How has the new 9 month pediatric indication changed the clinical landscape?
Cochlear implants have been revolutionary in the field of hearing and speech, as they have been deemed the recommended treatment option for children with severe to profound sensorineural hearing loss since 1990.
The FDA approval to lower the age for cochlear implantation from 12 months to 9 months for children with bilateral profound sensorineural hearing loss is a groundbreaking leap towards changing the landscape of early intervention for these children. Clinically, this approval has aided in navigating families (who have elected cochlear implantation) both efficiently and expeditiously to optimal auditory access. It is a timely and imperative difference in a baby’s life, as the earlier intervention period of 9 months provides children with hearing loss the necessary access to sound to develop speech and language comparable to their normal hearing peers. For children whose brains are rapidly developing during their first years of life, this three-month change is a vital part of accessing hearing during a critical window for speech and language development.
In terms of psychosocial implications, the hearing loss journey can be an emotional rollercoaster for families. Since the advent of newborn hearing screenings, identification and diagnosis of profound hearing loss can occur at a mere weeks old during infancy. Families with this diagnosis often undergo a series of evaluations, discouraging hearing aid trials, and speech therapy that can seem futile and disheartening as they are unable to witness their child react to sounds or engage in spoken communication. Prior to the FDA approval, families were spending the first year of their baby’s life traversing this hearing loss journey and awaiting 12 months (at minimum) to witness a reaction to speech and other enriching sounds. The new FDA approval is an essential part of providing families of children with hearing loss the necessary and timely tools needed to succeed.
After many years of knowing that earlier implantation, specifically prior to 12 months, leads to better speech and language outcomes1-2, clinical practice is finally catching up to the evidence! All children are now given the opportunity to hear before their first birthday. As a pediatric audiologist, I am excited to be part of this journey with families and I am hopeful to see what the future brings for these superHEARos!
Click here to learn more about the lowered pediatric indication or watch this course where we hear from Kristin Gravel, AuD who will share a case and provide information about candidacy for our youngest recipients!
- 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.
- 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.
In the United States, the Cochlear Nucleus Implant System is approved for use in children 9 to 24 months of age who have profound sensorineural hearing loss in both ears and demonstrate limited benefit from appropriate hearing aids. Children 2 years of age or older may demonstrate severe to profound hearing loss in both ears.
In Canada, the Cochlear Nucleus Implant System (CI500 and CI600 Series) is approved for use in children 9 to 24 months of age who have profound sensorineural hearing loss in both ears and demonstrate limited benefit from appropriate hearing aids. Children 2 years of age or older may demonstrate severe to profound hearing loss in both ears.
© Cochlear Limited 2021. 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.
This content is meant for professional use. 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. Views expressed are those of the individual. Consult your health professional to determine if you are a candidate for Cochlear technology.