First MRI-Conditional Cochlear Implant Approved in U.S.

MED-EL USA has announced U.S. FDA approval of its new SYNCHRONY cochlear implant, the first time such a device has been approved for use with 3.0 Tesla (T) MRI without the surgical removal of the internal magnet.

Background

One problem for cochlear implants has hitherto been their incompatibility with MRI scanners. SYNCHRONY addresses the problem by featuring a freely rotating magnet which self-aligns within its titanium housing, greatly reducing implant torque and the risk of demagnetization during scans. This enables high-resolution 3.0T MRI scans without the need for magnet removal.

MED-EL  claims its implants are all designed to be future-ready for the latest technology as it becomes available. The company’s SYNCHRONY implant is compatible with all of its current audio processors, including the recently approved SONNET and is the smallest and lightest titanium cochlear implant on the market, allowing MED-EL to propose that it’s the ideal choice for even the youngest candidates.

Company comments

“MED-EL has continued its unprecedented advancement in the area of cochlear implant and MRI safety,” said Raymond Gamble, President & CEO, MED-EL North America. “We are thrilled to be able to offer SYNCHRONY, which has revolutionized the cochlear implant landscape around the world, here in the United States.”

Source: Business Wire

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