New MED-EL cochlear implant can be used with MRI, FDA finds

 

 

DURHAM, NC–One drawback of wearing a cochlear implant (CI) is that it creates complications for CI wearers who need to undergo an MRI  (magnetic resonance imaging).  Doing an MRI scan of the head with the CI in place can prevent an accurate scan from being produced.  Worse yet, scanning any part of the body with the implant in place can damage the CI or even cause injury to the wearer.

MRI, which provides detailed images of soft tissue and joints, is commonly used to detect serious health problems, including cancer and heart disease, and then to determine appropriate treatment.  Tens of million of MRIs are performed each year in the U.S., and the number is growing, so the limitations on their use with cochlear implants are a serious concern for patients who have CIs.

 

GETTING AN MRI MAY REQUIRE SURGERY

Because of this issue, CI users in the U.S. have often been required, before getting an MRI, to have the internal magnet of their implant surgically removed. Then, after the scan, a second surgery is required to reinstall the magnet.

SYNCHRONY_image

Now, however, one cochlear implant manufacturer has found a way to address the problem. Last week, MED-EL USA announced that its new Synchrony system, which, unlike other CIs, uses a diametric magnet, has received approval from the U.S. Food and Drug Administration (FDA) for use with 3.0 Tesla (T) MRI without removal of the internal magnet.

This, said the U.S. division of the Austrian parent company, is the only implant so designated by the FDA. Synchrony will be available this spring.

In June 2013, the FDA cleared three other models of MED-EL implants–Pulsar, Sonata, and Concert—for use with 1.5T MRI with the internal magnet in place. However, the more powerful 3.0T MRIs are the state of the art and are increasingly superseding 1.5T scans.