First MRI-Compatible Cochlear Implant in U.S. Approved by FDA

Durham, N.C.-based Med-El USA has earned U.S. Food and Drug Administration approval for the new Synchrony cochlear implant. The device has been approved for use with a 3.0 Tesla (T) MRI (magnetic resonance imaging) machine without surgical removal of the internal magnet. It is the only implant available in the United States with this indication, and it will be available in the spring of this year, the company said.

“Med-El has continued its unprecedented advancement in the area of cochlear implant and MRI safety,” said Raymond Gamble, president and CEO, Med-El North America. “We are thrilled to be able to offer Synchrony here in the United States.”

Synchrony is compatible with all current Med-El audio processors, including the recently approved Sonnet. It is designed to be future ready for the latest technology as it becomes available. It is the smallest and lightest titanium cochlear implant on the market, making it the ideal choice for even the youngest candidates.

During an MRI, Synchrony’s magnet freely rotates and self-aligns within its titanium housing, greatly reducing implant torque and the risk of demagnetization during MRI scans. This design enables high-resolution 3.0T MRI scans without the need for magnet removal.
The implant can be used in the MRI machine because the conical design of the removable magnet housing greatly reduces the risk of magnet dislocation or migration, according to the company. The implant features a polymer stiffening ring within the silicone implant body to further secure the magnet housing. The magnet only can be removed from the bottom side of the implant, making dislocation of the magnet due to trauma almost impossible.

The implant is MR conditional, allowing MRI scans at 3.0T with the magnet in place. Synchrony’s magnet housing also can be substituted with a non-magnetic spacer for MRI head scans with minimal image distortion in the implant area. The removable magnet housing features a protective coating to prevent unwanted cellular adhesion, simplifying the removal and replacement of the implant magnet. The incision for magnet exchange is made beside the implant, rather than directly over the implant, allowing uninterrupted hearing.

The Synchrony pin implant option also features titanium fixation pins proven to secure the placement of the implant for stability. Synchrony incorporates Med-El’s Flex electrode arrays, which provide complete coverage of the cochlea and are engineered to preserve delicate cochlear structures for future advancements.