FDA approves Cochlear Nucleus cochlear implants for MRI compatibility
Centennial : Cochlear Limited the global leader in implantable hearing solutions, announces the U.S. Food and Drug Administration (FDA) approved Nucleus implants for magnetic resonance imaging (MRI) use up to 3.0T with the magnet removed. Additionally, with the use of the Cochlear Nucleus Implant Bandage and Splint Kit, Nucleus implants are approved for 1.5T MRI with the magnet in place.
Inside each cochlear implant is a magnet, and nearly 20 years ago Cochlear was the first to introduce a key safety feature to ensure MRI compatibility for its implants: a removable magnet. The removable magnet ensures customer safety and comfort if an MRI is needed and an alternative imaging option is not available. The magnet is easy to remove and replace with a minor procedure if needed.
Cochlear's removable magnet is the gold standard for MRI and is reinforced by radiologists. Of radiology professionals surveyed, 97 percent do not recommend conducting MRI scans on patients with magnets in their bodies.1 The ability to remove the magnet provides optimal image quality and reduced artifact, a shadow cast by the magnet.2
"Cochlear has always taken the lead in adapting our implants to MRI technology to ensure customer safety and comfort, as well as protecting the efficacy of our Cochlear implant products that our customers depend on to hear," said Tony Manna, President of Cochlear North America. "We are proud to be able to provide a range of MRI options including the removable magnet and the splint kit for our customers and their medical professionals to ensure safety, efficiency and convenience for all."
If a 1.5T MRI with the magnet in place is needed, the Cochlear Nucleus Implant Bandage and Splint Kit can be ordered by clinics and hospitals, individual radiology clinics and Cochlear customers. The kits will be provided at no charge when ordered to minimize any financial burden to our customers and medical professionals.