Cochlear Implants
by Cochlear Guest Author

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

November 1, 2022
Share

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.

View all posts

Related Posts
woman working at computer

Journal Club: New trends in CI clinical service delivery – Improving clinic efficiency while maintaining recipient outcomes

November 18, 2019

By Dave Catlett, Au.D. – Principal Clinical Training Manager, Cochlear Americas

Presley, R. “Increasing Efficiency While Maintaining Patient Outcomes and Satisfaction: One Clinic’s Approach to a New Service Delivery Model.” Presented at ACIA’s CI2019: 16th Symposium on Cochlear Implants in Children, Hollywood, FL, July 2019

Slager, H. et al. “Artificial Intelligence-Assisted Cochlear Implant Mapping: Implications for Clinic Efficiency and Future Directions.” Poster at ACIA’s CI2019: 16th Symposium on Cochlear Implants in Children Hollywood, FL, July 2019

Zwolan, T. “The Benefits of Using Audiology Assistants in a Cochlear Implant Program.” Presented at ACIA’s CI2019: 16th Symposium on Cochlear Implants in Children Hollywood, FL, July 2019

In today’s busy clinical environment, clinicians who value research-based practice often struggle to keep up with current literature. To help, we’re excited to offer a new ProNews Blog monthly feature – Journal Club!  Each month, rotating guest authors will present a current research-based journal article summary.

This month’s Journal Club explores two podium presentations and one poster presented at the ACIA CI2019: 16th Symposium on Cochlear Implants in Children conference in Hollywood, Florida by audiologists from the University of Michigan and Greater Baltimore Medical Center (GBMC).

What did these clinics investigate?

Each of these investigations explored ways to improve patient access to cochlear implant technology and clinical care including:

  • Use of trained, non-audiologist clinical assistants to supplement provision of testing (particularly for pediatric recipients), counseling and troubleshooting
  • Reduction in audiologist non-billable time and procedures
  • Efficacy of reducing the number of clinical programming appointments in the first year post-activation while preserving recipient performance outcomes and patient satisfaction

Why is this important? 

Despite increased awareness of cochlear implants in the general population and growth in the number of clinics providing cochlear implant services, it has been estimated that only 5% of those who could benefit from a cochlear implant have received one.1,2

Ongoing efforts to educate professionals and the public on the benefits of cochlear implantation, coupled with an aging population and research showing that untreated hearing loss can lead to the acceleration of isolation in the elderly, are intended to increase consideration of CI and guide more potential candidates to clinics for assessment and, if indicated, implantation.3

Increasing clinic capacity to accommodate greater access without sacrificing quality of outcomes or overwhelming clinic schedules is an increasingly-discussed topic, as evidenced by dedicated sessions at recent ACIA meetings focused on service delivery. In light of this, clinics are exploring novel approaches to the provision of quality care for their patients, increasing clinic productivity and reducing non-billable time and services.

How did they do it?

Each presentation described similar challenges seen among CI centers looking to provide quality care in a sustainable way.

  • Access to sound booths for testing and, increasingly, real ear equipment to optimize contralateral hearing aids and/or verify acoustic CI components
  • Busy clinic schedules, particularly the number and length of post-operative programming appointments
  • Less-than-ideal reimbursement, especially given the needed provision of non-billable services like counseling, troubleshooting and email/phone responses
  • Increasing facility scrutiny of audiologist productivity and patient-focused quality of care metrics
  1. Dr. Presley described in detail several practice changes4 that have been implemented in recent years at GBMC including:
  • A pre-operative device counseling workshop to bring CI candidates together for a group session reviewing surgery and vaccination information, realistic expectations, device selection and ordering options. This would also allow candidates to connect with others in similar stages of their implant journey.
  • Development of increased webpage resource links for candidates, including a private Facebook group and manufacturer resources, as well as device counseling and surgical-consent videos to streamline the process and provide consistent information
  • Use of non-audiologist support staff to assist with non-billable activities
    • Use of a clinic-trained ‘CI technician’ for device review, equipment set-up and pairing, externals troubleshooting and to device counseling workshop facilitation
    • Aural rehab therapist who sees recipients two-weeks post-IA and takes on some equipment counseling responsibilities as part of their billable time
    • Administrative assistants trained to provide basic equipment troubleshooting by phone and in clinic
  • Ongoing review and evolution of clinic protocols with a focus on increasing patient empowerment and assessment-based outcomes
  • Reduction over time of programming appointments in the first year post-operatively from eight to five, with no reported impact in patient outcomes or satisfaction

2. Dr. Zwolan described the need for and initiation (in 2016) of a CI Audiology Assistant position at the University of Michigan (UM) implant program.5 The potential responsibilities include:

  • Management of processor upgrade requests and pre-authorizations
  • Maintenance of clinic test equipment, loaner speech processors and hearing aids
  • Assistance with pediatric testing and programming
  • Troubleshooting of hearing aids and CI processors for walk-ins or by telephone

She also detailed CPT coding and reimbursement fee schedules associated with common CI procedures and compared these with average hourly salaries of audiologists versus audiology assistants.

  • According to ZipRecruiter.com, audiology assistants typically make about $34,305 annually (range = $20-60K) 
    • Plus benefits at 31.7% = $45,179 annual, $21.72/hour
  • Average annual salary for audiologists = $75,000 
    • Plus benefits (31.7%) = $98,775 annual, $47.48/hour
  • In an “average” scenario, audiologists cost about $25/hour more than a typical audiology assistant

Dr. Zwolan also provides guidance for developing a return-on-investment (ROI) proposal that clinics can use to facilitate conversations with their facilities, such as tracking current non-billable time spent in clinic to highlight the potential need for audiology assistance and relating that to improvements in patient access, satisfaction and quality of care.

3. Dr. Slager and her colleagues at the UM CI program described their site’s participation in a study seeking to validate the evidence-based clinical tool to assist programming and featuring a streamlined post-operative mapping schedule for adults.6

The study protocol dictated just four programming sessions in the first six months (IA, 1-, 3- and 6-month intervals), compared to UM’s existing clinic protocol at study initiation of six visits in the first six months (two-day IA, 1 week, and 1-, 3- and 6-month intervals).

Performance at the 3- and 6-month intervals was also evaluated in soundfield using CNC words and AzBio sentences at +10 signal-to-noise ratio and then compared with pre-operative scores on those same tests.

Results

At GBMC, monthly group device counseling workshops have reduced non-billable services by 75% (Fig. 1)4, while provided (and billable) clinical services have almost doubled in the past three years (Fig. 2).4

Similarly, the use of audiology assistants at the UM resulted in increased productivity and improved patient access.

In addition, the UM poster noted improvements in CNC word scores for their eight subjects at the 3- and 6-month intervals compared with pre-operative performance. They also reported no subjective changes in clinician-patient relationship with the use of the study’s novel programming procedure and two fewer programming sessions in the first six months post-activation. Based on their study experience, the UM clinic protocol has since changed by removing the Day 2 programming appointment, resulting in increased patient access and improved audiologist productivity.

Discussion

Each of these presentations reveal examples of clinic efforts to increase both patient access and audiologist productivity while maintaining recipient outcomes. These are necessary goals for any-sized CI programming center to remain viable and sustainable providers of excellent clinical care. Individual clinic protocols should be reviewed regularly and, if evidence of potential improvements such as those noted here are seen or desired, adjusted over time to best accommodate the realities of scheduling, billable services and patient-centered outcomes.

Learn  more about this exciting clinical strategy by accessing the presentations and stay tuned for next month’s edition of Journal Club!

References

  1. Blanchfield, B.B., et. Al. (2001). The severely to profoundly hearing-impaired population in the United States: Prevalence estimates and demographics. JAAA. 12, 183-189.
  2. Cochlear internal estimate, recipients data.
  3. Lin FR et al (2013) Hearing loss and cognitive decline in older adults.  JAMA Intern Med, 174(4):293-299
  4. Presley, R. “Increasing Efficiency While Maintaining Patient Outcomes and Satisfaction: One Clinic’s Approach to a New Service Delivery Model.” Presented at ACIA meeting, Hollywood, FL, July 2019
  5. Zwolan, T. “The Benefits of Using Audiology Assistants in a Cochlear Implant Program.” Presented at ACIA meeting, Hollywood, FL, July 2019
  6. Slager, H. et al. “Artificial Intelligence-Assisted Cochlear Implant Mapping: Implications for Clinic Efficiency and Future Directions.” Poster at ACIA meeting, Hollywood, FL, July 2019
woman with bimodal solution using phone

Nucleus® Bimodal Update

June 12, 2018

Hearyourway

More patients can now be bimodally fit than before; including our youngest and oldest patients.  The ReSound Up Smart pediatric hearing aid line, which features True Wireless™ connectivity; is one suite of hearing aids now included in Cochlear’s bimodal solution. Combining a ReSound Up Smart hearing aid with a Kanso® Sound Processor*, for example, can be used for the pediatric patient best-fit in a bimodal configuration.

Bimodal solution Bimodal Solution

For older children and adults who might be interested in Made for Apple® capabilities, using a Nucleus® 7 cochlear implant sound processor with any of the ReSound LiNX 3D or ENZO 3D technology level 7 hearing aids can allow them a premium level of connectivity.  This device pairing is compatible with both the Nucleus® Smart App and the ReSound Smart 3D App, giving parents and recipients access to powerful tools such as Find My Sound Processor and Hearing Tracker.  As always, to further enhance a patient’s hearing in everyday noisy situations, Cochlear’s True Wireless accessories: the Mini Microphone 2+, Phone Clip or TV Streamer are available.

Bimodal Solution

For information on Pairing and Streaming with the Nucleus 7 Smart Bimodal Solution, please download: How to pair and stream a Made for iPhone and True Wireless device with a Cochlear Nucleus 7 Sound Processor and compatible ReSound hearing aids Guide.

For bimodal compatibility information, please download: Cochlear Nucleus System and ReSound hearing aids Wireless Compatibility Guide

Cochlear logo

*SNR-NR,WNR and SCAN are approved for use with any recipient ages 6 years and older who is able to 1) complete objective speech perception testing in quiet and in noise in order to determine and document performance 2) report a preference for different program settings
Cochlear, Custom Sound, Kanso, Hear now. And always, Nucleus, True Wireless and the elliptical logo are either trademarks or registered trademarks of Cochlear Limited.
The Nucleus 7 Sound Processor is compatible with iPhone 8 Plus, iPhone 8, iPhone 7 Plus, iPhone 7, iPhone 6s Plus, iPhone 6s, iPhone 6 Plus, iPhone 6, iPhone SE, iPhone 5s, iPhone 5c, iPhone 5, iPad Pro (12.9-inch), iPad Pro (9.7-inch), iPad Air 2, iPad Air, iPad mini 4, iPad mini 3, iPad mini 2, iPad mini, iPad (4th generation) and iPod touch (6th generation) using iOS 10.0 or later.
Apple, the Apple logo, iPhone,and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc.
ReSound is a trademark of GN Hearing A/S.
Cochlear logo - white

©Cochlear Limited 2024. All rights reserved. ACE, Advance Off-Stylet, AOS, Ardium, AutoNRT, Autosensitivity, Baha, Baha SoftWear, BCDrive, Beam, Bring Back the Beat, Button, Carina, Cochlear, 科利耳, コクレア, 코클리어, Cochlear SoftWear, Contour, コントゥア, Contour Advance, Custom Sound, DermaLock, Freedom, Hear now. And always, Hugfit, Human Design, Hybrid, Invisible Hearing, Kanso, LowPro, MET, MP3000, myCochlear, mySmartSound, NRT, Nucleus, Osia, Outcome Focused Fitting, Off-Stylet, Piezo Power, Profile, Slimline, SmartSound, Softip, SoundArc, True Wireless, the elliptical logo, Vistafix, Whisper, WindShield and Xidium are either trademarks or registered trademarks of the Cochlear group of companies. The names of actual companies and products mentioned herein may be the trademarks of their respective owners.

 

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.

 

Cochlear ProNews is monitored Monday through Friday, excluding some holidays. Questions and inquiries submitted over the weekends or holidays may see a delay in response. For immediate assistance please contact us directly. You are solely responsible for your interactions with other members of our Websites. Cochlear reserves the right, but has no obligation, to monitor disputes or communications between you and other members of our Websites. For a full list of Cochlear’s terms of use, click here.