Identity
- Trade Name
- CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT FDA PMA
- Generic Name
- Implant, cochlear FDA PMA
Identifiers
- PMA Number
- P940022 FDA PMA
- FDA Product Code
- MCM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Ear, Nose, Throat FDA PMA
- FDA Decision
- APCB FDA PMA
The Clarion Multi-Strategy Cochlear Implant Version 1.2 is a Class III medical device classified as an implant, cochlear. This device is designed to restore hearing in adult patients with severe to profound sensorineural hearing loss by electrically stimulating the auditory nerve via electrodes implanted in the cochlea, enabling auditory perception through a sound processor and internal receiver-stimulator components.
The device is supplied as a reusable internal implant system, requiring surgical implantation by a qualified otolaryngologist or audiologist. It is intended for use in an adult population and has received FDA approval under PMA number P940022. The system includes multiple electrode array sizes and configurations, with each model number uniquely identifying specific components or versions. Sterility and handling instructions are provided by the manufacturer to ensure proper surgical and post-operative care.
Frequently asked questions
What is the primary purpose of the Clarion Multi-Strategy Cochlear Implant Version 1.2 and who is it designed for?
The Clarion Multi-Strategy Cochlear Implant Version 1.2 is designed to restore hearing in adult patients with severe to profound sensorineural hearing loss. It achieves this by electrically stimulating the auditory nerve through electrodes implanted in the cochlea, allowing auditory perception via an internal receiver-stimulator and external sound processor. The device is explicitly authorized for use in adults only, as indicated by its FDA approval under PMA number P940022.
How is the Clarion Multi-Strategy Cochlear Implant Version 1.2 supplied, and what does the surgical process involve?
The device is supplied as a reusable internal implant system, meaning the electrodes and internal components are intended for surgical implantation by a qualified otolaryngologist or audiologist. The system includes multiple electrode array sizes and configurations, each uniquely identified by model numbers. The device is not pre-sterilized for single-use; instead, sterility and handling instructions are provided by the manufacturer to ensure proper surgical and post-operative care.
Are there different sizes or models available for the Clarion Multi-Strategy Cochlear Implant Version 1.2, and how are they identified?
Yes, the Clarion Multi-Strategy Cochlear Implant Version 1.2 offers multiple electrode array sizes and configurations. Each model is uniquely identified by a specific model number, which helps distinguish between different versions or components within the system. These variations allow for customization based on patient anatomy and clinical needs.
What regulatory pathway was followed for FDA approval of this device, and what does that mean for its use?
The Clarion Multi-Strategy Cochlear Implant Version 1.2 received FDA approval through the Premarket Approval (PMA) process, indicated by PMA number P940022. This pathway is typically used for high-risk medical devices like cochlear implants, ensuring rigorous evaluation of safety and effectiveness before approval. The approval specifically authorizes its use in an adult population with severe to profound sensorineural hearing loss, as outlined in the authorization details.
How should the Clarion Multi-Strategy Cochlear Implant Version 1.2 be stored before and after surgical use?
The device is not pre-sterilized for single-use, so storage before surgical use must adhere to manufacturer-provided sterility and handling instructions to maintain its integrity. After surgical use, the reusable internal components require proper cleaning, sterilization, and storage as directed by the manufacturer to ensure they remain safe and functional for subsequent procedures. These protocols are critical to prevent contamination and maintain device performance.
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 | P940022 | N/A | Active |
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Manufacturer
- Manufacturer
- Advanced Bionics Corp.
Sources (1)
- FDA PMA P940022 24 fields · synced Sep 18, 2026