Cochlear Implants
by Cochlear Guest Author

2021 Annual Reliability Report

July 25, 2022
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Cochlear is proud to share our 2021 Annual Reliability Report.


With more than three decades of reporting on reliability, our commitment to you and your patients remains constant as we continue with our history of transparent reporting in compliance with the European Consensus statement and ANSI/AAMI standards.

Coming off of 2022 American Cochlear Implant Alliance conference in Washington DC, specific scientific sessions were centered on reliability and the clinical impacts of reimplantation. Panel discussions focused on clinic experience with recent revision surgeries including development of revision assessment protocols, electrode selection, changes in electrode placement and speech perception outcomes. While it is important to understand the clinical experience and impact to patients, it most important to minimize the incidence of reimplantation through quality and reliable implants.


Cochlear™ Nucleus® Implants continue to demonstrate industry leading reliability over decades – not just the first few years. Our CI22M Implants, first introduced in 1985, have set the industry benchmark and show a greater than 90% cumulative survival rate as we approach 35 years since the first implants. We continued our commitment to quality with the CI24M implants, first introduced in 1997, that show 96.0% cumulative survival rate within 25 years. Our focus on long-term reliability is allowing our recipients implanted more than 30 years ago to engage in the world around them in ways they did not imagine; taking advantage of the latest smart sound processing technology, engaging with others through wireless streaming with their compatible* devices and taking advantage of remote care.


The hearing a cochlear implant provides is life-changing for both your patients and their family and friends. Your patients look to you for guidance when it comes to the facts about short- and long-term reliability. For all the latest information please take time to review our reports and understand the differences between manufacturers because without long-term reliability, everything else is a compromise.

Sincerely,
Lisa Aubert
President, Cochlear Americas

Read the 2021 Annual Reliability Report here!

For complete smartphone compatibility information, please visit www.cochlear.com/compatibility

  1. Cochlear Limited. D1932780 V1 2021-03. Cochlear Nucleus System Reliability Report Volume 20, December 2021.
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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pediatric cochlear implant

Cochlear receives FDA approval to lower the age of pediatric cochlear implantation to 9 months

March 19, 2020

Approval underscores necessity of earlier cochlear implantation for better hearing, speech and language outcomes in children born deaf

By Renee Oehlerking, Senior Public Relations Manager – Cochlear Americas

Centennial, Colo. (March 18, 2020) — Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, obtained U.S. Food and Drug Administration (FDA) approval to lower the age of cochlear implantation from 12 months to 9 months for children with bilateral, profound sensorineural hearing loss. This approval ensures children 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.

Cochlear implants have been FDA approved for use in children since 1990 with CochlearTM Nucleus® Implants obtaining the first approval. Decades of research and current surgical and clinical practice underscore the efficacy of earlier implantation to achieve their personal best language and speech outcomes.1-13 The research and support in practice by trained hearing health professionals provided the foundation to approve the indication be lowered to 9 months, along with the considerable developments in technology and evolving speech coding strategies in modern day cochlear implant devices.

“Cochlear implants are one of the most revolutionary and effective modern-day implantable solutions that can restore hearing to children and adults with significant hearing loss,” said J. Thomas Roland Jr., MD, Co-Director, Cochlear Implant Center, and Chair, Department of Otolaryngology – Head and Neck Surgery, NYU Langone Health. “Through our diligent research and years of treating children with hearing loss, we know the earlier a child receives access to sound the sooner they can develop speech and language that will transform their future. It is important that children born deaf have access to cochlear implants as soon as possible to give them the tools to hear and participate in their life to the fullest extent.”

According to the American Academy of Pediatrics, an estimated three in 1,000 infants are born in the U.S. each year with moderate, severe or profound hearing loss.14 Additionally, hearing loss is the most common congenital condition in the U.S.14 Hearing loss has a major impact on a child’s life, including speech and language development, literacy, mental health, social and cognitive functioning, educational achievement, employment and socio-economic opportunity.3 Research shows that children with a severe-to-profound hearing loss who receive cochlear implants early achieve better speech recognition than children who continue to use hearing aids, underscoring the importance to not delay access to cochlear implants because doing so can have lingering developmental consequences.3,4

“Earlier implantation ultimately provides children with access to critical auditory input that has been proven to enhance their development of speech and language,” said Christine Menapace, MA, Vice President, Clinical Affairs, Cochlear Americas. “We hope this approval changes the pathway and access to care for families who desire cochlear implantation so full advantage can be taken of the critical period of language development in a young child.”

While many early intervention factors contribute to a child succeeding with a cochlear implant, cochlear implants provide improved: auditory awareness of sounds at levels within the normal range of hearing15; speech understanding, sound clarity and language skills15; hearing in noise16; quality of life16; and educational outcomes.17 Up to 80 percent of children who received cochlear implants younger than 12 months of age demonstrate receptive vocabulary knowledge within the normal range by school entry, and 81 percent of children who receive cochlear implants early attend mainstream schools.13,18

“When we got the news that our daughter failed her newborn hearing screening and was diagnosed with profound hearing loss at birth, it gutted us. We had never met a deaf person before our daughter and did not know what life would look like raising a child with hearing loss,” said Christy Keane, mother to Nucleus Cochlear Implant recipient, Charly, and social media influencer focused on motherhood and children with hearing loss. “Thankfully, we had an amazing care team who helped us understand all of the possibilities on this journey, and we decided to have Charly implanted at 10 months of age. Now, nearly 3 years old, Charly receives speech therapy every day in school and we work together at home on her listening and language skills. Thanks to all the early intervention factors we provided her, Charly is on track developmentally and we’re so excited to see what her future will bring.”

In the United States, the Cochlear Nucleus 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 2 years of age or older may demonstrate severe to profound hearing loss bilaterally.* This FDA approval is extended to all current Cochlear Nucleus Implant models, as well as all models developed in the future by Cochlear. Cochlear implants are typically covered for children by Medicaid and most insurance plans.** For more information on implantable hearing solutions for children with hearing loss, visit IWantYouToHear.com. For more clinical information on the longitudinal outcomes of cochlear implantation for children with hearing impairment, visit: www.outcomes.nal.gov.au/key-findings.

About Cochlear Limited (ASX: COH)

Cochlear is the global leader in implantable hearing solutions. The company has a global workforce of more than 4,000 people and invests more than AUD$180 million each year in research and development. Products include cochlear implants, bone conduction implants and acoustic implants, which healthcare professionals use to treat a range of moderate to profound types of hearing loss.

Since 1981, Cochlear has provided more than 600,000 implantable devices, helping people of all ages, in more than 180 countries, to hear.

www.cochlear.com/us

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References

  1. Waltzman SB, Roland JT Jr. Cochlear implantation in children younger than 12 months. Pediatrics. 2005; 116(4): 487-493.
  2. Cuda D, Murri A, Guerzoni L, Fabrizi E, Mariani V. Pre-school children have better spoken language when early implanted. Int J Pediatr Otorhinolaryngol. 2014; 78(8):1327-1331.
  3. Ching T, Dillon H, Marmane V, Hou S, Day J, Seeto M, Crowe K, Street L, Thomson J, Van Buynder P, Zhang V, Wong A, Burns L, Flynn C, Cupples L, Cowan R, Leigh G, Sjahalam-King J and Yeh A. Outcomes of early-and late-identified children at 3 years of age: Findings from a prospective population-based study. Ear Hear. 2013; 34(5): 535-552.
  4. Leigh J, Dettman S, Dowell R. Evidence-based guidelines for recommending cochlear implantation for young children: Audiological criteria and optimizing age at implantation. Int J Aud 2016; 55:S9-S18.
  5. Cosetti M and Roland J. Cochlear implantation in the very young child: issues unique to the under-1 population. Trends Amplif. 2010 Mar; 14(1): 46-57.
  6. Holt R and Svirsky M. An exploratory look at pediatric cochlear implantation: is earliest always best? Ear Hear. 2008 Aug; 29(4):492-511.
  7. Roland J, Cosetti M, Wang K, Immerman S, Waltzman S. Cochlear implantation in the very young child: Long-term safety and efficacy. Laryngoscope. 2009; 119(11): 2205-2210.
  8. Holman MA, Carlson ML, Driscoll CL, Grim KJ, Peterson RS, Sladen DP, Flick RP. Cochlear implantation in children 12 months of age and younger. Otol Neurotol. 2013; 34(2):251-258.
  9. Dettman SJ, Pinder D, Briggs RJ, Dowell RC, Leigh JR. Communication development in children who receive the cochlear implant younger than 12 months: Risks versus benefits. Ear Hear. 2007; 28(2 Suppl):11S-18S.
  10. Ching TY, Dillon H, Day J, Crowe K, Close L, Chisholm K, Hopkins T. Early language outcomes of children with cochlear implants: interim findings of the NAL study on longitudinal outcomes of children with hearing impairment. Cochlear Implants Int. 2009;10 Suppl 1:2832.
  11. Colletti L. Long-term follow-up of infants (4-11 months) fitted with cochlear implants. Acta Otolaryngol. 2009 Apr; 129(4):361-6.
  12. Nicholas J and Geers, A. Spoken language benefits of extending cochlear implant candidacy below 12 months of age. Otol Neurotol. 2013; 34:532-538.
  13. 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): e82-95.
  14. Program to Enhance the Health & Development of Infants and Children (PEHD​IC)​ [Internet]. American Academy of Pediatrics; c2020 [cited 10 Feb 2020]. Available from: https://www.aap.org/en-us/advocacy-and-policy/aap-health-initiatives/PEHDIC/Pages/Early-Hearing-Detection-and-Intervention.aspx. 
  15. Novak MA, Firszt JB, Rotz LA, et al. Cochlear implants in infants and toddlers. Ann Otol Rhino Laryngol Suppl 2000;185:46-49.
  16. Hirschfelder A, Gräbel S, Olze H. The impact of cochlear implantation on quality of life: The role of audiologic performance and variables. Otolaryngol Head Neck Surg. 2008 Mar;138(3): 357-362.
  17. Wyatt JR, Niparko JK, Rothman M, deLissovoy G. Cost Utility of the Multichannel Cochlear Implant in 258 Profoundly Deaf Individuals. Laryngoscope.1996;106:816–821.
  18. Semenov, YR, Yeh, ST, Seshamani, M, Wang, N-Y, Tobey, EA, Eisenberg, LS, Quittner, AL, Frick, KD, Niparko, JK, CDaCI

Investigative Team. Age-Dependent Cost-Utility of Pediatric Cochlear Implantation. Ear Hear. 2013;34(4):402-412.

* In 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 2 years of age or older may demonstrate severe to profound hearing loss bilaterally. In Canada, the cochlear implant system is intended for use in children 12 to 24 months of age who have bilateral profound sensorineural deafness and demonstrate limited benefit from appropriate binaural hearing aids. Children 2 years of age or older may demonstrate severe to profound hearing loss bilaterally.

** Payer coverage policies may not align with new indications. Exceptions for coverage should be sought through the prior authorization process. Contact your insurance company or local Hearing Implant Specialist to determine your eligibility for coverage.

Dr. Roland is an advisor for Cochlear.

Journal Club: Age-Related Changes in Temporal Resolution Revisited: Electrophysiological and Behavioral Findings From Cochlear Implant Users

January 14, 2020

By Mary Beth O’Sullivan, Professional Education Manager, Cochlear Americas

Age-Related Changes in Temporal Resolution Revisited: Electrophysiological and Behavioral Findings From Cochlear Implant Users

Bruna S. S. Mussoi and Carolyn J. Brown

Ear & Hearing (2019) 40, 1328-1344

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 journal article summary.

This month’s Journal Club explores a recent 2019 study, Age-Related Changes in Temporal Resolution Revisited: Electrophysiological and Behavioral Findings From Cochlear Implant Users. Factors such as etiology and duration of deafness are well-documented influences on cochlear implant patient outcomes, but the specific role that aging plays on performance is still being investigated.

Studies have shown that older adults demonstrate similar outcomes as other age groups when testing is conducted in quiet, while performance for testing in noise resulted in significant differences.1,2 These findings could be attributed to peripheral and/or central causes, and the recent publication by Mussoi and Brown adds important details to this body of literature by evaluating aspects of both. 

What did the study investigate?

Goals of the study include to:

  1. Re-examine age-related changes in temporal resolution CI users
  2. Assess the impact of aging on the relationship between temporal resolution, cognition and perception of speech in noise in CI users

Why is this important? 

As cochlear implant clinicians, we are driven by optimizing performance for our patients. Clarifying influential factors helps to ensures best practice for counseling expectations as well as for programming older adults.  The authors point out that our understanding of the affect of aging has relied on data accumulated decades ago and deserve a fresh look with current accepted methodology and technology.

How did they do it? 

Here is your need-to-know: 

  • 20 post-lingually deafened subjects
    • 10 subjects age 18-40 years old
    • 10 subjects age 68-82 years old
  • Native English speakers
  • Cochlear Nucleus® recipients with a minimum of one year of listening experience
  • Full insertion a minimum of 19 active electrodes
  • Cognitive screening score cutoff of 27/30
  • Subjects were tested unilaterally. Bilateral CI recipients utilized the preferred better hearing ear and bimodal listeners removed the contralateral hearing aid.

Peripheral Evoked Potential Recordings: ECAP recordings of auditory nerve function were stimulated with Custom Sound® software and recorded on a mid-array electrode previously identified as a robust option. Auditory nerve function was assessed with varying intervals between a masker and probe stimuli, meaning that the nerve was in different states of recovery. The masker stimuli consisted of either a single pulse (refractory recovery paradigm) or a constant pulse train (pulse train recovery paradigm), adding to the challenge of neural recovery and more closely resembling typical CI use.

Central Evoked Potential Recordings: cortical-evoked responses were recorded using stimuli consisting of two constant pulse trains separated by a gap which varied in duration.

Perceptual Measures: Using the same stimuli as the central electrophysiological recordings, gap detection thresholds were measured by providing three presentations and requiring subjects to choose the option with the different gap interval.  Speech perception was tested via direct audio input via Quick Speech Perception in Noise (Quick SIN). 

Cognitive Measures:  Two tests of processing speed and one test of working memory were utilized.

Results and Discussion3

No significant findings were reported in peripheral or central evoked potential or the perceptual measures components of the study.  All subjects passed stringent criteria with the cognitive screening. The only significant finding was that the speed of processing was slower for the older adults, which is consistent with normative data of the general population. When relationships between the various measures was analyzed, one of the temporal resolution measures were correlated to speech in noise.  Working memory was the only measure that correlated with speech in noise.

Results of this study suggest that the effect of advancing age on temporal resolution is minimal, but changes working memory as we age appear to correlate with poorer performance in noise.  The authors acknowledge the small sample size and the possibility that the stimuli used were not challenging enough to reveal age effects. However, more challenging tasks can may become a test of decreased cognitive abilities.  According to the authors, this is only the second study of its kind in which subjects are all CI recipients.  This could be important criteria in separating the effects of age and hearing impairment. 

The older adult population is a bracket that will continue to grow in numbers and increasing need for hearing implants and successful intervention.  It will be exciting to continue to learn from studies that focus on this area.

Learn more about by accessing the publication and stay tuned for next month’s edition of Journal Club!

About our guest author: Mary Beth O’Sullivan is a Professional Education Manager at Cochlear Americas, creating educational opportunities for cochlear implant professionals using research and best practice guidance.  Mary Beth has been an audiologist for 20 years, working in clinical settings ranging from large university hospitals to private practice prior to dedicating herself to the education side of the field. 

References

1. Forli, F., Lazzerini, F., Fortunato, S., Bruschini, L., Cerrettini, S. (2019). “Cochlear implant in the elederly: Results in terms of speech perception and quality of life,” Audiology & Neurotology, 24, 77-83.

2. Lenarz, M., Sönmez, H., Joseph, G., Büchner, A., Lenarz, T. (2012). “Cochlear Implant Performance in Geriatric Patients,” Laryngoscope. 122, 1361-1365.

3. Mussoi, B. S. S., and Brown, C. J. (2019). “Age-related changes in temporal resolution revisited: Electrophysiological and behavioral findings from cochlear implant users,” Ear & Hearing. 40, 1328-1344.

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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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