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June 18, 2019

FDA approves Cochlear Nucleus Profile Plus Series implant

The US Food and Drug Administration (FDA) has approved the new Cochlear Nucleus Profile Plus Series Cochlear Implant and the Nucleus 7 Sound Processor’s new built-in connectivity which features direct streaming with compatible Android smartphones.

The US Food and Drug Administration (FDA) has approved 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 has been designed for safe access to Magnetic Resonance Imaging (MRI) scans.

It includes a thin design and offers cochlear implant recipients the potential of a better cosmetic outcome and less time in surgery. The device also maintains an accessible magnet if removal is ever required.

Cochlear Americas president Tony Manna said: “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.”

The approval from the FDA allows Nucleus 7 recipients the ability to connect to compatible Apple and Android devices.

Access to direct streaming between the Nucleus 7 Sound Processor and an Android phone is dependent upon the phone manufacturers implementing Google’s Audio Streaming for Hearing Aids (ASHA) protocol into future operating system updates for their handsets.

The Nucleus Profile Plus Series Cochlear Implant, which is still awaiting Health Canada approval, will be commercially available later this month.

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