biospectrumasiaJune 18, 2019
Tag: FDA , Cochlear implant , MRI
Cochlear Limited, the global leader in implantable hearing solutions announced the U.S. Food and Drug Administration's (FDA) approval of the new Cochlear™ Nucleus®Profile™ Plus Series Cochlear Implant and the Nucleus 7 Sound Processor's new built-in connectivity featuring direct streaming with compatible Android™ smartphones.
The Nucleus Profile Plus Implant is designed for safe access to Magnetic Resonance Imaging (MRI) scans today and in the future. With the Nucleus Profile Plus Implant, cochlear implant recipients have easier access to 1.5 and 3.0 Tesla (T) MRI scans without the need to remove the internal magnet or use a head wrap. The new implant is built off Cochlear's Nucleus Profile Series Implant, which maintains an accessible magnet if removal is ever required.
The Nucleus Profile Plus Implant is built on Cochlear's unrivaled cochlear implant reliability record of the Profile Implant and the entire Cochlear Nucleus implant portfolio. The Nucleus Profile Plus Implant also includes a thin design5, providing cochlear implant recipients the potential of a better cosmetic outcome and less time in surgery.
With FDA approval, as well as Health Canada's approval, of the Nucleus 7 Sound Processor's expanded connectivity features, Cochlear is also the first cochlear implant manufacturer to enable access of direct audio streaming from Android devices to its cochlear implant sound processor without any intermediary device or attachments needed to be added to the sound processor.
Since the Nucleus 7 Sound Processor was first launched in 2017 as the world's first Made for iPhone cochlear implant sound processor and the announcement of the Nucleus Smart App compatibility with Android devices in 2018, Cochlear has continued to work to extend the benefits of its industry-leading technology to Android smartphone users as the technology has come available. With the updates, the Nucleus 7 Sound Processor continues to remain the industry's smallest and lightest behind-the-ear cochlear implant sound processor.
"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. "In addition, our commitment extends beyond the product portfolios to include service innovations being realized with future-thinking connectivity that are transforming hearing healthcare."
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