Envoy Medical ’s hearing implant wearers can get MRIs

Image by Gerd Altmann, courtesy of Pixabay. The FDA has given Envoy Medical’s landmark Esteem middle-ear implant clearance for MR-conditional labeling in both 1.5 and 3.0 Tesla (T) scanning environments. White Bear Lake, Minn.-based Envoy introduced the Esteem — the first fully implantable device to treat hearing loss in the U.S. — in 2010. Surgeons and audiologists who work closely with hearing implants are often asked about a device’s compatibility with MRI. It has been seen as a limitation of middle ear implants that all of them were contra-indicated for “high-resolution” 3.0 T scans, and all but one were also contra-indicated for 1.5 T. Get the full story on our sister site, Medical Design & Outsourcing. The post Envoy Medical’s hearing implant wearers can get MRIs appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog Implants Regulatory/Compliance Envoy Medical Corp. FDA Source Type: news