniversary of the first fully implanted cochlear implant, first implanted on October 24, 2022. The company noted positive patient reports from three Early Feasibility Study (EFS) participants and said all three surpass three years post‑implant.
Envoy said it received FDA permission to expand its pivotal clinical trial into the second and final stage and holds a Breakthrough Device Designation. The pivotal Acclaim cochlear implant study is enrolling at multiple U.S. sites, and Envoy emphasizes U.S.‑based headquarters and manufacturing.
Envoy Medical (NASDAQ: COCH) ha festeggiato il terzo anniversario del primo impianto cocleare completamente impiantato, avvenuto il 24 ottobre 2022. L'azienda ha riportato feedback positivi da tre partecipanti allo Early Feasibility Study (EFS) e ha dichiarato che tutti e tre oltrepassano i tre anni dall'impianto.
Envoy ha detto di aver ottenuto dall'FDA l'autorizzazione ad espandere il suo trial principale nella seconda e ultima fase e detiene una Breakthrough Device Designation. Lo studio chiave sull'impianto cocleare Acclaim è in corso di reclutamento presso più sedi negli Stati Uniti, e Envoy sottolinea la sede e la produzione negli Stati Uniti.
Envoy Medical (NASDAQ: COCH) conmemoró el tercer aniversario del primer implante coclear completamente implantado, realizado el 24 de octubre de 2022. La empresa señaló informes positivos de los tres participantes del Early Feasibility Study (EFS) y dijo que los tres superan los tres años desde el implante.
Envoy indicó que recibió permiso de la FDA para ampliar su ensayo pivotal a la segunda y última etapa y posee una Designación de Dispositivo Innovador. El estudio pivotal del implante coclear Acclaim está reclutando en múltiples sitios de EE. UU., y Envoy enfatiza su sede y fabricación con base en Estados Unidos.
Envoy Medical (NASDAQ: COCH)는 최초의 완전히 이식된 달팽이관 임플란트의 3주년을 기념했습니다. 이 임플란트는 2022년 10월 24일에 처음 이식되었습니다. 회사는 Early Feasibility Study(EFS) 참가자 3명의 환자 보고가 긍정적이며 이들 모두가 이식 후 3년을 넘겼다고 밝혔습니다.
Envoy는 중요한 임상시험을 두 번째이자 최종 단계로 확장하기 위한 FDA의 승인을 받았다고 말했고, Breakthrough Device Designation를 보유하고 있습니다. Acclaim 달팽이관 임플란트 연구는 미국의 여러 사이트에서 모집 중이며, Envoy는 미국에 본사와 제조를 두고 있음을 강조합니다.
Envoy Medical (NASDAQ: COCH) a célébré le troisième anniversaire du premier implant cocléaire entièrement implanté, réalisé le 24 octobre 2022. La société a signalé des retours positifs de trois participants à l'étude de faisabilité précoce (EFS) et a déclaré que les trois dépassent les trois ans après l'implant.
Envoy a déclaré avoir obtenu l'autorisation de la FDA d'étendre son essai pivot à la deuxième et dernière étape et détient une Designation de dispositif innovant. L'étude pivot sur l'implant cocléaire Acclaim est en cours de recrutement sur plusieurs sites aux États-Unis, et Envoy met l'accent sur le siège et la fabrication basés aux États-Unis.
Envoy Medical (NASDAQ: COCH) hat den dreijährigen Jahrestag des ersten vollständig implantierten Cochlea-Implantats gefeiert, das am 24. Oktober 2022 erstmals eingesetzt wurde. Das Unternehmen verzeichnete positive Berichte von drei Teilnehmern der Early Feasibility Study (EFS) und sagte, dass alle drei mehr als drei Jahre post-Implantation sind.
Envoy teilte mit, dass es die FDA‑Genehmigung erhalten habe, seinen ausschlaggebenden klinischen Versuch in die zweite und letzte Phase zu erweitern und hält eine Breakthrough Device Designation. Die pivotal Acclaim Cochlear-Implantat-Studie rekrutiert an mehreren Standorten in den USA, und Envoy hebt die US‑basierte Zentrale und Fertigung hervor.
Envoy Medical (NASDAQ: COCH) احتفل بالذكرى الثالثة لأول جهاز زراعة قوقعية كامل التحميل، الذي تم زرعه لأول مرة في 24 أكتوبر 2022. أشارت الشركة إلى تقارير مرضى إيجابية من ثلاثة مشاركين في دراسة الجدوى المبكرة (EFS) وقالت إن الثلاثة تجاوزوا ثلاث سنوات بعد الزرع.
قالت Envoy إنها حصلت على إذن من إدارة الغذاء والدواء الأمريكية لتوسيع تجربتها المحورية إلى المرحلة الثانية والأخيرة وتمتلك Designation of Breakthrough Device. دراسة زراعة القوقع Acclaim المحورية قيد التوظيف في عدة مواقع في الولايات المتحدة، وتؤكد Envoy على مقرها ومكان تصنيعها في الولايات المتحدة.
Envoy Medical (NASDAQ: COCH) 庆祝首个完全植入的耳蜗植入物三周年，首次植入日期为2022年10月24日。公司提到来自三名早期可行性研究（EFS）参与者的积极患者报告，称三人植入后均已超过三年。
Envoy 表示已获FDA许可将其关键临床试验扩展至第二阶段及最后阶段，并拥有一个突破性设备指定。该关键 Acclaim 耳蜗植入研究正在美国多地招募，Envoy 强调其总部及制造均在美国。
- FDA approved expansion to second and final pivotal trial stage
- Breakthrough Device Designation granted by FDA
- Pivotal Acclaim trial currently enrolling at multiple U.S. sites
- Headquarters and manufacturing located in the United States
- Device remains investigational and is not commercially available
- Early Feasibility Study included only three implanted patients
The Company looks to build on its recent momentum - receiving FDA approval to expand its pivotal clinical trial into the second and final stage
White Bear Lake, Minnesota--(Newsfile Corp. - October 29, 2025) - Envoy Medical, Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced the three-year anniversary of the first patient receiving its breakthrough first fully implanted cochlear implant. On October 24, 2022, Craig Eggert became the first patient in the world to be implanted with Envoy Medical's new investigational fully implanted cochlear implant. The implant was done by Dr. Colin Driscoll at Mayo Clinic (Rochester, MN) and programmed by Dr. Aniket Saoji as part of an Early Feasibility Study (EFS).
"This implant has truly changed my life," Craig Eggert shared. "I was suffering with not being able to hear enough with my hearing aids before getting this device. Being able to hear my wife and daughters' voices again and fully engage with people around me has been an incredible gift. I'm deeply grateful to the people who made this possible. The entire experience has been overwhelmingly positive, and I can't wait for the opportunity to have my other ear done once it becomes commercially available."*
Three patients in total were implanted in the Early Feasibility Study, which was the precursor study to the currently enrolling pivotal clinical trial. All three EFS patients will surpass their three-year anniversary this fall. All three have reported a net positive impact and have expressed interest in getting their other ear implanted in the future.
"It is an incredible boost of confidence to be three years beyond the very first implants and listen to the patients report positive impact on their lives," said Brent Lucas, Chief Executive Officer of Envoy Medical. "Each one of them has said they would not only do it again but also shared their desire to have their other ear implanted in the future. For me, it doesn't get much better than that. We are now enrolling our final stage of the pivotal clinical study, and the interest being reported by the sites is overwhelming. We are grateful to have received the Breakthrough Device Designation by the FDA, because, clearly, patients and professionals want to see a device like ours on the market as soon as possible."
Envoy Medical is distinctly positioned within the hearing device market. Unlike most competitors in the hearing industry, Envoy Medical is an American company with both its headquarters and its manufacturing operations fully within the United States. As American policymakers increasingly prioritize domestic medical device production, Envoy Medical is already aligned with this strategic shift, strengthening its future with a long-term competitive advantage and enhancing shareholder value through operational efficiency, supply chain independence, and long-term competitive advantage.
The pivotal clinical trial for the fully implanted Acclaim cochlear implant is currently enrolling at multiple clinical sites nationwide. More information can be found at https://www.clinicaltrials.gov/study/NCT06699797.
*The information presented or discussed is investigational and for general educational purposes only and may not be representative of all or typical outcomes. It is not intended to be a substitute for professional medical advice and should not be interpreted to contain diagnostic or treatment recommendations. Each person's situation is unique, and risks, precautions, warnings, outcomes, and results may vary. Mr. Eggert received reimbursement from Envoy Medical for travel costs and received the device at no cost through participation in an early feasibility clinical study. He was not paid for sharing his experience.
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 and maintain compliance with Nasdaq rules and requirements; the timing and future outcome of its FDA pivotal trial; the amount of capital required to complete the FDA pivotal trial; the ability to add surgical sites, and the effect of adding such sites; 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 31, 2025, 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
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/272300
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