Cochlear Implants
by Cochlear Guest Author

Cochlear Clinical Quick Tips: Confirming the Auditory Response Intra-Operatively

May 4, 2017
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Providing peace of mind and additional confirmation during cochlear implant surgery with the Nucleus CR220 Intraoperative Remote Assistant.

 

For a new Cochlear™ recipient and their family, knowing that the cochlear implant is functioning as their surgeon and audiologist expected, and that the auditory nerve is responding to stimulation, can be reassuring. For the audiologist and surgeon, knowing that electrode impedances are appropriate, and that AutoNRT® thresholds were measured provides confidence that the surgical procedure was successful. In the past, a laptop with Custom Sound®, a programming pod, and associated cables were required to obtain this information – and it was typically in the purview of the audiologist to take time out of his or her schedule to complete the testing. To address these challenges, Cochlear partnered with surgeons and clinicians to expand the capabilities of the industry-first bidirectional remote assistant to provide this valuable information more quickly, and by anyone in the operating room. Using the CR220 Intraoperative Remote Assistant means obtaining confidence that all electrodes are functioning, and that the auditory nerve is responding to stimulation, has never been easier, faster or more efficient!

 Below is some helpful information to know when working with the CR220 Intraoperative Remote Assistant:

  1. Before using the CR220 in the operating room for the first time, you can learn how it works via the onboard Practice Mode. Simply press and hold the OK button, press the down arrow to highlight Practice Mode, and press OK. Be sure to explore the screens accessed by pressing the right side arrow before, during and after testing. You may wish to turn off the Beeps on Remote under Settings before starting your practice session.
  2. The operating range between the CR220 Remote Assistant and the CP810 processor is up to 6 feet.
  3. For simplicity, the CR220 uses the same intraoperative AutoNRT® parameters as Custom Sound®
    1. Stimulation rate of 250Hz
    2. Measurement starts at 170 current level (CL), after a conditioning stimulus of 230 CL for each electrode.
    3. All 22 intracochlear electrodes are measured starting with Electrode 22, followed by Electrode 1, 11, 6, 16 and so on.

Note: AutoNRT has a high success rate of obtaining threshold NRT (T-NRT) on 93 percent of electrodes, which is better than any other cochlear implant objective measure.1

  1. The CR220 Intraoperative Remote Assistant has clear, simple messages to inform you of any actions you may need to take during testing. Below are just two examples.

          a. If the connection to the internal device is lost, the following will be shown on the CR220’s display screen:

  • A prompt to ‘Reconnect coil to Implant.’ You will have five minutes to reconnect, otherwise the test session will conclude.  If this occurs, you can initiate a new session to collect your data.

          b. After pressing the OK button to pause AutoNRT while it is running you will see:

  • Resume AutoNRT: the device will simply continue testing from where it was paused.
  • View Results: use the arrow keys to see the acquired NRT profile or individual NRT traces.
  • Either Cancel AutoNRT or Finish AutoNRT If you cancel AutoNRT before three electrode measurements are completed, the Auto NRT Cancelled screen will display. Press the OK button to return to the NRT: Electrodes screen to re-start. If you stop AutoNRT after three or more electrode measurements are completed, you will have the option to Finish AutoNRT.

We hope that using the CR220 Intraoperative Remote Assistant enhances your confidence in surgery, reduces your clinical load and complexity, and enhances your clinic efficiency.

If you would like to learn more about the CR220, please visit our one-hour (CEU available) Audiology Online course using the following link:

*van Dijk, B., Botros, A., Battmer, R., Begall, K., Dillier, N., Hey, M., Lai, W., Lenarz, T., Laszig, R., Morsnowski, A., Muller-Deile, J., Psarros, C., Shallop, J., Weber, B., Wesarg, T., Zarowski, A. & Offeciers, E. (2007) . Clinical results of AutoNRT: A completely automatic ECAP recording system for cochlear implants. Ear and Hearing. 28:4, 558-570

©Cochlear Limited 2017. All rights reserved. Hear now. And always and other trademarks and registered trademarks are the property of Cochlear Limited or Cochlear Bone Anchored Solutions AB. The names of actual companies and products mentioned herein may be the trademarks of their respective owners.

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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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Have you had a question in the middle of an appointment about fitting a bimodal patient? We have great news!

The Bimodal Fitting Flow and Bimodal Troubleshooting Guide are available in Custom Sound® Pro under the “Help” tab.

Visit our webpage for additional information regarding bimodal solutions for your patients or cochlear.com/compatibility for all your compatibility questions. 

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Developing innovations with a proven track record of quality

September 27, 2019

By Wade Colburn, Product Manager – Cochlear Implants

Cochlear is committed to the quality of our products and how these products advance hearing performance and quality of life for those affected by hearing loss. With a long-standing track record of reliable implants and durable sound processors2,we focus on delivering quality hearing solutions to meet patient needs.

Since 1982 when Rod Saunders became the first recipient of the Nucleus cochlear implant system3, Cochlear has concentrated on implant and sound processor innovations.  Here’s a glimpse of these innovations over time:

Implant Innovations:

Over the years, implants have improved in many ways, with notable innovations including:

  • Creation of a wide range of electrode variants for varying patient anatomy including the development of perimodiolar electrode arrays with proven performance benefits4,5,6
  • Development of thin and discreet implants reducing the need to drill and improving patient aesthetics
  • Design of an implant with a removable magnet with access to MRI for over 20 years*
  • Enhancement of the design elements and shape to reduce biofilm formation

However, while innovation has been a key focus area, the reliability of the implant over time remains one of the most important features of the Nucleus implant.  But this is nothing new for Cochlear – as those implanted in 1988 with our original implant technology are still able to benefit from our current sound processor offerings and innovations. Yet our commitment to quality means we will continue working to improve the lifespan of each implant generation . We have strived to improve the lifespan of each implant generation so that someone that was implanted in 1988 can still benefit from that original implant technology paired with today’s sound processors.

Processor Innovations:

Sound processor technology has also been transformed over time.  Key innovations of Cochlear sound processors include:

  • Automaticity enhanced sound processing, driving hearing improvement with scene classification and microphone directionality 7
  • Transitioning from body-worn sound processors to the smallest behind-the-ear and off-the-ear sound processors8
  • Chip technologies driving improvement in battery life9, targeted for all-day hearing in a connected world.
  • Direct connectivity of processor to iPhone® and Android™ phones10
  • Datalogs to drive evidence-based clinical decision making
  • Empowerment of patients to monitor and control their device between appointments with the Nucleus Smart App on their smartphone
  • Processors that are water resistant with adventure-proof accessories for hearing whether wet, dry or in between.±

Quite remarkably, Cochlear has designed solutions that make living with a cochlear implant easier, while still maintaining a durable, quality product.  The creation of smaller, smarter and more efficient sound processors has allowed Cochlear to push the cochlear implant industry into a new era. Cochlear promises high quality upgrades that impact performance and lifestyle through backwards compatibility availability.

As the most implanted cochlear implant system with over 395,000 registered systems worldwide2, Cochlear has driven the industry forward with innovations without sacrificing quality.

Historically in the cochlear implant industry, quality has primarily only been measured as implant reliability and all other assessments of quality have been subjective. Reliability reporting has historically been reported based on the European Consensus Statement, but not all manufacturers maintained compliance. 

Cochlear is now excited to also report in compliance with a new standard for the cochlear implant industry – ANSI/AAMI CI86: 2017 Cochlear implant systems: requirements for safety, functional verification, labeling and reliability reporting.  In accordance with this standard, quality of both implants and processors can be assessed. 

For implants, our new reporting measurement will be reported as the Cumulative Removal Percentage (CRP).  This new measurement will look at all implants that have been removed for any reason, including infection. The Profile series, with over 70,000 devices implanted, has a CRP of 1.21%, meaning that 98.79% of implants remain working within 5 years.

For the first time ever, processor reliability is being reported as Failed Component Return Rate (FCRR), which is a percentage calculated by comparing the number of faulty processors returned within a month compared to the cumulative sales of the sound processor over a period of up to 24 months. For Nucleus 7, the average FCRR is .2% over 16 months compared to Nucleus 6, with an average FCRR of .8% average over 24 months.

Check out this example of how the FCRR is calculated (not real numbers):

To learn more about reliability reporting and download our latest reliability report in compliance with ANSI/AAMI CI86.  For more information on the difference between the European Consensus Report and ANSI/AAMI CI86, click here.

About the author: Wade is the Product Manager for Cochlear Implant product portfolio within Cochlear Americas.  Wade’s responsibilities include product positioning and messaging, life-cycle management, new product launches and surgical support and training. Wade has recently joined Cochlear, but comes from an engineering background with the medical device field, including previous otology experience. 

*Cochlear has had MRI access dating back to 1997.  With removal of the magnets, Freedom and Profile series implants are approved for 1.5T and 3.0T MRI’s. The latest implant generation, Profile Plus, allows for 1.5 T and 3.0 T without magnet removal or compression.

±The Nucleus 7 Sound Processor with Aqua+ is water resistant to level IP68 of the International Standard IEC60529. This water protection rating means that the sound processor with the Aqua+ can be continuously submerged under water to a depth of 3 m (9 ft and 9 in) for up to 2 hours. This water protection only applies when you use a Cochlear Standard Rechargeable Battery Module or Cochlear Compact Rechargeable Battery Module.

References:

  1. D1593476. Cochlear Nucleus Implant Reliability Report. Volume 17. December 2018.
  2. D1599672. Cochlear Nucleus Reliability Report (Reporting to ANSI/AAMI CI86 Standard). Volume 1. September 2019.
  3. https://www.cochlear.com/intl/about/company-information/history-of-innovation
  4. Hughes, ML, Abbas, PJ. Electrophysiological channel interaction, electrode pitch ranking, and behavioral threshold in straight versus perimodiolar cochlear implant electrode arrays. J Acoustic Soc Am. 2006; 119(3):1538-47.
  5. Cohen L., Richardson L., Saunders E., Cowan R. Spatial spread of neural excitation in cochlear implant recipients: comparison of improved ECAP method and psychophysical forward masking. Hearing Research. 2003; 179 (1-2):72-87.
  6. Holden LK, Finley CC, Firszt JB, Holden TA, Brenner C, Potts LG, et al. Factors affecting open-set word recognition in adults with cochlear implants. Ear Hear. 2013; 34(3):342-60
  7. Cochlear Limited. D1296247. CLTD 5620 Clinical Evaluation of Nucleus 7 Cochlear Implant System. 2017, Sept; Data on file
  8.  Cochlear Limited. D1190805. CP1000 Processor Size Comparison. 2019, Apr; Data on file
  9. Cochlear Limited. D1140877. Battery Life and Power Consumption Comparison between CP1000, CP900 Series and CP810 Sound Processors. 2017, Sept; Data on file.
  10. Compatibility can be found here: hhtp://www.cochlear.com/compatibility

The Cochlear Nucleus 7 Sound Processor is compatible with iPhone, iPad and iPod touch. Apple, the Apple logo, FaceTime, Made for iPad logo, Made for iPhone logo, Made for iPod logo, iPhone, iPad Pro, iPad Air, iPad mini, iPad 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., registered in the U.S. and other countries.

Android and Google Play are registered trademarks of Google Inc. The Android robot is reproduced or modified from work created and shared by Google and used according to terms described in the Creative Commons 3.0 Attribution License.

The Cochlear Nucleus Smart App is available on App Store and Google Play. For complete smartphone compatibility information, please visit www.cochlear.com/compatibility.

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©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.

 

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