Cochlear Implants
by Ryan Lopez

Counseling new indications and the importance of early access to sound

December 1, 2020
Share

By Ryan Lopez, Director, Nucleus® Product Management & Marketing at Cochlear Americas

For 20 years, cochlear implants have been indicated in children no younger than 12 months of age. Earlier this year, Cochlear received FDA approval to lower the age of cochlear implantation from 12 months to 9 months for children with bilateral profound sensorineural hearing loss.* This important approval ensures that children who are born deaf have earlier access to a cochlear implant which can provide them with the hearing capabilities to develop speech and language at a trajectory similar to their hearing peers.1-3­

As clinicians, counseling parents and caregivers though the decision-making process to implant their child can be an emotional journey. Confidence in understanding why early implantation in children is so important can help to reinforce the vitality of the counseling process.

Age at intervention has been shown to be highly correlated with longitudinal outcomes. Receiving a cochlear implant early in a child’s life provides a greater chance of realizing personal best speech, social and language skills.1 Early access to sound can allow a child’s speech and language development to be on par with normal-hearing peers, enabling a life of possibilities.2-3

In addition to other imperative information surrounding cochlear implantation in children, the Pediatric Evidence Summary for Cochlear Implants take a retrospective approach to clinical data focused on the importance of early access to sound.

Read the Pediatric Evidence Summary now!

References:

  1. Ching TYC and Dillon H. Major Findings of the LOCHI study on children at 3 years of age and implications for audiological management. Int J Audiol. (2013 Dec); 52 Suppl 2:S65-8. doi: 10.3109/14992027.2013.866339
  2. Dettman SJ, Dowell RC, Choo D, Arnott W, Abrahams Y, Davis A, Dornan D, Leigh J, Constantinescu G, Cowan R, Briggs RJ. Long-term communication outcomes for children receiving cochlear implants younger than 12 months: A multicenter study. Otol Neurotol. (2016 Feb); 37(2):e82–e95. doi: 10.1097/MAO.0000000000000915. Copyright 2016 Wolters Kluwer Health, Inc.
  3. Geers AE and Nicholas JG. Enduring advantages of earlier cochlear implantation for spoken language development. J Speech Lang Hear Res. (2013 Apr); 56(2):643-55. doi:10.1044/1092-4388(2012/11-0347).

*In Canada (for CI500 and CI600 series implants) and the United States, the cochlear implant system is intended for use in children 9 to 24 months of age who have bilateral profound sensorineural deafness and demonstrate limited benefit from appropriate binaural hearing aids. Children two years of age or older may demonstrate severe to profound hearing loss bilaterally.

Related Posts
Dr. Laure Pratesi

Aural rehabilitation in practice with Dr. Pratesi

December 14, 2021

Laura Pratesi, AuD, discusses the importance of aural rehabilitation and how she puts it into practice.

What is the value of aural rehabilitation for your adult patients?

Aural rehabilitation is immensely valuable. I recommend it to patients at just about every stage in their hearing wellness journey. I explain that aural rehab is like “physical therapy for the brain.” Whichever skills the patient wants to strengthen or develop, we create a treatment plan and a goal to work towards. I use certain speech in noise tests (such as the QuickSIN or AzBio), as well as questionnaires such as COSI, APHAB, HHIA, HHIE, as benchmarks, to track their progress. 

Data shows that aural rehab is important for adult patients – how do you implement into practice?

Pre-COVID, we were working on developing a weekly in-person group therapy session. I think that patients can learn so much from each other, knowing there are others in the same boat. Group therapy would also give patients the opportunity to listen to lots of different voices (male and female, accent variations, loud and softer talkers, etc.). COVID-19 certainly changed our plans and brought an additional level of complexity as masks hamper lipreading and distort speech signals while quality degrades over distance. We were not sure how to overcome this. So during this time, I have focused on working with patients individually, and having them complete homework by themselves or with family members. 

At what point in the treatment process do you bring up rehab? For whom?

I bring up aural rehab from just about day one. In private practice, if patients are at my office, it is because they notice they are struggling. They have acknowledged that there is an issue, and they want to get to the bottom of it. I listen carefully to their symptoms and concerns. Even patients whose test results fall into the “normal” range may not be performing as optimally as they would like. For some patients, their challenge may have more to do with auditory processing than anatomy and physiology, but that does not mean that their struggles are not real, and do not need to be addressed. If a patient is in front of me with a complaint, then I will work with them to find a solution to their problem!

How does an aural rehab program impact your practice?

I believe focusing on aural rehabilitation means that our clinic is working to treat the whole person. We cannot just fit a set hearing aids or a cochlear implant and call it a day. When the brain has been deprived of certain sounds (sometimes for decades), it’s going to take time to learn how to hear and process again. I was born with hearing loss myself, and I did not hear much in my left ear for the first 20+ years of my life, until I got a hearing aid. I remember the time it took to get adjusted to hearing my refrigerator humming and my clock ticking. I was about two years into wearing my own hearing aids until I could tolerate them at the full volume recommended for my hearing loss.

Even now, if I switch between old and new technology, or change between hearing aid brands, it takes about 2-3 weeks for my brain to adjust to the differences. It only makes sense that it will take time for others to adjust as well. Factors to consider include the patient’s duration of deafness, pre- or post-lingual on-set of hearing loss (i.e. before or after speech development) and interventions used to date. As a provider, and as someone with hearing loss, I think it’s important we address the person as a whole. Many are seeking better access to sound and greater ease with communication. Why would we not want to try to address those concerns?

How has Cochlear™ CoPilot been integrated into your program?

Cochlear CoPilot has been an effective addition to my aural rehab tool box. It has previously been a challenge to find quality, affordable solutions for my patients. There have been programs that have been discontinued, others that are not cost effective, some that are cumbersome or not intuitive. I love how the lessons build off of each other, and the tasks gradually become more complex. If the beginning tasks are too easy, you can jump ahead. If the exercise is too hard, you can go back and work on the skill set that builds up to it. You can focus on names or numbers or street addresses or whatever. I found the exercises to be applicable to real conversations and real interactions.

How have your patients used and benefited from Cochlear CoPilot?

I think that any kind of listening exercise can be beneficial, but I love that patients can stream directly to their processor/hearing aid, or can turn one side off and work an individual ear at a time. It’s been very easy to get the app downloaded and installed for my patients. I set aside a few minutes of their appointment time to go over and practice some of the first lessons. Everyone has found it very simple and easy to use, and not intimidating at all. My patients like the streaming aspect the most – and that they can do the exercises anywhere at any time. I try to get patients to commit to at least one hour a day of dedicated aural rehab time. Snagging 10-15 minutes here or there, they can accomplish that easily! 

Download Cochlear CoPilot for free from the Apple® App Store®.

About the author:

Laura Pratesi, Au.D. is owner of Citrus Hearing Clinic LLC in Clermont, Florida. Dr. Laura received her Bachelor of Science in Communication and Sciences Disorders with a concentration in Human Development from Auburn University in 2008, and her Doctor of Audiology degree from Auburn University in 2012. During her time at Auburn, she had the opportunity to work in a variety of clinical settings including in a school system, hospital system, VA facility, ENT practice, private practice, and assisted living facilities. She has extensive experience in working with both pediatric and geriatric populations, as well as veterans.

Audiology is not just a profession for Dr. Laura, but also a calling. Diagnosed with a progressive hearing loss at age 5 years, she was first fit with amplification by her classmates while at Auburn University. Having struggled with untreated hearing loss for years while falling into care gaps, Dr. Laura is passionate about proper identification, diagnosis and intervention of hearing and balance disorders for patients of all ages. 

Dr. Laura has been featured as a Woman of the Year for 2020 by Orlando Magazine, a HearStrong Champion, was a part of the Docs with Disabilities campaign by the University of Michigan, and was featured on multiple podcasts, including Orlando Lady Boss. She is a Fellow of the American Academy of Audiology, has her CCC-A from ASHA, is a member of the Academy of Doctors of Audiology, and is a member of the Florida Academy of Audiology. Since April 2021, she has been a member of a FLAA Task Force charged with updating Audiology Statutes in the state of Florida. At her practice, she does contract work for the Veteran’s Administration, the Department of Vocational Rehabilitation, the Lake County School System, and the Social Security Administration. She resides in Central Florida with her husband, their five year old son, four cats, and two hermit crabs. In her free time, she is a volunteer at Clermont First United Methodist Church, and the former Publicity Chair board member of the Moonlight Players community theater (on hiatus due to Covid-19).

For compatibility information visit www.cochlear.com/compatibility

Apple, the Apple logo, Apple Watch, 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.

swimming child

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.

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.