3m Brand Cochlear Implant System/House Design
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- 3M BRAND COCHLEAR IMPLANT SYSTEM/HOUSE DESIGN FDA PMA
- Generic Name
- Implant, cochlear FDA PMA
Identifiers
- PMA Number
- P830069 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
- S001 FDA PMA
This device is a Cochlear Implant, classified under the nomenclature authority as an implantable electronic device designed to restore hearing function in individuals with severe to profound sensorineural hearing loss. It consists of an internal component surgically implanted in the cochlea and an external speech processor that transmits sound signals to stimulate the auditory nerve, enabling auditory perception.
The Cochlear Implant System/House Design is intended for use in clinical settings by qualified healthcare professionals, including otolaryngologists and audiologists. It is supplied as a reusable system with sterile components for surgical implantation, adhering to FDA_PMA authorization (PMA Number: P830069). The device is not MRI-safe and requires proper handling and storage as per manufacturer guidelines to maintain functionality and sterility.
Frequently asked questions
What is the primary purpose of the 3M Brand Cochlear Implant System/House Design and who should use it?
The 3M Brand Cochlear Implant System/House Design is designed to restore hearing function in individuals with severe to profound sensorineural hearing loss by stimulating the auditory nerve. It is intended for use in clinical settings by qualified healthcare professionals, such as otolaryngologists and audiologists, who specialize in ear, nose, and throat (ENT) care.
Is the Cochlear Implant System reusable or single-use, and how are the sterile components handled?
The Cochlear Implant System is supplied as a reusable system, but it includes sterile components specifically for surgical implantation. These sterile components must be handled according to manufacturer guidelines to ensure proper sterility and functionality during use.
Can this device be used in an MRI environment, and what special considerations should be taken during storage?
No, the Cochlear Implant System is **not** MRI-safe. Proper handling and storage are critical to maintain its functionality and sterility, as outlined in the manufacturer’s guidelines. Avoid exposure to magnetic fields and follow storage instructions to preserve device integrity.
What regulatory pathway was followed for this device’s approval, and what does that mean for clinicians?
The device was authorized through the FDA’s **Premarket Approval (PMA)** process (PMA Number: P830069), which is the highest level of regulatory review for Class III medical devices. This means it underwent rigorous clinical evaluation to demonstrate safety and effectiveness before approval, ensuring clinicians can rely on its proven performance for cochlear implantation.
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 | P830069 | Class III | Active |
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Manufacturer
- Manufacturer
- Cochlear Americas
Sources (1)
- FDA PMA P830069 24 fields · synced Sep 18, 2026