New Cochlear implant having safe access to MRI scans gets FDA nod
US Food and Drug Administration, FDA grants approval to a new Cochlear implant that has safe access during Magnetic Resonance Imaging.
New Cochlear implant designed for safe access to Magnetic Resonance Imaging (MRI) scans got approval from the US Food and Drug Administration, FDA. The device offers 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. This Cochlear implant is manufactured by Cochlear Limited, the global leader in implantable hearing solutions.
The new Cochlear™ Nucleus® Profile™ Plus Series Cochlear Implant and the Nucleus 7 Sound Processor’s new built-in connectivity provides direct streaming with compatible Android™ smartphones. 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 unrivalled cochlear implant reliability record of the Profile Implant and the entire Cochlear Nucleus implant portfolio. The Nucleus Profile Plus Implant also includes a thin design, providing cochlear implant recipients the potential of a better cosmetic outcome and less time in surgery.
With Food and Drug Administration 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.
This approval allows Nucleus 7 recipients the ability to connect to compatible Apple® and Android devices without compromising on size, weight or battery life of the sound processor. Access to direct Android streaming between the Nucleus 7 Sound Processor and a compatible Android phone is dependent upon Android phone manufacturers implementing Google’s Audio Streaming for Hearing Aids (ASHA) protocol into future operating system updates for their handsets.
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.
“For more than two 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. We are delivering this new innovation without sacrificing our longstanding cochlear implant reliability track record, our thin implant design and the easy to access magnet that ensures our recipients have continued MRI access now and in the future.”
“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.”
The Nucleus Profile Plus Series Cochlear Implant will be commercially available later this month. The Nucleus Profile Plus Series Cochlear Implant is still awaiting approval by Health Canada.