Summary: Envoy Medical has chosen seven investigational sites for its pivotal clinical trial of the fully implanted Acclaim cochlear implant, with initial patient enrollment set to begin in Q1 2025.

Takeaways:

  1. FDA-Approved Trial: The U.S. FDA granted Investigational Device Exemption (IDE) approval for the pivotal study of the Acclaim CI in November 2024, following its earlier Breakthrough Device Designation.
  2. Innovative Design: Unlike traditional cochlear implants, the Acclaim CI is fully implanted, uses the ear’s natural anatomy to detect sound, and allows for all-day hearing with a rechargeable battery lasting multiple days.
  3. Leading Study Sites: Seven top cochlear implant centers, with experienced surgeons and audiologists, have been selected to participate in the trial, reinforcing the significance of this groundbreaking hearing technology.

Envoy Medical, a hearing health company, has selected seven study sites for participation in its pivotal clinical trial to investigate its fully implanted Acclaim cochlear implant (Acclaim CI). Initial patient enrollment will begin during the first quarter of 2025.

The Investigational Device Exemption (IDE) application for the pivotal study of the Acclaim Fully Implanted Cochlear Implant was approved by the U.S. Food and Drug Administration (FDA) in November 2024. The Acclaim CI is a fully implanted cochlear implant that previously received Breakthrough Device Designation from the FDA. 

According to Envoy Medical, it is currently differentiated from other cochlear implants in that it is designed to:  

  • be fully implanted with no external components attached to the side of the head
  • leverage the natural anatomy of the ear to pick up sound rather than rely on an external or sub-dermal microphone
  • allow for all day hearing
  • have a battery lasting multiple days between recharge.

Preparing the Clinical Trial

Envoy Medical is working closely with each investigational site through site initiation documents and logistics. First patients will begin to be screened and enrolled after Institutional Review Boards (IRBs) have completed their review. Additional study-specific updates can be found on ClinicalTrials.gov, by directly contacting the study sites listed below, or by contacting Envoy Medical.

“We are thrilled to announce the selection of these seven cochlear implant centers for participation in our pivotal clinical trial to study the safety and effectiveness of our breakthrough fully implanted cochlear implant,” says Brent Lucas, CEO of Envoy Medical, “Involvement of these highly-respected cochlear implant centers in our trial is, in my opinion, further validation that we have something exciting and potentially game changing in the fully implanted Acclaim cochlear implant.”

Dedication to Cochlear Implants

Each study site has a dedicated cochlear implant surgeon and up to two cochlear implant audiologists who have already undergone or are scheduled to complete product-specific training on the Acclaim cochlear implant. These individuals have dedicated their professional lives to helping those who suffer from significant hearing loss.

“These are people at the top of their game,” says Lucas, “We are incredibly humbled by the opportunity to work with them.”