Identity
- Trade Name
- CLARION MULTI-STRATEGY COCHLEAR IMPLANT FDA PMA
- Generic Name
- Implant, cochlear FDA PMA
Identifiers
- PMA Number
- P960058 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 HiResolution Bionic Ear System is a cochlear implant intended to restore a level of auditory sensation to children with profound sensorineural deafness via electrical stimulation of the auditory nerve. It is indicated for children aged 2 through 17 years, with implantation possible as young as 18 months if ossification is present.
The device is supplied as an implantable system and is intended for use in clinical settings under professional supervision. It is a Class III medical device authorized under FDA PMA P960058 and is not described as sterile, single-use, or reusable in the provided data; no MRI safety, storage, or size specifications are included in the source material.
Frequently asked questions
What is the HiResolution Bionic Ear System intended to do?
The HiResolution Bionic Ear System is intended to restore a level of auditory sensation to children with profound sensorineural deafness by electrically stimulating the auditory nerve, as stated in the approval documentation for the Clarion Multi-Strategy Cochlear Implant.
Who is the HiResolution Bionic Ear System intended for?
The device is intended for children aged 2 through 17 years with profound bilateral sensorineural deafness who have lacked benefit from appropriately fitted hearing aids; children as young as 18 months may be implanted if X-rays show evidence of ossification.
What regulatory authorization does the HiResolution Bionic Ear System have?
The HiResolution Bionic Ear System has received FDA Premarket Approval (PMA) under application number P960058, as indicated in the AUTHORIZATIONS and PMA_NUMBER fields of the device data.
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 | P960058 | Class III | Active |
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Manufacturer
- Manufacturer
- Advanced Bionics
Sources (1)
- FDA PMA P960058 24 fields · synced Sep 18, 2026