This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Nucleus 24 Cochlear Implant System
PMA Applicant: Cochlear Americas
Address: 13059 East Peakview Avenue, Centennial, CO 80111
Approval Date: March 17, 2020
Approval Letter: Approval Order

What is it?
The Nucleus 24 Cochlear Implant System is an implant that provides the user with hearing sensation through electrical stimulation of the hearing nerve (auditory nerve).

The system consists of an internal and an external component.

The Nucleus 24 Cochlear Implant System was previously approved for use in patients ages 12 months and older. This approval expands the indications of use of this device to include children 9 to 12 months of age who have profound sensorineural hearing loss (SNHL) in both ears.

How does it work?
The internal component of the Nucleus 24 Cochlear Implant System is implanted by a surgeon. Sounds are picked up by the microphone of the external component and transformed into coded signals that are sent to the internal component of the implant system. The internal component of the implant system interprets the signals and sends electrical stimulation pulses to the cochlea of the inner ear. These stimulation pulses travel along the auditory nerve to the brain where they are interpreted as sound.

When is it used?
The Nucleus 24 Cochlear Implant System is intended to provide hearing to patients 9 months of age and older with appropriate candidacy criteria for deafness that is not improved by wearing hearing aids in both ears.

What will it accomplish?
The Nucleus 24 Cochlear Implant System, by providing useful hearing sensation, helps improve speech and language development associated with receptive or receptive-expressive language disorders in young children, including those aged 9-12 months who have profound SNHL in both ears.

When should it not be used?
The Nucleus 24 Cochlear Implant System should not be used in the following conditions:

• hearing loss due to lesions of the acoustic nerve or central auditory pathway
• active middle ear infections
• absence of cochlear development
• ruptured eardrum with active middle ear disease

Additional information (including warnings, precautions, and adverse events):

• Summary of Safety and Effectivenes Data (SSED)
• Physician Labeling
• PMA Database Entry