Cochlear Announces FDA Approval of Nucleus 8 CI Sound Processor

LONE TREE, COLORADO — Cochlear Limited (ASX: COH), a global leader in implantable hearing solutions, has announced U.S. Food and Drug Administration (FDA) approval for the Cochlear™ Nucleus^® 8 Sound Processor.

According to the company, the Nucleus 8 Sound Processor is now the smallest and lightest behind-the-ear cochlear implant sound processor available in the industry.^1-3 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^®.^1-3,#

The Nucleus 8 Sound Processor features Cochlear’s latest and most innovative hearing technology that can sense changes in a person’s environment and automatically adjust their listening settings.^4-7* It also includes an enhanced ForwardFocus⁺ feature, which effectively reduces distracting background noise to make face-to-face conversations clearer, especially in noisy environments.^{8,^} 

Cochlear says it is continuing 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.^9,± 

“Cochlear’s goal is to help people feel empowered to connect with their world and make it easier to hear and be heard. In a restaurant, at work, at school, or spending time with family and friends – life’s full of opportunities to engage with others. The Nucleus 8 Sound Processor is our smallest, lightest and smartest behind-the-ear sound processor yet and is designed to help people hear conversations more clearly and comfortably, wherever life may take them.”

–Lisa Aubert, President, Cochlear Americas

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 directly connect to everyday technology in more places and from more devices than ever before.^10-12,# 

People will be able to conveniently connect directly to broadcasts at public venues such as airports, conference centers, sport stadiums and gyms that support Bluetooth’s next generation Auracast™.

“Cochlear continues to lead in innovation that matters most, delivering smaller and smarter sound processors to improve hearing performance that’s comfortable and easy to use. The Bluetooth LE Audio connectivity in the Nucleus 8 Sound Processor will provide those with hearing loss new, more convenient ways to stream audio to their sound processor, including making it easier for children and adults to engage in the world around them. From the classroom to the conference room, we want to help reduce the stress of life’s interactions with the Nucleus 8 Sound Processor.”

–Ryan Lopez, Director, Nucleus Product Management & Marketing, Cochlear Americas

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.   

For those 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 level of severe to profound. However, conservative estimates suggest that only 1 in 20 adults worldwide who could benefit from a cochlear implant has one.^13,14 Better hearing can help people reach their full potential.

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.

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 seeing his father struggle with hearing loss. Since 1981, Cochlear has provided more than 700,000 devices in 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 with life’s opportunities, and welcomes them to the world’s largest hearing implant community.
Cochlear has a global workforce of more than 4,500 people, with a passion for progress, who strive to meet the needs of people living with hearing loss. The company continually innovates to anticipate future needs, investing more than AUD$2 billion to date in research and development to push the boundaries of technology and help more people hear.

 

_References

1. _{[cited 2022 Feb 28]. Available from: https://www.advancedbionics.com/}
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3. _{[cited 2022 Feb 28]. Available from: https://www.oticonmedical.com/}
4. _{Cochlear Limited D1864200 SCAN-X Design Description. Apr 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, Aug; 53(8): 564-576. [Sponsored by Cochlear]}
6. _{Mauger S, Jones M, Nel E, Del Dot J. Clinical outcomes with the Kanso™ off- the-ear cochlear implant sound processor. International Journal Of Audiology. 2017, Jan 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 Commercially Available Cochlear Implant Sound Processor. Otol Neurotol. 2015 Aug;36(7):1181-90. [Sponsored by Cochlear]}
8. _{Cochlear Limited. D1964109 Clinical Investigation Report CLTD5804. Feb 2022.}
9. _{Cochlear Limited. D1190805, Processor Size Comparison. May 2022.}
10. _{Hunn N. Introducing Bluetooth® LE Audio [Internet]. [cited 2022 Jan]. Available from: 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 from: https://www.bluetooth.com/blog/a-technical-overview-of-lc3.}
13. _{Sorkin D. Cochlear implantation in the world’s largest medical device market: utilization and awareness of cochlear implants in the United States. Cochlear Implants Int 2013;14(Suppl 1):S1.}
14. _{De Raeve L. Cochlear implants in Belgium: Prevalence in paediatric and adult cochlear implantation. Eur Ann Otorhinolaryngol Head Neck Dis 2016;133(Suppl 1):S57–60.}

_Disclaimers

• _{# When the technology becomes available for the Cochlear Nucleus 8 Sound Processor, a firmware update to your sound processor will allow you to connect to Bluetooth LE Audio compatible devices.}
• _{• Compared to Nucleus 6 and 7 Sound Processors.}
• _{+ ForwardFocus can only be enabled by a hearing implant specialist. It should only be activated for users 12 years and older who are able to reliably provide feedback on sound quality and understand how to use the feature when moving to different or changing environments. It may be possible to have decreased speech understanding when using ForwardFocus in a quiet environment.}
• _{^ Compared to Nucleus® 7 Sound Processor with ForwardFocus on.}
• _{± Comparison made using the Compact Battery Module for Nucleus 8 Sound Processor and the Compact Rechargeable Battery for Nucleus 7 Sound Processor.}
• _{•• Remote Check and Remote Assist are intended for ages 6 and older. Remote Check and Remote Assist features are only visible and accessible if they are enabled by a clinician. Clinicians should consider the suitability of the feature before enabling Remote Check and Remote Assist.}

_{The Bluetooth® and Auracast™ 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 health professional about treatments for hearing loss. Outcomes may vary, and your health professional will advise you about the factors which could affect your outcome. Always follow the directions for use. Not all products are available in all countries. Please contact your local Cochlear representative for product information.}

_{© Cochlear Limited 2022. All rights reserved.}