First Two Participants Successfully Enrolled In Pivotal Clinical Study For Breakthrough Fully Implanted Cochlear Implant
Envoy Medical (NASDAQ: COCH) has successfully enrolled the first two participants in its pivotal clinical study for the fully implanted Acclaim® cochlear implant. The study aims to evaluate safety and efficacy to support premarket approval (PMA). Both participants were implanted at Ear and Hearing | Center for Neurosciences in Tucson, Arizona by Dr. Abraham Jacob.
The Acclaim® device, which received FDA Breakthrough Device Designation in 2019, functions without external components, potentially offering a significant advantage over traditional cochlear implants. The device was previously implanted in three participants during an early feasibility study at Mayo Clinic in 2022. The current pivotal study involves seven investigational sites total.
According to CEO Brent Lucas, the company has implemented several device modifications based on learnings from the early feasibility study, while maintaining their fundamental design architecture.
Envoy Medical (NASDAQ: COCH) ha arruolato con successo i primi due partecipanti nel suo studio clinico cruciale per l'impianto cocleare Acclaim® completamente impiantato. Lo studio mira a valutare la sicurezza e l'efficacia per supportare l'approvazione pre-commercializzazione (PMA). Entrambi i partecipanti sono stati impiantati presso l'Ear and Hearing | Center for Neurosciences a Tucson, Arizona, dal Dr. Abraham Jacob.
Il dispositivo Acclaim®, che ha ricevuto la Designazione di Dispositivo Innovativo dalla FDA nel 2019, funziona senza componenti esterni, offrendo potenzialmente un vantaggio significativo rispetto agli impianti cocleari tradizionali. Il dispositivo era stato precedentemente impiantato in tre partecipanti durante uno studio di fattibilità precoce presso la Mayo Clinic nel 2022. L'attuale studio cruciale coinvolge un totale di sette siti investigativi.
Secondo il CEO Brent Lucas, l'azienda ha implementato diverse modifiche al dispositivo basate sugli insegnamenti dello studio di fattibilità precoce, mantenendo però la loro architettura di design fondamentale.
Envoy Medical (NASDAQ: COCH) ha inscrito con éxito a los primeros dos participantes en su estudio clínico pivotal para el implante coclear Acclaim® completamente implantado. El estudio tiene como objetivo evaluar la seguridad y la eficacia para respaldar la aprobación previa al mercado (PMA). Ambos participantes fueron implantados en el Ear and Hearing | Center for Neurosciences en Tucson, Arizona, por el Dr. Abraham Jacob.
El dispositivo Acclaim®, que recibió la Designación de Dispositivo Innovador de la FDA en 2019, funciona sin componentes externos, lo que podría ofrecer una ventaja significativa sobre los implantes cocleares tradicionales. El dispositivo había sido implantado anteriormente en tres participantes durante un estudio de viabilidad temprana en la Mayo Clinic en 2022. El estudio pivotal actual involucra un total de siete sitios de investigación.
Según el CEO Brent Lucas, la compañía ha implementado varias modificaciones al dispositivo basadas en las lecciones del estudio de viabilidad temprana, manteniendo su arquitectura de diseño fundamental.
Envoy Medical (NASDAQ: COCH)는 완전 임플란트된 Acclaim® 인공와우 이식기에 대한 주요 임상 연구에 첫 두 명의 참가자를 성공적으로 등록했습니다. 이 연구는 시장 출시 전 승인(PMA)을 지원하기 위해 안전성과 효능을 평가하는 것을 목표로 합니다. 두 참가자는 아리조나주 투손에 있는 Ear and Hearing | Center for Neurosciences에서 Dr. Abraham Jacob에 의해 이식되었습니다.
2019년에 FDA 혁신 장치 지정(Breakthrough Device Designation)을 받은 Acclaim® 장치는 외부 구성 요소 없이 작동하여 전통적인 인공와우 이식기에 비해 상당한 이점을 제공할 수 있습니다. 이 장치는 2022년 Mayo Clinic에서 진행된 초기 타당성 연구에서 세 명의 참가자에게 이전에 이식되었습니다. 현재의 주요 연구는 총 7개의 연구 사이트를 포함합니다.
CEO Brent Lucas에 따르면, 회사는 초기 타당성 연구에서 얻은 배움을 바탕으로 여러 장치 수정을 시행했으며, 기본 설계 구조는 유지하고 있습니다.
Envoy Medical (NASDAQ: COCH) a réussi à inscrire les deux premiers participants dans son étude clinique pivot pour l'implant cochléaire Acclaim® entièrement implanté. L'étude vise à évaluer la sécurité et l'efficacité pour soutenir l'approbation préalable à la mise sur le marché (PMA). Les deux participants ont été implantés au Ear and Hearing | Center for Neurosciences à Tucson, en Arizona, par le Dr Abraham Jacob.
Le dispositif Acclaim®, qui a reçu la désignation de Dispositif Innovant par la FDA en 2019, fonctionne sans composants externes, offrant potentiellement un avantage significatif par rapport aux implants cochléaires traditionnels. Le dispositif avait été préalablement implanté chez trois participants lors d'une étude de faisabilité précoce à la Mayo Clinic en 2022. L'étude pivot actuelle implique un total de sept sites d'investigation.
Selon le PDG Brent Lucas, la société a mis en œuvre plusieurs modifications du dispositif basées sur les enseignements de l'étude de faisabilité précoce, tout en maintenant leur architecture de conception fondamentale.
Envoy Medical (NASDAQ: COCH) hat erfolgreich die ersten beiden Teilnehmer in seiner entscheidenden klinischen Studie für das vollständig implantierte Acclaim®-Cochlea-Implantat eingeschrieben. Die Studie zielt darauf ab, Sicherheit und Wirksamkeit zu bewerten, um die Genehmigung vor der Markteinführung (PMA) zu unterstützen. Beide Teilnehmer wurden im Ear and Hearing | Center for Neurosciences in Tucson, Arizona, von Dr. Abraham Jacob implantiert.
Das Acclaim®-Gerät, das 2019 die FDA Breakthrough Device Designation erhielt, funktioniert ohne externe Komponenten und bietet potenziell einen erheblichen Vorteil gegenüber herkömmlichen Cochlea-Implantaten. Das Gerät wurde zuvor im Rahmen einer frühen Machbarkeitsstudie 2022 an der Mayo Clinic bei drei Teilnehmern implantiert. Die aktuelle entscheidende Studie umfasst insgesamt sieben Prüfstandorte.
Laut CEO Brent Lucas hat das Unternehmen mehrere Modifikationen am Gerät vorgenommen, die auf den Erkenntnissen aus der frühen Machbarkeitsstudie basieren, während die grundlegende Designarchitektur beibehalten wurde.
- FDA Breakthrough Device Designation status obtained
- Successfully completed early feasibility study with 3 participants
- Strong patient interest reported by study sites
- Potential competitive advantage with fully implanted design
- Still in clinical trial phase, no FDA approval yet
- Additional device modifications needed after early feasibility study
Insights
The initiation of Envoy Medical's pivotal clinical study for the fully implanted Acclaim® cochlear implant marks a important inflection point in hearing healthcare innovation. The successful enrollment of two participants, following the earlier feasibility study at Mayo Clinic, demonstrates meaningful progress toward commercialization. The FDA's Breakthrough Device Designation, granted in 2019, acknowledges both the innovative nature of the technology and its potential to address significant unmet medical needs.
The fully implanted design represents a fundamental shift in cochlear implant technology. Current market leaders like Cochlear , Advanced Bionics, and MED-EL require external processors, which can be stigmatizing and problematic for many patients. By eliminating external components, Envoy's approach could significantly expand market penetration, particularly among the estimated 80% of eligible candidates who currently decline traditional cochlear implants.
The expansion to seven investigational sites is strategically significant, suggesting confidence in the technology and preparation for larger-scale validation. The implementation of device modifications based on the early feasibility study demonstrates an iterative development approach that could accelerate the path to market while potentially establishing competitive advantages.
The connection between hearing loss and dementia risk adds another compelling dimension to the market opportunity. With an aging global population and increasing focus on preventive healthcare, a more acceptable and convenient cochlear implant solution could drive higher adoption rates among older adults - a demographic that traditionally shows lower utilization of hearing devices.
However, several critical factors warrant attention:
- The PMA pathway typically requires extensive safety and efficacy data, suggesting a significant timeline before potential commercialization
- The fully implanted design must demonstrate battery longevity and reliable performance to compete with established solutions
- Manufacturing scalability and cost considerations will be important for market penetration
The strong interest from potential candidates reported by study sites validates the market demand for less visible hearing solutions. If successful, this technology could reshape the $2.5 billion global cochlear implant market, particularly given the device's potential competitive advantages in user comfort and continuous hearing capability.
White Bear Lake, Minnesota--(Newsfile Corp. - February 24, 2025) - Envoy Medical®, Inc. (NASDAQ: COCH) ("Envoy Medical"), a hearing health company focused on providing hearing loss sufferers with innovative solutions today announces the successful enrollment of the first two participants in its pivotal clinical study. The purpose of the study is to investigate the safety and efficacy of the fully implanted Acclaim® cochlear implant and support its eventual premarket approval (PMA) application. If successful, the fully implanted Acclaim® cochlear implant could represent a paradigm shift in the cochlear implant industry and provide a significant business opportunity for Envoy Medical.
"We are excited to be underway with the highly-anticipated pivotal clinical study of the fully implanted Acclaim® cochlear implant," said Brent Lucas, CEO of Envoy Medical, "The high level of excitement around our fully implanted cochlear implant was expected, but it is still incredibly validating to hear study sites report a great deal of interest from potential candidates. It appears, perhaps unsurprisingly, that many potential cochlear implant candidates would prefer a cochlear implant that can function without bulky externals."
Both study participants were implanted at Ear and Hearing | Center for Neurosciences in Tucson, Arizona by Dr. Abraham Jacob.
"Hearing loss is the most common human sensory disability and a modifiable risk factor for dementia," said Dr. Jacob, "With no external processor and the potential for always-on hearing, the successful implantation of two patients at our center sets the fully implanted Acclaim cochlear implant system as a new benchmark within the hearing healthcare space."
In addition to the Ear and Hearing | Center for Neurosciences in Tucson, Arizona, six other investigational sites were selected to be part of the study. A full list of investigational sites and additional information on the Acclaim® pivotal clinical study can be found HERE.
The fully implanted Acclaim® cochlear implant received Breakthrough Device Designation from the FDA in 2019 and was first implanted in three participants during an early feasibility study (EFS) at Mayo Clinic in Rochester, Minnesota in 2022.
"Over the last two years, we have learned a great deal from our early feasibility study and have been able to implement several device modifications for this pivotal clinical trial," said Lucas, "We strongly believe our fundamental design architecture is the right way to approach fully implanted cochlear implants and may provide our device with several competitive advantages, but as a responsible medical device company, we will seek ways to continuously improve what is already a breakthrough device."
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 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, product and component availability and performance, the timing and results of clinical trials of the Acclaim CI, and enrollment and the participation of any institution in such trials; the safety, performance, and market acceptance of the Acclaim CI; 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 April 1, 2024, 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.
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FAQ
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