Tag: FDA approval

Summary Cochlear Limited has received FDA approval for the Nucleus Nexa System, reportedly the world's first smart cochlear implant, which features upgradeable firmware, offering users ongoing access to new innovations and improved hearing performance. Key Takeaways The Nucleus Nexa Implant features upgradeable firmware and onboard diagnostics to give recipients future-proof access to new technology and better hearing care. The new Nucleus 8 Nexa Sound Processor is the world's smallest and lightest with all-day battery life, supported by smart algorithms that adapt power use to individual needs. Built-in memory and a connected digital ecosystem help users stay seamlessly connected to sound, even if a sound processor is lost or replaced. Cochlear Limited, known globally for its implantable hearing solutions, today announced the U.S. Food and Drug Administration (FDA) approval of the Cochlear Nucleus Nexa System, which the company says is the world's first and only smart cochlear implant system. FDA Greenlights Smart Cochlear Implant System Until now, recipients of cochlear implants have been limited to accessing new technology through the external part of their cochlear implant system – the sound processor – and have typically needed a new sound processor to fully experience the benefits of new technology. The new smart Nexa System has upgradeable implant firmware, which for the first time will enable Cochlear recipients to access future innovation through both their implant and sound processor. This new firmware update pathway will enhance recipients' sound processor upgrades to deliver their best possible hearing experience, giving recipients more ways to access new innovations over time. https://hearingreview.com/hearing-products/implants-bone-conduction/cochlear-implants/who-gets-a-ci-expanding-access-to-cochlear-implants Smaller, Lighter, and Smarter Design In addition, the new Nucleus 8 Nexa Sound Processor with the Power Compact rechargeable battery is reportedly the smallest and lightest sound processor with all day battery life on the market. Through a new algorithm running on the implant called Dynamic Power Management, the Nucleus Nexa System intuitively responds to recipients’ changing needs across the day, all while adapting to maximize battery life. It is 9% smaller and 12% lighter than the Nucleus 8 Sound Processor with the Power Extend battery allowing patients to benefit from all-day hearing wearing what the company calls the smallest and lightest sound processor in the world. New Chipset Enables Future Upgrades and Diagnostics "The Nucleus Nexa Implant is the first ever cochlear implant running its own firmware,” says Jan Janssen, chief technology officer at Cochlear. “Similar to smartphones, the implant firmware can be updated to enable new features and access future innovations. Recipients will now have access to their best possible hearing experience with both implant and sound processor updates. “The Nucleus Nexa System builds upon Cochlear's industry-leading portfolio of electrodes, which are designed to optimize the electrode-neural interface and protect cochlear health for a lifetime of hearing performance and opens the door to even greater hearing potential for patients into the future. While it uses the same implant form factor as the most reliable cochlear implant in the industry, the new Nexa Implant features a totally new and redesigned chipset packed with innovative and smart features. This includes onboard diagnostics, which takes the pressure off carers and recipients by allowing the system to check itself and monitor to ensure it is performing to the best of the recipient's hearing needs. This new system sets a new industry standard." https://hearingreview.com/hearing-products/implants-bone-conduction/cochlear-implants/early-cochlear-implant-activation-clinical-and-surgical-implementation-considerations Built-In Memory Enhances Flexibility for Users According to Cochlear, Nucleus Nexa It is also the first implant with internal memory, which enables unique hearing settings (MAPs) to be securely stored in the implant itself and which can be easily transferred to any Nucleus Nexa Sound Processor in the future, in case of a lost or damaged sound processor, making it easier to stay connected to sound. Integrated Ecosystem and Backward Compatibility The new system includes the Nucleus Nexa Implant, the Nucleus Kanso 3 Nexa Sound Processor, and the Nucleus 8 Nexa Sound Processor. The Nucleus Nexa Implant and sound processors are supported by an ecosystem of tools to enable best patient care and outcomes including Nucleus SmartNav, Nucleus Smart App, Custom Sound Pro fitting software and wireless accessories. In addition, those with Cochlear's legacy Nucleus Systems will be able to upgrade to the new Kanso 3 Sound Processor. Both the Kanso 3 Nexa and Kanso 3 Sound Processors are designed to deliver all the innovative features introduced with the Nucleus 8 Sound Processor, including SmartSound IQ 2 with SCAN and automated ForwardFocus. "The Nucleus Nexa Implant is innovative new technology that I am really excited about,” says Dr David Kelsall from Rocky Mountain Ear Center. “The smart implant innovation further solidifies my confidence in being able to provide the best outcomes for my patients today and in the future," Designed for Lifelong Hearing and Personalized Care Like with Cochlear's previous sound processor technology, the Nexa System is designed to be seamlessly connected to an ecosystem that delivers personalized care, a world of streaming options, and features rugged IP68 waterproofing for listening in every language environment. "With my cochlear implant, life has changed dramatically for me. Most importantly, I have been able to hear my family and that is my highest priority. I feel like I have been given a second chance and now I value the sounds that I hear with a child-like excitement and joy that I will never again take advantage of," says Lori Miller, recipient of the new Cochlear Nucleus Nexa System. Transforming Lives Through Better Hearing Over 5% of the world's population, 430 million people, live with disabling hearing loss. Up to 80% of children who received implants younger than 12 months demonstrated receptive vocabulary within the normal range by school entry. Hearing is not just about being able to hear words and sounds. It goes to the heart of a person's health, development, wellbeing, and overall quality of life. Availability The Nucleus Nexa System will be available in the late Summer. For further information, visit www.cochlear.com/NucleusNexa.

Tag: FDA approval

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