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# FDA OKs Envoy Medical Cochlear Implant Study
- URL: https://www.fdaweb.com/fda-oks-envoy-medical-cochlear-implant-study/
- Published: 2024-11-05T12:00:00.000Z
- Updated: 2026-09-14T14:46:13.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158129

FDA has approved an Envoy Medical IDE for its pivotal study of the Acclaim Fully Implanted Cochlear Implant, an implanted sensor that the company says is designed to leverage the natural anatomy of the ear to capture sound. The agency approved the IDE application as a staged clinical study, which “allows preliminary clinical data to be gathered on a subset of patients prior to expanding enrollment to the full subject cohort,” the company says.

Envoy says the device is also designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. It expects it will be indicated for adults who have been deemed adequate candidates by a qualified physician.

The Acclaim Cochlear Implant received a breakthrough device designation 2019.