Nucleus 24 Auditory Brainstem Implant System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM FDA PMA
- Generic Name
- Implant, auditory brainstem FDA PMA
Identifiers
- PMA Number
- P000015 FDA PMA
- FDA Product Code
- MHE FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Ear, Nose, Throat FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Nucleus 24 Auditory Brainstem Implant System is an Implant, Auditory Brainstem, designed to restore useful hearing through electrical stimulation of the cochlear nucleus. It is intended for individuals aged 12 years or older diagnosed with Neurofibromatosis Type 2 (NF2), including those undergoing tumor removal or with previously excised bilateral acoustic tumors.
This device is implanted during surgical procedures for tumor excision and electrode placement, eliminating residual hearing. It is supplied as a Class III medical device with FDA_PMA approval (PMA Number: P000015) and requires appropriate preoperative counseling regarding expectations and postoperative rehabilitation. The system is not single-use and must be handled under sterile conditions during implantation.
Frequently asked questions
Who is the Nucleus 24 Auditory Brainstem Implant System intended for, and what conditions qualify a patient for this device?
The Nucleus 24 Auditory Brainstem Implant System is specifically designed for individuals aged 12 years or older who have been diagnosed with Neurofibromatosis Type 2 (NF2). This includes patients undergoing tumor removal for NF2, whether during the first or second-side excision, or those who have already had bilateral acoustic tumors removed. The device is not intended for general hearing loss but rather for restoring useful hearing through electrical stimulation of the cochlear nucleus in patients with NF2-related hearing loss.
Is the Nucleus 24 Auditory Brainstem Implant System single-use or reusable, and how should it be handled during implantation?
The Nucleus 24 Auditory Brainstem Implant System is not single-use and is intended for reuse in appropriate clinical settings. However, it must be handled under sterile conditions during the implantation procedure to ensure patient safety and device integrity, as it is a Class III medical device.
What kind of preoperative counseling is required before a patient receives the Nucleus 24 Auditory Brainstem Implant System?
Preoperative counseling is mandatory and should include clear communication about the potential benefits of the device, as well as realistic expectations regarding outcomes. Patients and their families must be highly motivated to participate in postoperative rehabilitation, as this is critical to achieving the best possible results with the Nucleus 24 Auditory Brainstem Implant System.
What regulatory approval does the Nucleus 24 Auditory Brainstem Implant System hold, and how was this approval determined?
The Nucleus 24 Auditory Brainstem Implant System holds FDA Pre-Market Approval (PMA) with the approval number P000015. This approval was granted after a review by the FDA’s Ear, Nose, and Throat (EN) advisory committee, which evaluated the device’s safety and effectiveness for its intended use in individuals aged 12 and older with Neurofibromatosis Type 2 (NF2). The approval process included an expedited review.
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 | P000015 | Class III | Active |
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Manufacturer
- Manufacturer
- Cochlear Americas
Sources (1)
- FDA PMA P000015 24 fields · synced Sep 18, 2026