FDA approves Cochlear’s Nucleus MRI-safe hearing aid

Cochlear Ltd. (ASX:COH) said today it won FDA premarket approval for its magnetic resonance imaging-compatible Nucleus cochlear implant.

The devices won clearance for use with up to 3.0T MRI machines with the unit’s magnet removed, and up to 1.5T machines with the use of the Centennial, Colo.-based company’s Cochlear Nucleus Implant Bandage and Splint Kit

“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. 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,” Cochlear NA prez Tony Manna said in a press release.

Cochlear said that it is the 1st to have introduced cochlear implants with removable magnets to allow for use during MRI scanning procedures.

Earlier this month, saw shares sag despite releasing fiscal year 2016 earnings that showed annual net profit growing 30% while overall sales were up almost 25%.

The Australian hearing aid giant reported profits of $144.9 million, or $2.54 per share, on sales of $888.6 million for the full 2016 fiscal year. That amounts to a 29.6% bottom-line gain as sales grew 23% compared with the pervious fiscal year.

The post FDA approves Cochlear’s Nucleus MRI-safe hearing aid appeared first on MassDevice.

from MassDevice http://ift.tt/2bxDf5v