Identity
- Trade Name
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM FDA PMA
- Generic Name
- Implant, cochlear FDA PMA
Identifiers
- PMA Number
- P970051 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 24 Cochlear Implant System is a cochlear implant, a type of implant designed to restore a level of auditory sensation to adults and children. It works by providing electrical stimulation of the auditory nerve. The system is designed to bypass damaged or non-functioning parts of the ear and directly stimulate the auditory nerve, allowing individuals to perceive sound. The Nucleus 24 Cochlear Implant System is classified as a class 3 device, indicating a high level of risk and requiring a premarket approval application.
The Nucleus 24 Cochlear Implant System is supplied by Cochlear Americas and has been authorized by the FDA via a premarket approval (PMA) application. The system is intended for use in individuals who are profoundly deaf or severely hard-of-hearing and who receive little to no benefit from traditional hearing aids. The device is designed for long-term use and is typically implanted surgically. The Nucleus 24 Cochlear Implant System has been assigned a product code of MCM and has been registered with the FDA.
Frequently asked questions
What is the Nucleus 24 Cochlear Implant System intended to do?
The Nucleus 24 Cochlear Implant System is intended to restore a level of auditory sensation to adults and children via electrical stimulation of the auditory nerve.
What type of device is the Nucleus 24 Cochlear Implant System?
The Nucleus 24 Cochlear Implant System is a class 3 cochlear implant, indicating a high level of risk and requiring a premarket approval application.
Who is the Nucleus 24 Cochlear Implant System intended for?
The Nucleus 24 Cochlear Implant System is intended for use in individuals who are profoundly deaf or severely hard-of-hearing and who receive little to no benefit from traditional hearing aids.
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. Sources consulted: Cochlear Nucleus® Hybrid™ Implant System : Product Guide, Cochlear® Nucleus® Hearing System, [PDF] Nucleus® 24 CI24M - Surgeon's Guide, Nucleus 24 Cochlear Implant System – P970051/S205 - FDA, The evolution of cochlear implant technology and its clinical ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P970051 | Class III | Active |
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Manufacturer
- Manufacturer
- Cochlear Americas
Sources (1)
- FDA PMA P970051 24 fields · synced Sep 18, 2026