FDA Approves Smaller Cochlear Implant with Bluetooth Connectivity

The Nucleus 8 Sound Processor will be commercially available across the United States and Canada by the end of 2022.


Cochlear Limited has received FDA approval for the Cochlear Nucleus® 8 Sound Processor, what it calls the smallest and lightest behind-the-ear cochlear implant sound processor available.

The company said it is also the world's first cochlear implant sound processor ready to provide direct audio connectivity to everyday consumer electronics using the next generation LE Audio technology from Bluetooth.

The Nucleus 8 Sound Processor features Cochlear's latest hearing technology that can sense changes in a person's environment and automatically adjust their listening settings. It also includes an enhanced ForwardFocus+ feature, which effectively reduces distracting background noise to make face-to-face conversations clearer, especially in noisy environments. Cochlear continues its commitment to reduce the size of each processor generation with the new behind-the-ear sound processor being 15 percent smaller and 13 percent lighter than its predecessor.

The Nucleus 8 Sound Processor builds on the direct streaming capabilities available in Cochlear's latest sound processors. With access to next-generation Bluetooth LE Audio, it will be easier to directly connect to everyday technology in more places and from more devices than ever before. People will be able to connect directly to broadcasts at public venues such as airports, conference centers, sport stadiums and gyms that support Bluetooth's next generation Auracast.

In addition to the Nucleus 8 Sound Processor, Cochlear is expanding its Connected Care solutions for Nucleus Implant System recipients. Building upon the ability to let cochlear implant recipients adjust their own processor settings and access Remote Care options from their mobile phone, enhancements to the Nucleus Smart App will enable future improvements to the bimodal control experience and provide access to Remote Firmware updates, so patients can conveniently access the latest technology without a trip to the clinic.

The Nucleus 8 Sound Processor will be commercially available across the United States and Canada by the end of 2022. The Nucleus 8 Sound Processor has been approved by Health Canada.

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