DURHAM, NC—Med-El USA announced on June 14 that the U.S. Food and Drug Administration (FDA) has given its approval for wearers of three models of Med-El cochlear implants to undergo magnetic resonance imaging with 1.5 Tesla (T) MRI systems while leaving the internal magnet of their cochlear implant system in place.
The federal agency’s decision, which is expected to take effect by the end of this summer, will mean that wearers of Med-El’s Pulsar, Sonata, and Concert implants will no longer be required to have the magnet surgically removed before getting 1.5T MRI scans and then surgically replaced after the procedure. According to Med-El, its cochlear implants are the only ones available in the United States to have received this approval from the FDA.
Since 2001, all Med-El cochlear implants have been FDA approved for 0.2T MRI scans with the magnet in place. However, Med-El says, FDA approval of MRI imaging at 1.5T, the standardly used resolution, means that physicians will be able to obtain higher resolution imaging without removal and replacement of the magnet. This will allow better diagnosis and treatment, and will substantially benefit cochlear implant users who have chronic conditions, such as heart disease, cancer, and neuromas, that may require the regular use of MRI technology.
More than 32 million MRIs were performed in the U.S. in 2011, and the number is steadily increasing.
MED-EL Medical Electronics, a privately held company based in Austria, has more than 1400 employees around the world.