Abi implant8/28/2023 ![]() ![]() 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. 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. These stimulation pulses travel along the auditory nerve to the brain where they are interpreted as sound. The internal component of the implant system interprets the signals and sends electrical stimulation pulses to the cochlea of the inner ear. 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. This is still the largest patient population receiving these devices. The internal component of the Nucleus 24 Cochlear Implant System is implanted by a surgeon. The auditory brainstem implant was first developed to provide sound stimulation to neurofibromatosis type 2 (NF2) patients with bilateral damage to auditory nerves caused by acoustic neuroma tumors. 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. The Nucleus 24 Cochlear Implant System was previously approved for use in patients ages 12 months and older. The system consists of an internal and an external component. 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). Product Name: Nucleus 24 Cochlear Implant SystemĪddress: 13059 East Peakview Avenue, Centennial, CO 80111 ![]() 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. ![]() An auditory brainstem implant has two parts: an external part (the ‘processor’, worn on the ear) and the surgically implanted internal part. This is a brief overview of information related to FDA’s approval to market this product. Auditory Brainstem Implants (ABI) are suitable for those with a profound sensorineural hearing loss, leading to near total loss of sound. ![]()
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