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: MED-EL Cochlear Implant System
PMA Applicant: MED-EL Corp.
Address: Fürstenweg 77a, 6020 Innsbruck, Austria
Approval Date: 7/19/2019
Approval Letter: Approval Order
What is it? The MED-EL Cochlear Implant System is intended to produce auditory sensations by providing electric stimulation in the cochlea.
This approval expands the current cochlear implantation indications to include patients 5 years and older with single sided deafness (SSD) and asymmetric hearing loss (AHL) who have profound sensorineural hearing loss in the ear to be implanted and normal hearing or mild to moderate sensorineural hearing loss in the other ear.
How does it work? The internal parts of the MED-EL Cochlear Implant System are implanted by a surgeon. The MED-EL Cochlear Implant System directly stimulates the cochlea of the inner ear with electrical signals. These signals are transmitted via the hearing nerve to the brain where they are interpreted as sound.
When is it used? The MED-EL Cochlear Implant System is intended to provide hearing to patients with single sided deafness (SSD) who have one deaf ear and normal hearing or mild sensorineural hearing loss in the other ear or patients with assymetric hearing loss (AHL) who have one deaf ear and mild to moderate sensorineural hearing loss in the other ear. The MED-EL Cochlear Implant System can help with hearing better in noisy listening situations.
Before implantation, individuals with SSD or AHL must have at least one (1) month experience with a Contra Lateral Routing of Signal (CROS) hearing aid or other relevant non-implantable device and not obtain any benefit.
What will it accomplish? The MED-EL Cochlear Implant System is intended to improve speech understanding in noise, sound localization, and self-perceived quality of hearing in SSD and AHL patients.
When should it not be used? The MED-EL Cochlear Implant System should not be used if:
- The cochlea is not fully developed
- The cause of deafness is due to the abnormal auditory nerve and/or the central auditory pathway not working appropriately
- External or middle ear infections are present or if there is a hole or tear in the eardrum (tympanic membrane) in the ear to be implanted
- There are medical reasons against surgery of the middle and inner ear and anesthesia as required
- There are structural abnormalities that would prevent appropriate placement of the stimulator housing in the bone of the skull or prevent placement of the chosen electrode array into the cochlea. In such cases, using the cochlear implant must be carefully considered prior to surgery
In addition, the MED-EL Cochlear Implant System is not recommended for patients who:
- Cannot tolerate materials used in the implant (medical grade silicone, platinum, platinum iridium)
- Are considered to be emotionally and psychologically unstable
- Have unrealistic expectations
- Have had had profound hearing loss for over ten years
- Have an acoustic neuroma
Additional information (including warnings, precautions, and adverse events):
- Summary of Safety and Effectiveness Data (SSED)
- Labeling: Sound Processor - User Manual
- PMA Database Entry