Acclaim® Cochlear Implant

Envoy Medical is developing and has recently received FDA review to begin a pivotal clinical study for a new first-of-it's kind, fully implanted cochlear implant, the Acclaim Cochlear Implant.

If approved by the Food and Drug Administration (FDA), it may lead to a shift from partially implanted cochlear implants to fully implanted cochlear implants.

CAUTION: Investigational device. Limited by federal (or United States) law to investigational use.

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The Acclaim Cochlear Implant

Our novel implanted piezoelectric sensor uses the ear’s natural anatomy to capture sound as it enters the outer and middle ear.  Sound is therefore not artificially distorted as is common with external microphone technology found in currently available traditional hearing devices such as hearing aids and cochlear implants.

Sounds gathered by the sensor are sent to the processor, where they are converted into customized electronic signals that activate the implanted electrode array and subsequently the cochlea and hearing nerve, ultimately sending sounds to the brain.

NOTE: Video is silent 

Animation is for illustrative purposes only. May not be indicative of individual characteristics, placement, or use.

  • Designed to function in environments not ideally suited for external components.
  • Designed to alleviate the burden and discomfort of wearing external components all waking hours.
  • Designed to use an implanted rechargeable battery intended to last several days between charges.
  • Designed without an external artificial microphone. The device is intended to allow the ear's natural anatomy to pick up sounds similar to the way nature intended.

   

Fully Implanted Cochlear Implant Trial Patient (Michael) - Envoy Medical

For captions please click CC on the menu bar.

CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use.

Michael is a patient in the Early Feasibility Trial for the fully implanted Acclaim® cochlear implant by Envoy Medical (www.envoymedical.com). In this video, recorded as part of the investigational early feasibility clinical trial's protocol, he shares some of his experiences with the intent and understanding that it will be shared publicly.

The information presented or discussed is for general educational purposes only and may not be representative of all or typical patient outcomes. It is not intended to be a substitute for professional medical advice and should not be interpreted to contain diagnostic or treatment recommendations. Each person’s situation is unique, and risks, outcomes, experiences, and results may vary. You should talk to your healthcare professional about important safety information, risks, options, and what may be right for you.

These individuals received reimbursement from Envoy Medical for travel costs and received their device at no cost through participation in an early feasibility clinical study. They were not paid for sharing their experience.

CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use.

©2025 Envoy Medical. All rights reserved. Acclaim, Envoy, and Envoy Medical are registered trademarks of Envoy Medical Corporation.

FDA Breakthrough Device Designation Status

In March 2019, the Acclaim cochlear implant received the highly coveted  Breakthrough Device Designation status. In addition, the Acclaim cochlear implant was previously accepted into the FDA’s Center for Devices and Radiological Health Early Feasibility Study Program. 

CAUTION: Investigational device. Limited by federal (or United States) law to investigational use.