Identity
- Trade Name
- Neuro Cochlear Implant System FDA PMA
- Generic Name
- Implant, cochlear FDA PMA
Identifiers
- PMA Number
- P200021 FDA PMA
- FDA Product Code
- MCM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Ear, Nose, Throat FDA PMA
- FDA Decision
- APWD FDA PMA
The Neuro Cochlear Implant System is a Class III implant, cochlear, designed for individuals aged 18 and older with bilateral severe-to-profound sensorineural hearing loss. It is intended for patients who derive limited benefit from appropriately fitted hearing aids, as defined by a pure-tone average of 70 dB HL or greater at 500, 1000, and 2000 Hz, and scores of 50% or less on the Hearing in Noise Test (HINT).
This device is supplied as a reusable implantable system, with multiple model-specific components listed under registration numbers (e.g., 8043792, 1721676). It is approved under FDA PMA (P200021) and falls under the product code MCM. The system requires surgical implantation and is intended for use in clinical settings by qualified healthcare professionals. Sterility and handling instructions are manufacturer-specific and must be followed as per accompanying documentation.
Frequently asked questions
What patient criteria determine eligibility for the Neuro Cochlear Implant System?
Eligibility is based on age and hearing loss severity. The system is approved for adults aged 18 and older with bilateral severe-to-profound sensorineural hearing loss, defined by a pure-tone average of 70 dB HL or greater at 500, 1000, and 2000 Hz. Additionally, patients must derive limited benefit from hearing aids, demonstrated by scores of 50% or less on the Hearing in Noise Test (HINT). A three-month hearing aid trial is recommended for candidates not already fitted with hearing aids.
Is the Neuro Cochlear Implant System reusable or single-use, and how is it supplied?
The Neuro Cochlear Implant System is designed as a reusable implantable device. It is supplied as a complete system with multiple model-specific components, each identified by unique registration numbers (e.g., 8043792, 1721676). The system requires surgical implantation and is intended for use in clinical settings by qualified healthcare professionals.
What regulatory pathway was followed for FDA approval of the Neuro Cochlear Implant System?
The Neuro Cochlear Implant System received FDA approval through the Premarket Approval (PMA) process, with the PMA number listed as P200021. This pathway is used for Class III devices, which are typically higher-risk medical products requiring substantial evidence of safety and effectiveness. The system falls under product code MCM and was reviewed by the Ear, Nose, and Throat (EN) advisory committee.
Are there specific handling or sterility requirements for the Neuro Cochlear Implant System?
Sterility and handling instructions for the Neuro Cochlear Implant System are manufacturer-specific and must be strictly followed as outlined in the accompanying documentation provided by Oticon Medical. Since it is a reusable implantable device, proper sterilization protocols are critical to ensure safety and functionality before and after surgical use.
What are the key differences between the Neuro Cochlear Implant System and traditional hearing aids?
The Neuro Cochlear Implant System is intended for individuals who experience severe-to-profound hearing loss and gain limited benefit from hearing aids, unlike traditional hearing aids which amplify sound for milder hearing impairments. This implant bypasses damaged parts of the ear, directly stimulating the auditory nerve to provide sound perception. It requires surgical implantation and is not a wearable device like 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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P200021 | Class III | Active |
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Manufacturer
- Manufacturer
- Oticon Medical
Sources (1)
- FDA PMA P200021 24 fields · synced Oct 6, 2026