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FDA Approves Cochlear’s Nucleus 8 Sound Processor, Smaller, Smarter, Better-Connected Cochlear Implant Technology

The Nucleus 8 sound processor is the world’s first cochlear implant sound processor compatible with Bluetooth LE Audio technology

LONE TREE, Colo., November 1, 2022 /PRNewswire/ — Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, receives U.S. Food and Drug Administration (FDA) approval for the Cochlear™ Nucleus® 8 sound processor. Nucleus 8 sound processor is now the smallest and lightest behind-the-ear cochlear implant sound processor available on the market. 1-3 It’s also the world’s first cochlear implant sound processor ready to deliver direct audio connectivity to everyday consumer electronics using Bluetooth®’s next-generation LE Audio technology.1-3.#

Check out the full interactive multi-channel press release here: https://www.multivu.com/players/English/9002251-cochlear-fda-approval-for-cochlear-nucleus-8-sound-processor/

The Nucleus 8 sound processor features the latest and most innovative hearing technology from Cochlear, capable of detecting changes in a person’s environment and automatically adjusting their listening settings.4-7* It also includes an improved ForwardFocus+ feature, which effectively reduces distracting background noise to make face-to-face conversations clearer, especially in noisy environments.8, ^ Cochlear continues its commitment to downsizing with each processor generation, with the new behind-the-ear sound processor being 15% smaller and 13% lighter than its predecessor.9, ±

To learn more about the Nucleus 8 Sound Processor, visit www.Cochlear.US/Nucleus8.

“Cochlear’s goal is to help people feel empowered to connect with their world and make listening and listening easier,” said Lisa Aubert, President, Cochlear Americas. “Whether at restaurants, at work, at school, or spending time with family and friends, life is full of opportunities to engage with others. The Nucleus 8 Sound Processor is our edge sound processor. smallest, lightest and smartest earbud to date and is designed to help people hear conversations more clearly and comfortably, wherever life takes them.”

Smaller, smarter and better connected

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 than ever to connect directly to everyday technology in more places and from more devices than ever before.10-12.# People will be able to easily connect directly to broadcasts in public places such as airports, conference centers, sports stadiums and gymnasiums that support the next generation Auracast™ of Bluetooth.

“Cochlear continues to be at the forefront of the most important innovation, delivering smaller, smarter sound processors to improve hearing performance that are comfortable and easy to use,” said Ryan Lopez, Director, Nucleus Product Management and Marketing, Cochlear Americas. “The Nucleus 8 Sound Processor’s Bluetooth LE Audio connectivity will provide people with hearing loss new, more convenient ways to stream audio to their sound processor, including making it easier for children and adults to engage with the world around them. From the classroom to the boardroom, we want to help take the stress out of life’s interactions with the Nucleus 8 Sound Processor.”

In addition to the Nucleus 8 sound processor, Cochlear is expanding its connected care solutions for Nucleus implant system wearers. Build on the ability to let cochlear implant recipients adjust their own processor settings and access care remotely** options from their mobile phone, enhancements to the Nucleus Smart App will further enhance the bimodal control experience and provide access to firmware updates over the air, so patients can easily access the latest technology without having to go to the clinic.

For people living with severe to profound sensorineural hearing loss, cochlear implants are a proven medical treatment option. Cochlear implants are the most appropriate option to treat hearing loss when it has reached the severe to profound level. However, conservative estimates suggest that only 1 in 20 adults worldwide who could benefit from a cochlear implant have one.13.14 Better hearing can help people reach their full potential.

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

About Cochlear Limited (ASX: COH)

People have always been Cochlear’s inspiration, ever since Professor Graeme Clark set out to create the first multi-channel cochlear implant after watching his father struggle with hearing loss. Since 1981, Cochlear has delivered over 700,000 devices to more than 180 countries, helping people of all ages around the world to hear. As the global leader in implantable hearing solutions, Cochlear connects people to life’s opportunities and welcomes them to the world’s largest hearing implant community.

Cochlear employs more than 4,500 people around the world, passionate about progress, who strive to meet the needs of people living with hearing loss. The company continually innovates to anticipate future needs, investing more than A$2 billion in research and development to date to push the boundaries of technology and help more people hear.

www.cochlear.com/us

References

  1. [cited 2022 Feb 28]. Available at: https://www.advancedbionics.com/
  2. [cited 2022 Feb 28]. Available at: https://www.medel.com/
  3. [cited 2022 Feb 28]. Available at: https://www.oticonmedical.com/
  4. Cochlear Limited D1864200 SCAN-X Design Description. April 2022.
  5. Mauger SJ, Warren C, Knight M, Goorevich M, Nel E. Clinical evaluation of the Nucleus 6 cochlear implant system: performance improvements with SmartSound iQ. International journey of audiology. 2014, August; 53(8): 564-576. [Sponsored by Cochlear]
  6. Mauger S, Jones M, Nel E, Del Dot J. Clinical results with the Kanso™ off-ear cochlear implant sound processor. International Journal of Audiology. 2017, January 9; 1-10. [Sponsored by Cochlear]
  7. Wolfe J, Neumann S, Marsh M, Schafer E, Lianos L, Gilden J, O’Neill L, Arkis P, Menapace C, Nel E, Jones M. Benefits of adaptive signal processing in a cochlear implant sound processor commercially available. Otol Neurotol. 2015 Aug;36(7):1181-90. [Sponsored by Cochlear]
  8. Cochlear Limited. D1964109 Clinical Investigation Report CLTD5804. February 2022.
  9. Cochlear Limited. D1190805, CPU Size Comparison. May 2022.
  10. Hunn N. Introducing Bluetooth® LE Audio [Internet]. [cited 2022 Jan]. Available at: https://www.bluetooth.com/learn-about-bluetooth/recent-enhancements/le-audio/.
  11. Cochlear Limited. D1631375 Nucleus 8 Sound Processor Product Definition.
  12. A technical overview of LC3 [Internet]. Bluetooth® technology website. [cited 2022 Feb 28]. Available at: https://www.bluetooth.com/blog/a-technical-overview-of-lc3.
  13. Sorkin D. Cochlear implantation in the world’s largest medical device market: use and awareness of cochlear implants in United States. Cochlear Implants Int 2013;14(Suppl 1):S1.
  14. By Raeve L. Cochlear Implants in Belgium: Prevalence in pediatric and adult cochlear implantation. Eur Ann Otorhinolaryngol Head Neck Dis 2016;133(Suppl 1):S57–60.

Disclaimer

# When the technology becomes available for the Cochlear Nucleus 8 Sound Processor, a firmware update for your sound processor will allow you to connect to Bluetooth LE Audio enabled devices.
* Compared to Nucleus 6 and 7 sound processors.
+ ForwardFocus can only be activated by a hearing implant specialist. It should only be enabled for users 12 years and older who are able to provide reliable feedback on sound quality and understand how to use the feature when moving through different or changing environments. Speech understanding may be reduced when using ForwardFocus in a quiet environment.
Ù Compared to Nucleus® 7 Sound Processor with ForwardFocus enabled.
± Compared with Nucleus 8 Sound Processor Compact Battery Module and Nucleus 7 Sound Processor Compact Rechargeable Battery.
**Remote Verification and Remote Assistance are intended for children 6 years and older. Remote Check and Remote Assistance features are only visible and accessible if enabled by a clinician. Clinicians should evaluate the suitability of the feature before enabling remote verification and remote assistance.

Bluetooth® and AuracastMT the word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Cochlear Limited is under license.

Please seek advice from your healthcare professional on treatments for hearing loss. Results may vary, and your healthcare professional will advise you on factors that may affect your results. Always follow the instructions. Not all products are available in all countries. Please contact your local Cochlear representative for product information.

© Cochlear Limited 2022. All rights reserved.

SOURCE Cochlear Limited