Expanding Possibilities for Pediatrics: A New Indication for the Cochlear™ Nucleus® Implant System
AudiologyOnline: What are the FDA’s new approved indication around use of Cochlear’s technology for children?
Megan Mears: On March 17, 2020 the FDA granted approval to Cochlear Americas to reduce the minimum age of cochlear implantation from 12 months to 9 months of age.
AudiologyOnline: What does this mean for children under 12 months of age, their families and intervention teams?
Megan Mears: This means that children with bilateral profound hearing loss can receive a cochlear implant as young as 9 months old, thereby reducing a prolonged period of auditory deprivation and giving them earlier access to sound. The literature has shown that early intervention is critical to speech and language acquisition for children with hearing loss, and can positively impact developmental and educational milestones.
An example of this is from my colleague, Natasha McDougald, about her daughter. She says, “My daughter received her first cochlear implant before she was one year old. By the time she was in preschool, not only was she singing the Hokey Pokey, but was putting her phalanges (fingers) in and out of the circle! Her receptive language skills exceeded many of the hearing children her age, and we attribute that to her early access to sound from her cochlear implants and the amazing team we worked with tirelessly for hearing and speech therapy. Rose is currently in high school, taking advanced placement biology and planning to pursue a career in genetics – thanks to both early hearing and amazing intervention.”
AudiologyOnline: Is cochlear implantation in 9 to 12 month old children safe?
Megan Mears: Cochlear implantation in children under 12 months old is already standard practice in countries outside the US, and the data in aggregate do not show an increased risk associated with implantation in this younger age group.4-9 In order to support this update to the pediatric indication, Cochlear Americas presented the FDA with a thorough analysis of surgical and anesthesia outcomes which served as critical evidence of the safety of the procedure in 9-11 month olds.4-9
AudiologyOnline What features of a cochlear implant system are important to young children?
Megan Mears: The Nucleus 7 cochlear implant system is designed with little ears in mind, offering the smallest and lightest available sound processors as well as options for off-the-ear wearing and water activities.10 Parents will find the Nucleus Smart App* useful in being able to adjust programs remotely, monitor their child’s wear-time, as well as troubleshoot and find lost processors. Compatibility with FM systems is an important consideration for children as they move into a classroom setting, and Cochlear’s School Resource Center provides fun and engaging listening therapy activities for a variety of ages.
AudiologyOnline Has Cochlear had other recent innovations?
Megan Mears: Cochlear recently updated their electrode portfolio to include the Nucleus® Profile™ Plus implant with an MRI-compatible magnet, providing increased ease and access to care for recipients who need it or who require MRI-imaging in the future. Just this past year, Cochlear launched the new Osia® implanted bone conduction system for individuals with conductive or mixed hearing losses or single-sided deafness.
AudiologyOnline What excites you the most about working with Cochlear?
Megan Mears: The best part of working with Cochlear is being able to actively effect change on issues that matter. Cochlear is continuously assessing the industry landscape, gathering feedback from clinicians and recipients and anticipating future needs. When a company values its customers and its mission in the way that Cochlear does, the prioritization of critical initiatives (such as expanding the pediatric indication) is apparent every day. I am excited that I work for a company that is committed to taking action and delivering an exceptional customer experience.
For more information please read the pediatric indication expansion press release.
References
1. Ching TYC, Dillon H, Leigh G, Cupples L. Learning from the Longitudinal Outcomes of Children with Hearing Impairment (LOCHI) study: summary of 5-year findings and implications. Int J Audiol. (2018 May); 57(sup2).
2. 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:sup2, S6-S68
3. Ching TYC, Dillon H, Button L, Seeto M, Van Buynder P, Marnane V, Cupples, L, Leigh G. Age at Intervention for Permanent Hearing Loss and 5-Year Language Outcomes. Pediatrics. (2017 Sep); 140(3).
4. Holman, C. D. (2013). Cochlear implantation in children 12 months of age and younger. Otol Neurotol, 40(4), 251-258.
5. Birman C. Cochlear implant surgical issues in the very young child. Cochlear Implants Int. 2009; 10 (Suppl 1):19-22.
6. 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.
7. Loundon N, Blanchard M, Roger G, Denoyelle F, Gardedian EN. Medical and surgical complications in Pediatric Cochlear implantation. Arch Otolaryngol Head Neck Surg. 2010; 136(1):12-15.
8. Das Purkayastha PK, Jewell S, James AL, Gordon K, Papsin B. Soft tissue complications after pediatric cochlear implantation in children younger than 12 months. Otol Neurotol. 2011; 32(5):780-783.
9. Broomfield SJ, Murphy J, Emmett S, Wild, D, O’Donoghue GM. Results of a prospective surgical audit of bilateral paediatric cochlear implantation in the UK. Cochlear Implants Int. 2013; 14(S4):S19-S21
10. Cochlear Limited. D1190805. Processor Size Comparison. 2020, Mar; Data on file.
© Cochlear Limited 2020. 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.
Views expressed are those of the individual. Consult your hearing health provider to determine if you are a candidate for Cochlear technology. 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.
*The Cochlear Nucleus Smart App is available on App Store and Google Play. For compatibility information visit www.cochlear.com/compatibility.
In the US, the Osia 2 System is indicated for children 12 and older.
Megan Mears, AuD
Clinical Project Manager, Cochlear Americas
Megan Mears has worked in the field of communication sciences for over 12 years, first as a hospital-based SLP and then as a clinical audiologist before joining Cochlear Americas in 2015 as a clinical project manager. She enjoys partnering with surgeons and audiologists while managing clinical trials, and is particularly passionate about cochlear implant access and awareness in the pediatric population. Megan lives in Colorado and enjoys spending time baking, traveling, and fly fishing.