FDA Approves MRI-friendly Cochlear Implant

JUNE 17, 2019
Cecilia Pessoa Gingerich
FDA, The US Food and Drug Administration (FDA) has approved a new cochlear implant—the Cochlear Nucleus Profile Plus Series. The new implant was designed to be safe for MRI scans and implant users will not need to remove the internal magnet or use a head wrap for 1.5 and 3.0 Tesla (T) MRI scans.

"For more than 2 decades, Cochlear has been pleased to provide Nucleus Cochlear Implant recipients with access to MRIs," said Tony Manna, President, Cochlear Americas. "Now with the approval of the Nucleus Profile Plus Implant, we are able to provide our cochlear implant recipients MRI access without the need to remove the internal magnet or needing a head wrap at 1.5 and 3.0 T, improving the experience for both healthcare professionals and their patients."

The FDA also approved an integrated connectivity feature for the Nucleus 7 Sound Processor which allows users to directly connect with and stream audio from compatible Android phones.

"When a person chooses a cochlear implant, it begins a partnership between them and the cochlear implant company for the rest of their life. As the most chosen cochlear implant manufacturer with recipients all around the world, we at Cochlear understand our responsibility to innovate reliable implants and upgradeable sound processors that meet the needs of our customers today and in the future," said Patricia Trautwein, AuD, Vice President, Marketing and Product Management, Cochlear Americas.

The company announced that the Nucleus Profile Plus Series Cochlear Implant will become available this month, and the new features for the Nucleus 7 Sound Processor will become commercially available in the US and Canada this fall.

Related Coverage >>>
Copyright© MD Magazine 2006-2019 Intellisphere, LLC. All Rights Reserved.