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Powered Insertion System For A Cochlear Implant Electrode Array

FDA product code QQH · 1 cleared devices

Class 2 Ear, Nose, Throat
Regulation
21 CFR 874.4450
Review panel
EN
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2026-01-09 – 2026-01-09

A powered insertion system for a cochlear implant electrode array is a prescription device used to assist in placing an electrode array into the cochlea.

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