Nucleus 22 Cochlear Implant System for Adults/Esprit 22
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI FDA PMA
- Generic Name
- Implant, cochlear FDA PMA
Identifiers
- PMA Number
- P840024 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
- PMA Supplement
- S002 FDA PMA
The Nucleus 22 Cochlear Implant System for Adults/Esprit 22 is an implantable hearing prosthesis classified as a cochlear implant under the generic name 'Implant, cochlear'. It is designed to provide auditory perception for individuals with severe to profound sensorineural hearing loss.
This system is supplied as an implantable device intended for surgical placement in the cochlea. It is a reusable implant system requiring sterile handling during implantation and is authorized for use under FDA Premarket Approval (PMA) number P840024. The device is manufactured by Cochlear Americas and registered under multiple facility identifiers.
Frequently asked questions
What is the regulatory authorization for the Nucleus 22 Cochlear Implant System?
The Nucleus 22 Cochlear Implant System for Adults/Esprit 22 is authorized under FDA Premarket Approval (PMA) with PMA number P840024, as indicated in the AUTHORIZATIONS field as FDA_PMA and confirmed by the pma_number field.
Who manufactures the Nucleus 22 Cochlear Implant System?
The Nucleus 22 Cochlear Implant System for Adults/Esprit 22 is manufactured by Cochlear Americas, as stated in both the MANUFACTURER and applicant fields within the device data.
What is the generic name and device class of the Nucleus 22 Cochlear Implant System?
The generic name of the device is 'Implant, cochlear' and it is classified as a Class III medical device, as specified in the openfda field under device_class=3 and device_name=Implant, Cochlear.
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 | P840024 | Class III | Active |
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Manufacturer
- Manufacturer
- Cochlear Americas
Sources (1)
- FDA PMA P840024 24 fields · synced Sep 18, 2026