Nucleus® Hybrid™ L24 Cochlear Implant System – P130016
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® Hybrid™ L24 Cochlear Implant System
PMA Applicant: Cochlear Americas
Address: 13059 East Peakview Avenue, Centennial, CO 80111
Approval Date: March 20, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130016a.pdf
What is it?
The Nucleus® Hybrid™ L24 Cochlear Implant System (also referred to as “Hybrid L24”) is a cochlear implant system used to treat certain hearing losses caused by a defective inner ear function. The Hybrid L24 is designed to allow patients to hear in two ways: electrically (similar to approved cochlear implants) for severe to profound hearing loss at mid and high frequencies, and acoustically (similar to hearing aids) for normal to moderate hearing loss at low frequencies.
The Hybrid L24 includes an implant consisting of a receiver/stimulator and an intracochlear electrode array, an externally worn sound processor that can be fit with an acoustic component, programming software/instruments, and various remote control options.
How does it work?
Using a small microphone, the sound processor picks up sound from the patient’s surroundings and separates it into different groups of sounds by frequency (that is, the low or high "pitch" of a sound). The higher frequency information about the sound is sent to the receiver/stimulator and electrode array of the implanted part of the device. Since the electrode array is located inside the patient’s cochlea, this sound-related information is relayed to the brain, allowing the patient to hear.
For patients who have enough of their own acoustic low-frequency hearing after implantation, the sound processor also provides amplified low-frequency sound to the patient’s ear through the acoustic component. After implantation, some patients do not have enough low-frequency hearing to use the acoustic component. These patients hear only electrically using the implant for all (lower and higher) sound frequencies.
When is it used?
The Hybrid L24 is intended for use in one ear by patients aged 18 years or older who obtain limited benefit from appropriately fit hearing aids in both ears and meet the following criteria:
- Typical preoperative hearing of candidates ranges from normal to moderate hearing loss in the low frequencies, with severe to profound loss in the mid to high frequencies.
- The consonant nucleus consonant (CNC) word recognition score will be between 10% and 60%, inclusively, in the ear to be implanted in the preoperative aided condition and in the other ear will be equal to or better than that of the ear to be implanted but not more than 80% correct.
- Previously have undergone a suitable hearing aid trial, unless already appropriately fit with hearing aids.
What will it accomplish?
Fifty subjects participated in a clinical study across 10 sites. On the average, the device improved speech recognition in both quiet and noisy listening situations, and most subjects experienced improvement. Subjects with better low-frequency hearing postoperatively tended to perform better. Nearly half of the subjects experienced a significant loss of low-frequency hearing, and six subjects (12%) were explanted and reimplanted with a traditional cochlear implant. For subjects who lost low-frequency hearing and retained use of the device, most benefitted from the electrical hearing provided.
When should it not be used?
A Hybrid L24 should not be used for individuals who have the following conditions:
- Deafness due to lesions of the acoustic nerve or central auditory pathway
- Active middle ear disease, with or without tympanic membrane perforation
- Absence of cochlear development
- A duration of severe to profound hearing loss of 30 years or greater
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.