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Nucleus Hybrid L24 Cochlear Implant System

FDA PMA

Class III (US FDA PMA)

PMA P130016

by Cochlear Americas

Identity

Trade Name
NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEM FDA PMA
Generic Name
Cochlear implant with combined electrical stimulation and acoustic amplification FDA PMA

Identifiers

PMA Number
P130016 FDA PMA
FDA Product Code
PGQ FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Ear, Nose, Throat FDA PMA
FDA Decision
APPR Approved FDA PMA

The Nucleus Hybrid L24 Cochlear Implant System is a Class III medical device classified as a cochlear implant with combined electrical stimulation and acoustic amplification. It is designed to provide electric stimulation to the mid-to-high frequency regions of the cochlea while delivering acoustic amplification to low-frequency regions, targeting patients with residual low-frequency hearing sensitivity and severe to profound high-frequency sensorineural hearing loss.

This system is intended for unilateral use in patients aged 18 years and older who derive limited benefit from appropriately fitted bilateral hearing aids. The device is supplied as a sterile, single-use implantable system, with associated components for surgical implantation and activation. It is regulated under FDA Premarket Approval (PMA) and includes multiple FEI numbers for tracking. The system requires professional fitting and programming by qualified audiologists or otolaryngologists in clinical settings.

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

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Cochlear Americas

Sources (1)

  • FDA PMA P130016 24 fields · synced Sep 18, 2026