Core Points - The Hearing Device Coverage Clarification Act has been reintroduced in both the U.S. House and Senate to clarify that certain hearing implants are considered prosthetics, potentially allowing for Medicare coverage [1][2][4] - The House version of the bill, H.R. 1921, was reintroduced by Representatives Michelle Fischbach and Angie Craig, while the Senate version, S. 983, was reintroduced by Senators Amy Klobuchar and James Lankford, with expectations of bipartisan support [3] - The Act aims to provide Medicare coverage for fully implanted active middle ear hearing devices, distinguishing them from traditional hearing aids, which could benefit companies like Envoy Medical that produce such devices [4][5] Company Insights - Envoy Medical, a company specializing in fully implanted hearing systems, has received FDA PMA approval for its Esteem® device since 2010 and is one of the few companies with a fully implanted active middle ear implant [5][6] - The company believes that the passage of the Hearing Device Coverage Clarification Act would create more well-paying jobs in the U.S. and enhance competitiveness in the hearing implant industry, which is currently dominated by foreign players [5][6] - Envoy Medical's Acclaim Cochlear Implant is designed for severe to profound sensorineural hearing loss and received Breakthrough Device Designation from the FDA in 2019, indicating its innovative nature [6][8]

Core Insights - Envoy Medical has secured $10 million in funding from its largest shareholder, billionaire Glen Taylor, to support its pivotal clinical trial for the Acclaim cochlear implant and other operations [1][2] - The company is optimistic about the enrollment progress in its clinical trial, with significant interest reported from investigational sites [2] Funding Details - The $10 million financing is structured as an unsecured loan with a five-year term, deferring interest for the first two years and bearing an 8% interest rate [2] - Funds will be available as needed to maintain the company's operational momentum during a transformative year [1][2] Product Overview - The Acclaim cochlear implant is a first-of-its-kind fully implanted hearing device designed to address severe to profound sensorineural hearing loss [3][4] - The device leverages the natural anatomy of the ear to capture sound, distinguishing it from traditional hearing aids [3] Regulatory Status - The Acclaim cochlear implant received Breakthrough Device Designation from the U.S. FDA in 2019, indicating its potential to offer significant benefits over existing treatments [4]

Company Overview - Envoy Medical, Inc. is a hearing health company focused on fully implanted hearing devices, participating in the 37th Annual ROTH Conference from March 16-18, 2025 [1][2] Product Information - The Acclaim Cochlear Implant (Acclaim CI) is a first-of-its-kind fully implanted hearing device that utilizes a sensor to capture sound by leveraging the natural anatomy of the ear, rather than using a microphone [3] - The Acclaim CI is designed for adults with severe to profound sensorineural hearing loss, which is not adequately addressed by traditional hearing aids, and received Breakthrough Device Designation from the FDA in 2019 [4] - The Esteem Fully Implanted Active Middle Ear Implant (FI-AMEI) is the only FDA-approved fully implanted hearing device for adults with moderate to severe sensorineural hearing loss, providing 24/7 hearing capability without external components [5][6] Conference Participation - The CEO and CFO of Envoy Medical will hold one-on-one meetings with investors and analysts at the ROTH Conference to discuss recent events and provide updates [2]

Core Viewpoint - Envoy Medical has secured additional patents for its innovative cochlear implant technologies, enhancing its intellectual property portfolio and positioning in the hearing health market [1][2][4]. Patent Developments - The US Patent & Trademark Office issued US Pat. No. 12,214,195 on February 4, 2025, for an Implantable Cochlear System with Inner Ear Sensor, which includes a cochlear electrode, stimulator, inner ear sensor, and signal processor [2]. - US Pat. No. 12,233,256 will be issued on February 25, 2025, focusing on adjustable stereo cochlear implant systems that allow for independent volume adjustments for each subsystem [3]. - The Japanese Patent Office granted three new patents on December 2 and 3, 2024, related to cochlear implant subsystems and lead characterization, all under the title Implantable Cochlear System with Integrated Components and Lead Characterization [4]. - The Hong Kong Patent Office granted HK Patent No. HK40097814 on January 3, 2025, for Programming of Cochlear Implant Accessories, facilitating easier pairing of accessory devices to cochlear implant systems [5]. Product Overview - The Acclaim Cochlear Implant is highlighted as a first-of-its-kind fully implanted device designed to address severe to profound sensorineural hearing loss, leveraging the natural anatomy of the ear for sound capture [6][7]. - The Acclaim CI received Breakthrough Device Designation from the FDA in 2019, indicating its potential significance in the market [8].

Core Viewpoint - Envoy Medical has selected seven investigational sites for its pivotal clinical trial of the Acclaim® cochlear implant, with initial patient enrollment expected in Q1 2025 [2][3]. Company Overview - Envoy Medical, Inc. is a hearing health company focused on developing innovative solutions for hearing loss, specifically through its fully implanted Acclaim® cochlear implant [2][3]. Clinical Trial Details - The Investigational Device Exemption (IDE) for the Acclaim® cochlear implant study was approved by the FDA, which previously granted it Breakthrough Device Designation [3][10]. - The Acclaim CI is designed to be fully implanted without external components, utilizing the ear's natural anatomy for sound capture, allowing for all-day hearing with a multi-day rechargeable battery [3][9][10]. - The trial will involve seven cochlear implant centers, each with trained surgeons and audiologists dedicated to the study [5][6]. Study Sites - The selected investigational sites include: - Mayo Clinic, Rochester, Minnesota - Medical University of South Carolina, Charleston, South Carolina - University of Florida Health, Gainesville, Florida - Shohet Ear Associates, Seal Beach, California - Hearts for Hearing, Oklahoma City, Oklahoma - Center for Neurosciences, Tucson, Arizona - Cleveland Clinic Foundation, Cleveland, Ohio [6][7][8]. Product Differentiation - The Acclaim CI is positioned as a first-of-its-kind device aimed at addressing severe to profound sensorineural hearing loss, which is not sufficiently managed by traditional hearing aids [9][10].

Core Viewpoint - Envoy Medical, Inc. has announced the issuance of four new patents related to innovative hearing solutions, emphasizing its commitment to advancing technology in the hearing health industry [1][2][3][4][5]. Patent Announcements - The US Patent & Trademark Office issued US Patent No. 12,151,102 for a Combination Hearing Aid and Cochlear Implant System, focusing on updating transfer functions in cochlear implants to accommodate external hearing aids [2]. - The European Patent Office will grant European Patent No. 4255554, also for a Combination Hearing Aid and Cochlear Implant System, which includes a status indicator for external auditory devices [3]. - European Patent No. 4255555 will be granted for Cochlear Implant Stimulation Calibration, which involves calibrating current flow in cochlear implant systems [4]. - European Patent No. 4319866 will be granted for Cochlear Implant System with Electrode Impedance Diagnostics, allowing for the determination of impedance and stimulation parameters in cochlear implants [5]. Product Innovations - The Acclaim Cochlear Implant is highlighted as a first-of-its-kind fully implanted device designed to address severe to profound sensorineural hearing loss, leveraging the natural anatomy of the ear [6][7]. - The Acclaim CI received Breakthrough Device Designation from the FDA in 2019, indicating its potential significance in the market [7]. - The Esteem Fully Implanted Active Middle Ear Implant (FI-AMEI) is noted as the only FDA-approved fully implanted hearing device for adults with moderate to severe sensorineural hearing loss, providing continuous hearing without external components [9].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number - 001-40133 ENVOY MEDICAL, INC. | --- | --- | |----------------------------------------------------------------------------|--------------- ...

Exhibit 99.1 Envoy Medical Reports Third Quarter 2024 Results and Other Exciting Events FDA approval to begin pivotal trial of fully implanted cochlear implant and AMA approval of CPT codes for the Company's already FDA-approved fully implanted middle ear implant are two of the exciting developments for the growing company WHITE BEAR LAKE, Minn., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Envoy Medical®, Inc. ("Envoy Medical") (Nasdaq: COCH), a revolutionary hearing health company focused on fully implanted hearing ...

The Acclaim® Fully Implanted Cochlear Implant is differentiated from existing cochlear implants and may offer new option for hearing loss patients WHITE BEAR LAKE, Minnesota, Nov. 01, 2024 (GLOBE NEWSWIRE) --  Envoy Medical®, Inc. (“Envoy Medical”) (NASDAQ: “COCH”), a hearing health company focused on fully implanted hearing systems, today announces that its Investigational Device Exemption (IDE) application for its pivotal study of the Acclaim® Fully Implanted Cochlear Implant has been approved by the U.S ...

Core Viewpoint - Envoy Medical, Inc. is set to present a corporate overview at the LD Micro Main Event XVII, highlighting its focus on fully implanted hearing systems and innovative products in the hearing health sector [1][2]. Company Overview - Envoy Medical specializes in hearing health, particularly in fully implanted hearing systems, with products like the Esteem fully implanted active middle ear implant (FI-AMEI) and the Acclaim Cochlear Implant [1][5]. - The Esteem FI-AMEI is the only FDA-approved fully implanted hearing device for adults with moderate to severe sensorineural hearing loss, providing continuous hearing without the need for external components [3]. - The Acclaim Cochlear Implant is an investigational device designed for severe to profound sensorineural hearing loss, leveraging the ear's natural anatomy for sound capture [5]. Product Details - The Esteem FI-AMEI offers 24/7 hearing capability, is invisible, and does not require external components or cleaning, distinguishing it from traditional hearing aids [3]. - The Acclaim Cochlear Implant received Breakthrough Device Designation from the FDA in 2019, marking it as a significant advancement in hearing technology [5]. Event Information - David R. Wells, the Chief Financial Officer, will present on October 29, 2024, at 12:00 PM Pacific Time, and will be available for one-on-one meetings with registered investors [2][3].