<p>2024 年 11 月 12 日- 上午 09:25</p>
<p><em>耳科学与神经耳科学研究概述了突破性全植入式人工耳蜗的早期经验和潜在好处</em></p>
<p><em>明尼苏达州白熊湖，2024 年 11 月 12 日（全球新闻稿）--</em> Envoy Medical®, Inc.（“Envoy Medical”）（纳斯达克：“COCH”），一家专注于全植入式听力系统的听力健康公司，今天宣布在_耳科学与神经耳科学_上发表了一篇经过同行评审的论文，讨论了与公司正在研究的全植入式 Acclaim <strong>®</strong> 人工耳蜗（Acclaim CI）的早期经验，并强调其潜在好处。该论文标题为 “新型全植入式人工耳蜗的早期听力结果和听力学经验”，讨论了一项首次在人类中进行的早期可行性研究的初步结果。该研究在收集和分析这些数据时仅进行了六个月。所有三名患者目前都已植入近两年。</p>
<p>“这篇出版物开始指出全植入式人工耳蜗的潜在现实世界好处。听力损失伴随你一整天——你无法摘掉或关闭你的听力损失——因此，能够在一天中随时接触声音的全植入式听力解决方案的潜在好处让许多患者感到兴奋。我们对参与研究这一突破性设备的三名患者表示感谢。我们学到了很多，并期待将这些经验应用于我们最近获得 FDA 批准开始的关键临床试验中的更大患者群体，” Envoy Medical 首席执行官 Brent Lucas 说道。</p>
<p>主要亮点包括：</p>
<ul>
<li>所有接受者都是其设备的常规用户。一名患者报告称其设备持续使用（昼夜不息），研究作者认为这可能支持改善言语和生活质量的结果。</li>
<li>三名患者中有两名报告称通过在与人工耳蜗相同的耳朵中使用助听器来优化其听力收益。这种灵活性和选择性可能对潜在用户带来现实生活中的好处。Acclaim CI 设计为利用耳朵捕捉声音，这为助听器、耳塞或其他消费电子设备在植入耳中使用提供了机会。</li>
<li>所有患者报告在一次充电后使用时间在三到五天之间。</li>
<li>作者指出该设备可以在夜间使用，这可能为患者提供了一种安全感，而这种安全感是部分植入设备在夜间移除外部组件时无法提供的。</li>
</ul>
<p><strong>关于全植入式 Acclaim®人工耳蜗</strong></p>
<p>我们相信全植入式 Acclaim 人工耳蜗（“Acclaim CI”）是首个此类听力设备。Envoy Medical 的全植入式技术包括一个传感器，旨在利用耳朵的自然解剖结构，而不是麦克风来捕捉声音。</p>
<p>Acclaim CI 旨在解决严重到极重度的感音神经性听力损失，而这种损失无法通过助听器得到充分解决。Acclaim CI 预计将适用于被合格医生评估为合适候选人的成年人。</p>
<p>Acclaim 人工耳蜗于 2019 年获得美国食品和药物管理局（FDA）的突破性设备认证。</p>
<p><strong>警告 全植入式 Acclaim 人工耳蜗是一种研究性设备。根据联邦（或美国）法律，仅限于研究使用。</strong></p>
<p><strong>关于 Esteem®全植入式主动中耳植入物（FI-AMEI）</strong></p>
<p>Esteem 全植入式主动中耳植入物（FI-AMEI）是唯一获得 FDA 批准的全植入式 * 听力设备，适用于被诊断为中度至重度感音神经性听力损失的成年人，允许使用耳朵的自然解剖结构实现 24/7 的听力能力。Esteem FI-AMEI 听力植入物是隐形的，不需要外部佩戴的组件，也不需要在耳道中放置任何东西以使其正常工作。与助听器不同，你永远不需要佩戴或摘下它。你无法丢失它。你不需要清洁它。Esteem FI-AMEI 听力植入物提供真正的 24/7 听力。</p>
<p>* 一旦激活，外部 Esteem FI-AMEI 个人编程器在日常使用中不再需要。</p>
<p>有关 Esteem FI-AMEI 的重要安全信息，请访问：https://www.envoymedical.com/safety-information。</p>
<p><strong>附加信息及获取途径</strong></p>
<p>Envoy Medical 向 SEC 提交的文件副本可在 SEC 网站 www.sec.gov 免费获取。</p>
<p><strong>前瞻性声明</strong></p>
<p>本新闻稿包含根据 1995 年美国私人证券诉讼改革法案的 “安全港” 条款定义的 “前瞻性声明”。前瞻性声明可以通过使用诸如 “估计”、“计划”、“项目”、“预测”、“打算”、“将”、“期望”、“预期”、“相信”、“寻求”、“目标” 或其他类似表达来识别，这些词预测或指示未来事件或趋势，或者不是历史事项的陈述，但缺乏这些词并不意味着该声明不是前瞻性的。这些声明可能包括但不限于关于 Envoy Medical 对其业务前景、生产力、未来运营改进和资本投资计划及目标的期望；Acclaim CI 作为市场上首个完全植入的人工耳蜗；Acclaim CI 的安全性、性能和市场接受度；以及关于 Envoy Medical 可能或假定的未来运营的任何信息。本新闻稿中包含的前瞻性声明反映了 Envoy Medical 对未来事件的当前看法，并受到众多已知和未知风险、不确定性、假设和情况变化的影响，这些因素可能导致其实际结果与任何前瞻性声明中表达的结果显著不同。Envoy Medical 不保证所描述的事件会如所述发生（或会发生）。这些前瞻性声明面临许多风险和不确定性，包括但不限于 Envoy Medical A 类普通股的市场价格变化；Envoy Medical 股票在任何指数中的纳入变化或移除；Envoy Medical 在保留或招聘其高管、关键员工或董事方面的成功，或所需的变更；医疗器械行业的不可预测性、批准医疗器械的监管过程以及 Envoy Medical 产品的临床开发过程；医疗器械行业的竞争，以及未能及时以具有竞争力的价格推出新产品和服务以成功与竞争对手竞争；与 Envoy Medical 供应商的关系中断，或 Envoy Medical 自身在其产品的一些关键组件和材料的生产能力中断；资本需求的变化及融资和资本的可用性变化；利率或通货膨胀率的变化；法律、监管和其他诉讼可能会耗费高昂的成本和时间进行辩护；适用法律或法规的变化，或其在 Envoy Medical 上的适用；Envoy Medical 任何关键知识产权的丧失或未能充分保护知识产权；灾难性事件的影响，包括战争、恐怖主义和其他国际冲突；以及 Envoy Medical 在 2024 年 4 月 1 日提交的 10-K 表格年报中 “风险因素” 和 “关于前瞻性声明的警示说明” 部分中列出的其他风险和不确定性。如果这些风险中的任何一个实现，或 Envoy Medical 的假设被证明不正确，实际结果可能与这些前瞻性声明所暗示的结果有重大差异。虽然前瞻性声明反映了 Envoy Medical 的善意信念，但它们并不是未来表现的保证。Envoy Medical 不承担任何公开更新或修订任何前瞻性声明的义务，以反映基础假设或因素、新信息、数据或方法、未来事件或本新闻稿日期后的其他变化，除非适用法律要求。您不应对任何前瞻性声明过度依赖，这些声明仅基于 Envoy Medical 当前可用的信息。</p>
<h3></h3>
<p><strong>投资者联系：</strong></p>
<p>CORE IR</p>
<p>516-222-2560</p>
<p>investorrelations@envoymedical.com</p>
<p><img src="https://imageproxy.pbkrs.com/https://www.globenewswire.com/newsroom/ti/query-bmY9T1RJM01UVXhPU00yTlRjMk5qYzJJelV3TURFeE9UVXlPQT09?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://www.globenewswire.com/newsroom/ti/query-bmY9T1RJM01UVXhPU00yTlRjMk5qYzJJelV3TURFeE9UVXlPQT09"/></p>
<p><img src="https://imageproxy.pbkrs.com/https://ml.globenewswire.com/media/YzBmOGE3OGQtNDBmOC00OWY0LWE1MWQtMTc5NGFlMGI4Y2JhLTUwMDExOTUyOA==/tiny/Envoy-Medical-Inc.png?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://ml.globenewswire.com/media/YzBmOGE3OGQtNDBmOC00OWY0LWE1MWQtMTc5NGFlMGI4Y2JhLTUwMDExOTUyOA==/tiny/Envoy-Medical-Inc.png"/></p>

COCH

<p>Envoy Medical, Inc.（纳斯达克代码：COCH）宣布在《耳科学与神经耳科学》期刊上发表了一篇经过同行评审的文章，详细介绍了其全植入式 Acclaim®人工耳蜗的早期经验。研究强调了潜在的好处，包括患者的持续使用和生活质量的改善。Acclaim CI 旨在用于重度至极重度感音神经性听力损失，利用耳朵的自然解剖结构进行声音捕捉。该设备于 2019 年获得 FDA 突破性医疗器械认证，目前仍处于研究阶段。首席执行官 Brent Lucas 对参与者表示感谢，并对未来的试验充满乐观</p>

<p>11/12/2024 - 09:25 AM</p>
<div class="lb-trans"><p>2024 年 11 月 12 日- 上午 09:25</p>
</div><p><em>Study in Otology &amp; Neurotology outlines early experiences and potential benefits of breakthrough fully implanted cochlear implant</em></p>
<div class="lb-trans"><p><em>耳科学与神经耳科学研究概述了突破性全植入式人工耳蜗的早期经验和潜在好处</em></p>
</div><p><em>WHITE BEAR LAKE, Minnesota , Nov. 12, 2024 (GLOBE NEWSWIRE) --</em> Envoy Medical®, Inc. (“Envoy Medical”) (NASDAQ: “COCH”), a hearing health company focused on fully implanted hearing systems, today announces a peer-reviewed publication in <em>Otology &amp; Neurotology</em>, discussing early experiences with and highlighting potential benefits of the Company’s investigational fully implanted Acclaim <strong>®</strong> Cochlear Implant (Acclaim CI). The paper, titled, “Early Hearing Outcomes and Audiological Experiences with a Novel Fully Implanted Cochlear Implant,” discusses the initial results from a first-in-human, early feasibility study. The study had only been active for six months at the time these data being reported were collected and analyzed. All three patients are now approaching two years with their implants.</p>
<div class="lb-trans"><p><em>明尼苏达州白熊湖，2024 年 11 月 12 日（全球新闻稿）--</em> Envoy Medical®, Inc.（“Envoy Medical”）（纳斯达克：“COCH”），一家专注于全植入式听力系统的听力健康公司，今天宣布在_耳科学与神经耳科学_上发表了一篇经过同行评审的论文，讨论了与公司正在研究的全植入式 Acclaim <strong>®</strong> 人工耳蜗（Acclaim CI）的早期经验，并强调其潜在好处。该论文标题为 “新型全植入式人工耳蜗的早期听力结果和听力学经验”，讨论了一项首次在人类中进行的早期可行性研究的初步结果。该研究在收集和分析这些数据时仅进行了六个月。所有三名患者目前都已植入近两年。</p>
</div><p>“This publication begins to point out potential real-world benefits of a fully implanted cochlear implant. Hearing loss is with you all day – you cannot take off or shut off your hearing loss – so the potential benefit of a fully implanted hearing solution that allows access to sound throughout the day is exciting to think about for many patients. We are grateful for the three patients who participated to help us study this breakthrough device. We have learned a great deal and look forward to applying those learnings to a larger group of patients in our pivotal clinical trial, which we recently received FDA’s approval to begin,” said Brent Lucas, Envoy Medical CEO.</p>
<div class="lb-trans"><p>“这篇出版物开始指出全植入式人工耳蜗的潜在现实世界好处。听力损失伴随你一整天——你无法摘掉或关闭你的听力损失——因此，能够在一天中随时接触声音的全植入式听力解决方案的潜在好处让许多患者感到兴奋。我们对参与研究这一突破性设备的三名患者表示感谢。我们学到了很多，并期待将这些经验应用于我们最近获得 FDA 批准开始的关键临床试验中的更大患者群体，” Envoy Medical 首席执行官 Brent Lucas 说道。</p>
</div><p>Key highlights included:</p>
<div class="lb-trans"><p>主要亮点包括：</p>
</div><ul>
<li>All recipients were regular users of their devices. One patient reported using their device continuously (day and night), which study authors believe may support improved speech and quality of life outcomes.</li>
<li>Two of the three patients report optimizing their hearing benefit by using a hearing aid in the same ear as the cochlear implant. This flexibility and optionality could be a real-life benefit to potential users. Acclaim CI is designed to use the ear to pick up sound, which enables an opportunity for devices such as hearing aids, earbuds, or other consumer electronics to be used in the implanted ear.</li>
<li>All reported between three and five days of use on one charge.</li>
<li>Authors noted the ability of the device to be used at night, which may offer patients a sense of security that they cannot have with partially implanted devices where the externals are removed at night.</li>
</ul>
<div class="lb-trans"><ul>
<li>所有接受者都是其设备的常规用户。一名患者报告称其设备持续使用（昼夜不息），研究作者认为这可能支持改善言语和生活质量的结果。</li>
<li>三名患者中有两名报告称通过在与人工耳蜗相同的耳朵中使用助听器来优化其听力收益。这种灵活性和选择性可能对潜在用户带来现实生活中的好处。Acclaim CI 设计为利用耳朵捕捉声音，这为助听器、耳塞或其他消费电子设备在植入耳中使用提供了机会。</li>
<li>所有患者报告在一次充电后使用时间在三到五天之间。</li>
<li>作者指出该设备可以在夜间使用，这可能为患者提供了一种安全感，而这种安全感是部分植入设备在夜间移除外部组件时无法提供的。</li>
</ul>
</div><p><strong>About the Fully Implanted Acclaim® Cochlear Implant</strong></p>
<div class="lb-trans"><p><strong>关于全植入式 Acclaim®人工耳蜗</strong></p>
</div><p>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.</p>
<div class="lb-trans"><p>我们相信全植入式 Acclaim 人工耳蜗（“Acclaim CI”）是首个此类听力设备。Envoy Medical 的全植入式技术包括一个传感器，旨在利用耳朵的自然解剖结构，而不是麦克风来捕捉声音。</p>
</div><p>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.</p>
<div class="lb-trans"><p>Acclaim CI 旨在解决严重到极重度的感音神经性听力损失，而这种损失无法通过助听器得到充分解决。Acclaim CI 预计将适用于被合格医生评估为合适候选人的成年人。</p>
</div><p>The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.</p>
<div class="lb-trans"><p>Acclaim 人工耳蜗于 2019 年获得美国食品和药物管理局（FDA）的突破性设备认证。</p>
</div><p><strong>CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.</strong></p>
<div class="lb-trans"><p><strong>警告 全植入式 Acclaim 人工耳蜗是一种研究性设备。根据联邦（或美国）法律，仅限于研究使用。</strong></p>
</div><p><strong>About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI)</strong></p>
<div class="lb-trans"><p><strong>关于 Esteem®全植入式主动中耳植入物（FI-AMEI）</strong></p>
</div><p>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.</p>
<div class="lb-trans"><p>Esteem 全植入式主动中耳植入物（FI-AMEI）是唯一获得 FDA 批准的全植入式 * 听力设备，适用于被诊断为中度至重度感音神经性听力损失的成年人，允许使用耳朵的自然解剖结构实现 24/7 的听力能力。Esteem FI-AMEI 听力植入物是隐形的，不需要外部佩戴的组件，也不需要在耳道中放置任何东西以使其正常工作。与助听器不同，你永远不需要佩戴或摘下它。你无法丢失它。你不需要清洁它。Esteem FI-AMEI 听力植入物提供真正的 24/7 听力。</p>
</div><p>*Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.</p>
<div class="lb-trans"><p>* 一旦激活，外部 Esteem FI-AMEI 个人编程器在日常使用中不再需要。</p>
</div><p>Important safety information for the Esteem FI-AMEI can be found at:https://www.envoymedical.com/safety-information.</p>
<div class="lb-trans"><p>有关 Esteem FI-AMEI 的重要安全信息，请访问：https://www.envoymedical.com/safety-information。</p>
</div><p><strong>Additional Information and Where to Find It</strong></p>
<div class="lb-trans"><p><strong>附加信息及获取途径</strong></p>
</div><p>Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC’s website atwww.sec.gov.</p>
<div class="lb-trans"><p>Envoy Medical 向 SEC 提交的文件副本可在 SEC 网站 www.sec.gov 免费获取。</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性声明</strong></p>
</div><p>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 Acclaim CI being the first to market fully implanted cochlear implant; the safety, performance, and market acceptance of the Acclaim CI; 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 Form10-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.</p>
<div class="lb-trans"><p>本新闻稿包含根据 1995 年美国私人证券诉讼改革法案的 “安全港” 条款定义的 “前瞻性声明”。前瞻性声明可以通过使用诸如 “估计”、“计划”、“项目”、“预测”、“打算”、“将”、“期望”、“预期”、“相信”、“寻求”、“目标” 或其他类似表达来识别，这些词预测或指示未来事件或趋势，或者不是历史事项的陈述，但缺乏这些词并不意味着该声明不是前瞻性的。这些声明可能包括但不限于关于 Envoy Medical 对其业务前景、生产力、未来运营改进和资本投资计划及目标的期望；Acclaim CI 作为市场上首个完全植入的人工耳蜗；Acclaim CI 的安全性、性能和市场接受度；以及关于 Envoy Medical 可能或假定的未来运营的任何信息。本新闻稿中包含的前瞻性声明反映了 Envoy Medical 对未来事件的当前看法，并受到众多已知和未知风险、不确定性、假设和情况变化的影响，这些因素可能导致其实际结果与任何前瞻性声明中表达的结果显著不同。Envoy Medical 不保证所描述的事件会如所述发生（或会发生）。这些前瞻性声明面临许多风险和不确定性，包括但不限于 Envoy Medical A 类普通股的市场价格变化；Envoy Medical 股票在任何指数中的纳入变化或移除；Envoy Medical 在保留或招聘其高管、关键员工或董事方面的成功，或所需的变更；医疗器械行业的不可预测性、批准医疗器械的监管过程以及 Envoy Medical 产品的临床开发过程；医疗器械行业的竞争，以及未能及时以具有竞争力的价格推出新产品和服务以成功与竞争对手竞争；与 Envoy Medical 供应商的关系中断，或 Envoy Medical 自身在其产品的一些关键组件和材料的生产能力中断；资本需求的变化及融资和资本的可用性变化；利率或通货膨胀率的变化；法律、监管和其他诉讼可能会耗费高昂的成本和时间进行辩护；适用法律或法规的变化，或其在 Envoy Medical 上的适用；Envoy Medical 任何关键知识产权的丧失或未能充分保护知识产权；灾难性事件的影响，包括战争、恐怖主义和其他国际冲突；以及 Envoy Medical 在 2024 年 4 月 1 日提交的 10-K 表格年报中 “风险因素” 和 “关于前瞻性声明的警示说明” 部分中列出的其他风险和不确定性。如果这些风险中的任何一个实现，或 Envoy Medical 的假设被证明不正确，实际结果可能与这些前瞻性声明所暗示的结果有重大差异。虽然前瞻性声明反映了 Envoy Medical 的善意信念，但它们并不是未来表现的保证。Envoy Medical 不承担任何公开更新或修订任何前瞻性声明的义务，以反映基础假设或因素、新信息、数据或方法、未来事件或本新闻稿日期后的其他变化，除非适用法律要求。您不应对任何前瞻性声明过度依赖，这些声明仅基于 Envoy Medical 当前可用的信息。</p>
</div><h3></h3>
<div class="lb-trans"><h3></h3>
</div><p><strong>Investor Contact:</strong></p>
<div class="lb-trans"><p><strong>投资者联系：</strong></p>
</div><p>CORE IR</p>
<div class="lb-trans"><p>CORE IR</p>
</div><p>516-222-2560</p>
<div class="lb-trans"><p>516-222-2560</p>
</div><p>investorrelations@envoymedical.com</p>
<div class="lb-trans"><p>investorrelations@envoymedical.com</p>
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Envoy Medical 的完全植入式 Acclaim®人工耳蜗在同行评审的出版物中被重点介绍 | COCH 股票新闻