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Envoy Medical's Acclaim Cochlear Implant Pivotal Study Receives FDA Approval

• Envoy Medical received FDA approval for its IDE application to begin a pivotal study of the Acclaim® Fully Implanted Cochlear Implant, a novel hearing solution. • The Acclaim® device uses an implanted sensor to capture sound, leveraging the ear's natural anatomy, differentiating it from existing cochlear implants. • The company plans to select top cochlear implant institutions in the U.S. as study sites and will share information as IRB approvals are obtained. • The Acclaim Cochlear Implant previously received Breakthrough Device Designation from the FDA in 2019, highlighting its potential impact.

Envoy Medical, Inc. (NASDAQ: COCH) has announced FDA approval of its Investigational Device Exemption (IDE) application for a pivotal study of the Acclaim® Fully Implanted Cochlear Implant. This approval marks a significant step toward offering a new treatment option for individuals with severe to profound hearing loss.

Acclaim® Cochlear Implant: A Novel Approach

The Acclaim® device distinguishes itself from traditional cochlear implants through its innovative design. Instead of relying on a microphone, it incorporates an implanted sensor that utilizes the natural anatomy of the ear to capture sound. This unique approach may provide a more discrete and natural hearing experience for patients.
Brent Lucas, CEO of Envoy Medical, stated that the company believes the differences in their device’s design provide an opportunity to pursue this important therapy in a more discrete manner and offer candidates a welcomed new option that may get more patients to embrace the potential benefits of a cochlear implant.

Clinical Study Details

Envoy Medical intends to collaborate with leading cochlear implant centers across the United States for the pivotal study. The company will release details about the investigational sites as Institutional Review Board (IRB) approvals are secured. The FDA has approved the IDE application as a staged clinical study, allowing preliminary data collection on a subset of patients before full cohort enrollment.

Addressing Unmet Needs in Hearing Loss

It is estimated that approximately 95% of patients with significant hearing loss who could benefit from a cochlear implant have not received one. The Acclaim® device aims to address this gap by offering a fully implanted option that may be more appealing to potential candidates.

Envoy Medical's Broader Portfolio

In addition to the Acclaim® Cochlear Implant, Envoy Medical offers the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI), an FDA-approved device for adults with moderate to severe sensorineural hearing loss. The Esteem® implant provides 24/7 hearing capability without external components.

Cautionary Note

The Acclaim® Cochlear Implant is currently an investigational device and is limited by federal law to investigational use.
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Reference News

[1]
Envoy Medical Receives FDA Approval To Initiate Pivotal - GlobeNewswire
globenewswire.com · Nov 1, 2024

Envoy Medical's Acclaim® Fully Implanted Cochlear Implant IDE application approved by FDA, offering a new option for hea...

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