MED-EL’s MRI-Safe Cochlear Implant Gets FDA Green Light
MED-EL USA plans to launch its Synchrony cochlear implant in U.S. markets, following the receipt of FDA approval, the company said Friday. Synchrony is the only U.S.-approved cochlear implant that can be used with 3.0 Tesla magnetic resonance imaging devices without surgical removal of the internal magnet.
According to MED-EL, the Synchrony is the smallest and lightest titanium cochlear implant on the market, making it ideal for even the youngest candidates.
The implant is compatible with all of the company’s current audio processors, including its recently approved Sonnet. It is also “future-ready” for more advanced technologies as they become available, the Durham, N.C., devicemaker said.
Features include a conical design for the implant’s removable magnet housing, which greatly reduces the risk of magnet dislodgement or movement. A polymer stiffening ring within the silicone implant further secures the magnet housing, MED-EL said. Because the magnet can only be removed from the bottom side of the implant, dislocation due to trauma is nearly impossible, the company added. — Kellen Owings