Cochlear Implants
by Cochlear Guest Author

FDA approves Cochlear’s Nucleus 8 Sound Processor, smaller, smarter, better connected cochlear implant technology

November 1, 2022
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The Nucleus 8 Sound Processor is the world’s first cochlear implant sound processor ready for Bluetooth LE Audio technology

Lone Tree, Colo. (November 1, 2022) — Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, receives U.S. Food and Drug Administration (FDA) approval for the CochlearTM Nucleus® 8 Sound Processor. 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 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.9, ± 

For more on 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 it easier to hear and be heard,” said Lisa Aubert, President, Cochlear Americas. “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.”

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,” said Ryan Lopez, Director, Nucleus Product Management & Marketing, Cochlear Americas. “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.”

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.

www.cochlear.com/us

References

  1. [cited 2022 Feb 28]. Available from: https://www.advancedbionics.com/
  2. [cited 2022 Feb 28]. Available from: https://www.medel.com/
  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 AuracastTM 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.

Author

Cochlear Guest Author

In an effort to keep our content fresh and reflective of a diverse industry, Cochlear Americas features a mix of employees and professional partners to contribute to Cochlear ProNews as Guest Authors.

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Cedric Pritchett

Research spotlight with Dr. Pritchett: Racial and Insurance Inequalities in Access to Early Pediatric Cochlear Implantation

October 18, 2021

Hear from Dr. Pritchett on the recent publication of Racial and Insurance Inequalities in Access to Early Pediatric Cochlear Implantation:

What inspired you to research this topic?

In the state of Florida we have a rich depth of diversity in culture, ethnicity and language. Nearly 40% of the children with hearing loss in our program have parents whose primary language is Spanish. We were desirous of understanding whether in this diversity, disparities existed.

What surprised you the most? What insights from this study were the most compelling to you and your team?

I was most surprised to learn heritage from African descent was the most predictive factor in delay to early implantation. Black children were less likely than White or Hispanic children to be implanted by two years of age (and even less so for one year of age). Demonstrating in the state of Florida, it is not unexpected for implantation of children with public insurance to occur later than children with commercial insurance; however, I did not expect to find racial background was more important than insurance status. In our study we discovered a Black child with commercial insurance was less likely to be implanted early than a White child of any insurance status—commercial, public, or self-pay, or a Hispanic child of commercial status; and with nearly the same likelihood as a Hispanic child with public insurance. In other words, the only children who were less likely to be implanted later than a Black child with commercial insurance were Black children with public insurance.

Have the findings from this study changed your team’s approach to managing children with severe to profound hearing loss? If so, how?

Realizing the existence of unequal odds for early implantation in our patient population has informed, but not changed our practice. Our team remains dedicated and intentional in our approach to provide timely access to sound in general, and cochlear implantation in particular for our children with hearing loss.

Your study references the importance of a multidisciplinary team. Can you tell us a little bit about how your team is structured? What has made your team successful?

Recently we reviewed our program’s outcomes measuring time to implantation based on several factors including race, insurance status and preferred spoken language of our patients’ caregivers. We were pleased to see such times were similar comparing the different categories within these variables. Our team has included a neurotologist, pediatric otolaryngologist, two implant audiologists, two speech pathologists/auditory verbal therapist, a pediatric nurse practitioner, a registered nurse, a licensed clinical social worker, an implant coordinator and clinical assistant. We have been very fortunate to have the presence of a dedicated social worker and several members of our team who are fluently bilingual (Spanish), including one implant audiologist and at one point both speech pathologists. These assets in our program have provided crucial insight into our families’ needs and perspectives, and then supported our program’s band width to address them.

Any key takeaways that professionals should know?

We recognize our children are the future, but this is especially worth emphasizing in the context of children with hearing loss disabilities/disadvantages. We understand children are typically dependent participants in the care they receive. Pediatric care is best delivered in a multidisciplinary team. A team involving clinicians and therapists, but also educators and family members. Our teams should be prepared to investigate at the least, and ideally mitigate the underlying challenges to optimal care our children-patients encounter.

Read more on this topic here!

Citation:

Liu X, Rosa-Lugo LI, Cosby JL, Pritchett CV. Racial and Insurance Inequalities in Access to Early Pediatric Cochlear Implantation. Otolaryngol Head Neck Surg. 2021 Mar;164(3):667-674. doi: 10.1177/0194599820953381. Epub 2020 Sep 15. PMID: 32930656.

About the author:

Dr. Pritchett is a Pediatric Otolaryngologist- Head & Neck Surgeon with Nemours Children’s Health System at the Nemours Children’s Hospital in Orlando, FL.  His scope of practice includes a range of pediatric otolaryngology conditions with particular interest in pediatric otology and hearing loss. He is a cochlear implant surgeon, presently serves as Medical Director of both the Nemours Children’s Hospital’s Cochlear Implant Program and Section of Audiology, and is an affiliated Associate Professor in Otolaryngology at the University of Central Florida’s College of Medicine. Dr Pritchett received his Medical Degree and Master’s in Public Health from The Ohio State University in Columbus, OH. Residency in Otolaryngology-Head & Neck Surgery was completed at the University of Michigan, in Ann Arbor, MI, and fellowship in Pediatric Otolaryngology at Northwestern University’s Ann & Robert Lurie Children’s Hospital of Chicago. Dr. Pritchett is a member several professional societies including the Academy of Otolaryngology – Head and Neck Surgery, and is a fellow of the American Society of Pediatric Otolaryngology, and the American Academy of Pediatrics. He has served as a reviewer for several journals, including the Laryngoscope, Otolaryngology-Head and Neck Surgery, and International Journal of Pediatric Otorhinolaryngology. He is the author of a number of articles and enjoys sharing his knowledge with training healthcare professionals from all backgrounds. He has been married for over 20 years, and has two wonderful daughters. He enjoys traveling, reading, is attempting to become a photographer, and looking to become more involved in mission work.

girl learning in classroom

Clinical Quick Tips: See how the Cochlear™ Mini Microphone 2+ can help your patients in the classroom

August 9, 2018

Clinical Quick Tips

Flexibility in the Classroom: the Cochlear™ Mini Microphone 2+

By guest author: Janet Clarke, Au.D.

Janet Clarke

The Cochlear™ Nucleus® 6 (CP910, CP920), Kanso®(CP950), and Nucleus 7 (CP1000) Sound Processors, the Cochlear Baha® 5 series Sound Processors, ReSound hearing technology, and the Cochlear Mini Microphone 2+ (MM2+) are all great friends in the classroom! Direct streaming from the MM2+ to the processor(s), or processor and hearing instrument, offers a discreet option for enhanced listening to classroom instruction. No additional hardware is attached to the sound processor and/or hearing instrument. The MM2+ can be either worn by the teacher, used as a tabletop conference microphone, used to receive audio from a room loop via the Telecoil setting, or used with another audio input via the Line-in Direct Audio Input.

Cochlear™ Baha® with Mini Microphone 2+ (MM2+) and school

By guest author: Amy Donaldson, Au.D.

Children in schools today often find themselves in dynamic learning environments, especially where listening is concerned. The “typical” classroom, where the teacher stands in the front of the room to lecture while the student spends all day listening, is truly becoming a relic of the past. Today’s students may find themselves working on projects in pairs or small groups, participating in large group discussions or listening to videos or computer-based training or assessments.

With the shift in learning methods, more and more flexibility is required in remote microphone technology. Anyone who has spent time in a classroom where small group work is taking place will know that the need for an improved signal-to-noise ratio is still real. The MM2+ offers a flexible and affordable remote microphone solution for recipients of Baha® users. Consider the following classroom uses for the

MM2+: 

  • Traditional: Give the MM2+ to the teacher for an effortless and direct connection between the teacher’s voice and the student’s Cochlear™ Baha 5 Sound Processor.
  • Conference mode: Switch the MM2+ into conference mode by laying it horizontally on the table during small group activities.
    Direct audio input: Plug the MM2+ into any external audio source (i.e., smart board, computer or tablet) for a direct connection to classroom technology.
  • Telecoil: Switch the MM2+ into T-coil mode to easily pick up room loops during field trips or assemblies.
  • Europin connection: Attach a universal remote microphone receiver to connect the student to any FM or DM system that is utilized in the classroom.

The best thing about the MM2+ is the ease of use – students can switch modes easily using the button on the back of the device and 2.4 GHz wireless technology means the MM2+ connects directly to the processor without the need for external neck loops or dongles.

Share these videos with your patients to help them connect to the MM2+ on their own:

Visit our website for more information on the Mini Microphone and Mini Microphone 2+.

About our guest authors:

Dr. Clarke is a Professional Education Manager for Cochlear Americas.  She joined Cochlear in 1998 and has been in various Clinical or Learning roles throughout her career at Cochlear. She has been an audiologist since 1992, working with cochlear implants since 1993 and Baha since Cochlear’s acquisition of Entific in 2005. Prior to joining Cochlear, Janet worked at the University of Illinois at Chicago. Janet has her AuD from the University of Florida, and did her undergraduate & graduate degrees at Purdue University.

Amy Donaldson is an Audiologist and Professional Education Manager for Cochlear Americas.  She received her Master’s Degree in Audiology from the State University of New York at Buffalo and her AuD from the University of Florida.  She was privileged to begin her career as a pediatric audiologist and gain extensive clinical experience in implantable hearing devices at the University of Michigan in Ann Arbor and at the Manchester Cochlear Implant Programme in the United Kingdom.  After working for several years as an Educational Audiologist and Technical Support Audiologist in the hearing aid industry, she returned to hearing implants and Cochlear in 2011.

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This material is intended for health professionals. If you are a consumer, 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 read the instructions for use. Not all products are available in all countries. Please contact your local Cochlear representative for product information.

 

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