First Two Participants Successfully Enrolled In Pivotal Clinical Study For Breakthrough Fully Implanted Cochlear Implant

Envoy Medical®, Inc. (“Envoy Medical”) (NASDAQ: “COCH”), a hearing health company focused on fully implanted hearing systems, has announced that the first two participants have been successfully enrolled in the pivotal clinical study for its Acclaim® Fully Implanted Cochlear Implant (Acclaim CI). This breakthrough device is designed to address the hearing needs of adults diagnosed with severe to profound sensorineural hearing loss who have not benefited adequately from traditional hearing aids.

The Acclaim CI is an investigational device that leverages unique sensor technology from Envoy Medical's fully implanted Esteem active middle ear implant. Unlike existing cochlear implants, the Acclaim CI is designed without any externally worn components and uses the ear to pick up sound, making it a novel and innovative solution for hearing loss.

The pivotal clinical study, approved by the U.S. Food and Drug Administration (FDA), is expected to last 18 months and will be followed by a premarket approval (PMA) application to the FDA. The study aims to gather preliminary clinical data on a subset of patients before expanding enrollment to the full subject cohort.

Envoy Medical plans to select top cochlear implant institutions in the U.S. as investigational sites for the study. As Institutional Review Board (IRB) approvals are obtained, the company will share information on the investigational sites for interested patients.

The fully implanted design of the Acclaim CI addresses several challenges faced by current cochlear implant users, such as the need to remove external components at night or during physical activities. This design offers potential benefits such as always-on hearing, no risk of loss or damage, improved discretion, and enhanced comfort and convenience.

The global cochlear implants market is expected to grow at a CAGR of 7.6% from 2025 to 2034, driven by factors such as increasing prevalence of hearing loss and rising awareness and early diagnosis. The fully implanted cochlear implant market is expected to contribute to this growth, as it offers a new option for patients seeking a more discreet and convenient hearing solution.



In conclusion, the successful enrollment of the first two participants in the pivotal clinical study for the Acclaim® Fully Implanted Cochlear Implant marks a significant milestone in the development of this innovative hearing device. As the study progresses, Envoy Medical aims to gather data that will support the device's potential approval and commercialization, ultimately offering a new option for patients seeking a more discreet and convenient hearing solution.