Nucleus 22 Channel Cochlear Implant for Children
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYS /CHILDREN FDA PMA
- Generic Name
- Implant, cochlear FDA PMA
Identifiers
- PMA Number
- P890027 FDA PMA
- FDA Product Code
- MCM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Ear, Nose, Throat FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Nucleus 22 Channel Cochlear Implant for Children is an implantable cochlear implant system designed to provide hearing sensation to individuals with severe to profound sensorineural hearing loss. It consists of an internal receiver-stimulator with a 22-channel electrode array and an external speech processor that converts sound into electrical signals.
This device is surgically implanted and intended for use in pediatric patients. It is supplied as a sterile, single-use implant system and requires surgical implantation by a qualified otolaryngologist. The device is regulated under FDA PMA approval (P890027) and is not MRI safe without specific conditions; users must consult labeling for MRI compatibility guidelines.
Frequently asked questions
What is the Nucleus 22 Channel Cochlear Implant for Children used for?
The Nucleus 22 Channel Cochlear Implant for Children is used to provide hearing sensation to children with severe to profound sensorineural hearing loss who do not benefit from hearing aids. It functions by converting sound into electrical signals that stimulate the auditory nerve, enabling the perception of sound.
Is the Nucleus 22 Channel Cochlear Implant for Children MRI safe?
The device data does not state that the Nucleus 22 Channel Cochlear Implant for Children is MRI safe. MRI compatibility must be determined from the device’s specific labeling; users should consult the manufacturer’s guidelines before undergoing any MRI procedure.
What authorization does the Nucleus 22 Channel Cochlear Implant for Children have?
The Nucleus 22 Channel Cochlear Implant for Children has FDA PMA (Premarket Approval) authorization, as indicated by the PMA number P890027 in the device data. This signifies it underwent rigorous scientific review to ensure safety and effectiveness.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P890027 | Class III | Active |
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Manufacturer
- Manufacturer
- Cochlear Americas
Sources (1)
- FDA PMA P890027 24 fields · synced Sep 18, 2026