MED-EL Cochlear Implant System - P000025/S104 wins USFDA approval

The MED-EL Cochlear Implant System gets the USFDA approval to produce auditory sensations. The intention of MED-EL Cochlear Implant System is to produce auditory sensations by giving electric stimulation in the cochlea.

Implantation of the internal parts of the MED-EL Cochlear Implant System is done by a surgeon. The product leads to direct stimulation of the cochlea of the inner ear with electrical signals. Transmission of these signals is done via the hearing nerve to the brain where they are interpreted as sound.

The MED-EL Cochlear Implant System is anticipated to give 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 asymmetric 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 should not be used in case of underdeveloped cochlea; abnormal auditory nerve; infection in external or middle ear and presence of structural abnormalities which may hinder in placement of stimulator.