Cochlear Implants New from Cochlear Nucleus
by Cochlear Guest Author

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

March 19, 2020
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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.

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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Expert opinion: Kanso® 2 Sound Processor first impressions

October 15, 2020

By Allison M. Biever, AuD, CCC-A, Rocky Mountain Ear Center

Background

I have been involved in the cochlear implant field for 28 years.  How fulfilling it is to be a part of someone’s hearing journey! I was initially drawn to the field of Speech and Language Pathology and enrolled in the master’s program at CU Boulder in 1989.  After switching majors, it was natural that audiology would have a special place for me, since I was raised by a mother who was born with moderate-to-severe sensorineural hearing loss. 

Why off-the-ear?

Kanso 2

During the COVID-19 pandemic, patients have frequently complained about how hard it is to keep their behind-the-ear processor on when they are also wearing a mask.  One of my cochlear implant patients wears her Nucleus® 7 Sound Processor, the bow of her eyeglasses, a mask and an oxygen tube behind her ear.  She told me, “There isn’t enough room for everything I have to wear behind my ear!”. Having an off-the-ear option for cochlear implant recipients is a big deal. 

Patients who have had a sudden hearing loss and have never had to wear a hearing aid are often very uncomfortable with the feel of something behind the ear.  Some patients have malformed pinnas or pinnas that are close to their heads, making a behind-the-ear sound processor a non-viable option.  Cochlear implant recipients who have tried both a behind-the-ear processor and an off-the-ear option will frequently tell me that the off-the-ear option is considerably more comfortable. 

Initial experience with Kanso® 2 Sound Processor

In mid-July, I was invited to participate in a controlled market release of the Kanso 2 Sound Processor. This amazing sound processor has already changed the lives of the recipients I have been seeing in our clinic.  At activation, I have been fitting both the Nucleus® 7 Sound Processor and the Kanso 2 Sound Processor to our newly implanted recipients.  Our activations are typically conducted a few weeks after surgery. Almost half of the patients returned for their follow-up visits two weeks later wearing the Kanso 2 Sound Processor.  The patients reported it was more comfortable to wear and at two weeks device retention was not an issue.

The Kanso 2 Sound Processor is the diameter of a “Loonie”, which is the Canadian one-dollar coin.  Unlike the first generation Kanso Sound Processor, Kanso 2 Sound Processor is rechargeable and can be controlled from a smartphone+ so that changes can be made to improve auditory performance if needed.  The recipient can check battery life, change volume, master volume, bass, treble or sensitivity.  Recipients can change programs or initiate streaming to an accessory simply by manipulating the app on their smartphone.+ 

Advanced connectivity and beyond

Additionally, recipients who have compatible Apple® or Android™ devices can stream directly to their Kanso 2 Sound Processor, creating an environment for easier phone conversations. Although the technology is similar between the Nucleus 7 Sound Processor and the Kanso 2 Sound Processor, more patients are finding ease of charging the device, ease of putting the device on and overall comfort to be superior with Kanso 2 Sound Processor.  I have also fit several elderly adults with fine motor difficulties and vision deficits who have reported ease of use. 

On average, the Kanso 2 Sound Processor requires less time for counseling because there are fewer parts to manipulate and discuss with the newly-activated recipient.  The entire processor can be placed in a charging case each night for ease of charging.

Smart has never been so simple

One of my favorite features of the Kanso 2 Sound Processor is the “buttonless” design.  Frequently, when patients are given multiple programs, they will inadvertently touch the button on their sound processor and change the program without being aware they have made a change. The simplicity of the Kanso 2 Sound Processor is spectacular!  The recipient can just tap the processor three times to turn it off and twice to turn it on.  I love that it has become so incredible easy for recipients to use.  If I had to choose one processor to use for many of my patients, I would choose the Kanso 2 Sound Processor because of its simplicity.

To learn more about Cochlear’s latest innovations please view this webinar and read this interview.

About the author: Dr. Allison Biever received her bachelor’s degree from the University of Alberta in 1989 and her master’s degree in Audiology at the University of Colorado in 1992, after which time she worked as a fellow in the first cochlear implant program in Colorado. In 2005 she received her Au.D. from Central Michigan University, completing a doctoral thesis that examined the impact of residual hearing on cochlear implantation in children.

Her focus at the Rocky Mountain Ear Center has been helping people regain their hearing through the miraculous technology of cochlear implants. She was awarded the LaFawn Biddle Award and the Hands & Voices Families First Award for her outstanding service to the deaf and hard of hearing community. In addition to her work in the clinic, she is also a prominent researcher in the field of cochlear implants, an instructor for Institute for Cochlear Implant Training (ICIT) and is on the board for the Listen Foundation. Allison enjoys hiking and spending time with her husband and three daughters. She is also an avid runner and Boston Marathon participant.

+The Cochlear Kanso 2 Sound Processor, Nucleus 7 Sound Processor and Nucleus Smart App are compatible with Apple and Android devices, for compatibility information visit www.cochlear.com/compatibility

Apple 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.

Dr. James Connor Sullivan

Professional perspective: Hear from an AuD and recipient on best practices

February 4, 2021

James Connor Sullivan, AuD, CCC-A, F-AAA, discusses his experience as an audiologist and recipient, as well as the future of the cochlear implant industry.

How did your experience as a recipient draw you to the field of audiology?

Dr. Sullivan: As a child, my family always raised their kids that they would have to go to college after graduating high school. As the only person with hearing loss in my family, I was treated no differently. I went through all of my grade school with bilateral hearing aids, and it wasn’t until college that I became a candidate for a cochlear implant.

Prior to getting a cochlear implant, I actually never wanted to be an audiologist. When I was in high school, I always thought I wanted to work in a theater program working behind the scenes as a lighting technician, so I enrolled into a selective theater program in Oklahoma. It was during my first semester of my undergraduate program that I had a pretty significant hearing fluctuation, making me a candidate for a cochlear implant.

As an avid researcher of everything technology, I turned to the web and anything else I could get my hands on to get any information I could about the cochlear implant process, trying to figure out “what a cochlear implant sounds like.” It very quickly became apparent to me that getting good, reliable and accurate information for young adults about cochlear implants is very difficult.

Most young adults with hearing loss are in an awkward stage of their life (for many reasons). Most young adults are trying to figure out their financial situations, career goals, health insurance coverage, how to pay for hearing technology as they are losing coverage, all in the midst of possibly transitioning out of their pediatric audiology clinic and into their adult audiology clinic with a new provider.

I was young, broke, unhappy with my major as a freshman, unable to afford healthcare or new hearing aids, and my hearing had a pretty significant shift in my hearing and word understanding. As part of the cochlear implant approval process I realized that I had a unique insight that most people rarely get to experience or share with their patients.

The day I got activated with my cochlear implant I changed my major from theater to audiology because CI audiologists get to change our patients’ lives every day. I always knew I wanted to do something that had a true impact in others lives and little did I know how much I’d love getting to do it.

 How has the current global environment changed the way you deliver care?

Dr. Sullivan: COVID-19 has thrown a wrench in 2020. I think that the pandemic has made providers think about each procedure and process, and ensure that what we are doing is beneficial to the patient and to the office as a whole. As part of this review, I believe that we have found some things to increase the efficiency of our clinic to help make a lasting change in the patient experience.

  1. Prior to COVID-19, our clinic utilized primarily paper case histories. We have now moved to all digital, allowing for appropriate triaging of patient appointments and for our clinical assistants to move up appointments as medically indicated.
  2.  As face masks are required in all clinical spaces, we have expanded the use of voice-to-text software throughout our iPads® for our patients with significant hearing loss or language barriers.
  3.  We have added virtual appointments for any and all appointments that have the ability to be conducted virtually, including device selections and counseling appointments.

 How do you empower patients to achieve hearing goals and outcomes?

Dr. Sullivan: We have all of our cochlear implant patients establish care with an auditory verbal therapist to assess their needs and set appropriate goals. From an audiology standpoint, it is important to educate the patient, but not over-educate them on all of the intricacies of their equipment. It is VERY easy to get overwhelmed the first day.

At my activation appointments, I tell the patients that they need to “focus” on three things during their first few days with the device, adding more layers of complexities as I see the patient for their follow-ups.

1.       How to change the battery and put the device on.

2.       Focused listening therapy, at least 20-30 minutes a day.

         My go-to apps are AngelSounds™ and Bring Back the Beat. Later I encourage audiobooks.

3.       Progressing through the progressive MAPs.

I typically set a schedule for when to progress, every two days progress to the next MAP. By the next time I see them they’ll be on the appropriate MAP.

At the end of the day wear time and auditory stimulation is the name of the game. As the patient comes for their follow-ups and they display that they have an appropriate grasp of the first concept, then I’ll add in information like accessories.

Is hearing therapy involved?

Dr. Sullivan: In order to ensure the patient has appropriate access to sound, we always check Ling Sounds during their MAPping to ensure an appropriate MAP has been completed. Once appropriate access to all the Ling Sounds has been established, the patient needs to establish care with hearing therapy.

Hearing therapy is an integral part of our cochlear implant team. As previously mentioned, we have established our patients with our auditory verbal therapist in the area. We also encourage at-home exercises and show them in the clinic to ensure understanding of the tools.

How are outcomes and quality-of-life measured?

Dr. Sullivan: We measure outcomes through the SSQ, the Tinnitus Handicap Inventory (if they have Tinnitus) and the Nijmegen Cochlear Implant Questionnaire. These are administered through an online survey site on an iPad. In addition, we regularly assess our patient’s performance through functional testing with CNC and AzBio (in quiet and in noise as appropriate) testing.

Can you touch on awareness/access to care in the cochlear implant industry?

Dr. Sullivan: It’s no secret that cochlear implants are significantly underutilized by patients who could benefit from them. I think that the 60/60 guideline (Zwolan et al. 2020)1 should really be in every clinician’s mind when conducting any audiological examination.

If a patient has less than or equal to 60% word recognition in either ear, or if their pure tone average is at or less than 60 dB HL for either ear, a clinician should refer the patient for a cochlear implant evaluation. It is important to stress that just because you get evaluated for a cochlear implant, it does not mean you are receiving a cochlear implant. I always look at these appointments as information gathering sessions.

Per Zwolan et al. 2020, if utilized as a screening guideline this screening has a 96% detection rate and a 34% false positive rate.

It is important to educate fellow clinicians, providers in the area and patients about the ever-changing cochlear implant landscape. 

What excites you the most moving forward in the CI industry?

Dr. Sullivan: I’m most excited about the expanded access to this life-changing technology. As previously mentioned, I never would have even considered being an audiologist and now I get to work with cochlear implant patients every day. I’m looking forward to the evolution of cochlear implant processor technology and providing access to patients who otherwise would have never received access to this technology.

For more helpful resources, subscribe to the Cochlear ProNews.

About the author: Dr. Sullivan is an audiologist who works in the Houston area with patients who have hearing loss. Dr. Sullivan, also born with a hearing loss, enjoys using both his personal and professional experiences with his cochlear implant and hearing aid to aid in the treatment of his patients. Dr. Sullivan has presented both nationally and internationally on several topics, including Large Vestibular Aqueduct Syndrome, the disorder that resulted in his hearing loss. He is passionate about using his personal experiences alongside clinical knowledge in audiology to help patients across the lifespan and their families who are impacted by hearing loss.   

References:

  1. Zwolan, Teresa A.; Schvartz-Leyzac, Kara C.; Pleasant, Terrence Development of a 60/60 Guideline for Referring Adults for a Traditional Cochlear Implant Candidacy Evaluation, Otology & Neurotology: April 20, 2020 – Volume Publish Ahead of Print – Issue – doi: 10.1097/MAO.0000000000002664

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