WHITE BEAR LAKE, MINNESOTA — Envoy Medical announced that the it has received U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for the company’s Esteem Hearing Implant. The company says the designation makes their device the first and only active middle ear implant device to receive approval for MR-conditional labeling in both 1.5 and 3.0 Tesla (T) scanning environments.
Surgeons and audiologists who work closely with implanted devices like cochlear implants or middle ear implants are often asked about a device’s compatibility with MRI. Until now, middle ear implants have been contra-indicated for high resolution 3.0 T MRI scans, and all but one were also contra-indicated for 1.5 T scans.
MRI continues to be one of the most important imaging tools available for healthcare professionals to diagnose and monitor a wide range of health issues.
“MRI scans are widely used and seen as a preferred imaging tool across a variety of situations. We did not want people to have to make a choice between our device and the chance that they will need an MRI in the future. MR-conditional approval at both 1.5 and 3.0 Tesla gives Esteem patients the peace of mind that they can safely undergo certain MRIs without having to endure the additional surgeries, hassles, and costs to have the device partially or fully removed beforehand.”
–Brent Lucas, Envoy Medical CEO
“Most other implanted hearing devices contain magnets for one purpose or another. Some have a magnet that directly interacts with the middle ear bones while others have a magnet under the scalp to hold an external sound processor in place,” said Paul Mazanec, Envoy Medical’s Chief Technology Officer. “The Esteem does not contain any implanted magnets, which obviously reduces safety and comfort risks associated with magnetic coupling during MRI, but it also helps minimize the amount of image distortion around the implant. It is one thing to be able to get an MRI with an implant, that’s obviously great, but it is even better to know that the implant you have causes less image distortion and artifact than other devices around the implant itself, especially if you need an MRI of the head or neck,” said Mazanec.
Source: Envoy Medical