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Thursday, May 21, 2020

FDA Lowers Cochlear Implantation Age to 9 Months
Cochlear Americas has received approval from the U.S. Food and Drug Administration (FDA) to lower the age of cochlear implantation from 12 months to 9 months for children with bilateral, profound sensorineural hearing loss. With abundant research demonstrating the benefits of early cochlear implantation in children with prelingual deafness, this update is an important step toward ensuring that children with hearing loss develop speech and language at a trajectory similar to their peers with normal hearing (Hearing Journal. 2019; 72 [11]:16. doi: 10.1097/01.HJ.0000612572.81490.e2). With U.S. states currently developing strategies to safely reopen and resume elective surgeries amid the COVID-19 pandemic, this FDA approval enables cochlear implant (CI) surgeries for younger children with hearing loss to be prioritized, thereby giving these children access to sound as early as possible.

"As states begin to allow more surgeries, we hope this expanded indication will help hospitals to prioritize pediatric cochlear implant surgeries,” said Patricia Trautwein, MA, AuD, the vice president of product management and marketing at Cochlear Americas, in a press release. "Our hopes are that children get access to hearing technology that will help them obtain age-appropriate speech and language as soon as they can."

Three in 1,000 infants born in the U.S. each year have moderate, severe, or profound hearing loss (AAP, 2020). Additionally, hearing loss is the most common congenital condition in the U.S. 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 (Ear Hear. 2013; 34[5]: 535-552).

Cochlear implants have been FDA-approved for use in children since 1990, with CochlearTM Nucleus® cochlear implants obtaining the first approval. 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 (Int J Aud. 2016; 55:S9-S18.)
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“Pediatric indications have only changed twice in the history of our field, starting with the initial pediatric indication in 1990 and then an update in 2000. While there was extensive existing data to support the safety and effectiveness of lowering the age for pediatric cochlear implantation, supporting data was not in a cohesive format or database,” explained Trautwein.
“Our greatest challenge [in getting the FDA approval] was being able to consolidate all of the existing clinical research and evidence in the published literature and combine this with data from our internal database and databases of clinics from around the world to demonstrate the safety and benefit of earlier cochlear implantation in children,” she told The Hearing Journal. “One of the greatest accomplishments was the partnership with the FDA throughout the planning and review of the evidence that secured the regulatory approval to lower the age of implantation from 12 months to 9 months. Based on the evidence, the benefits associated with early implantation may contribute to permanently closing the gap between children with cochlear implants and their normal-hearing peers for speech, language, psychosocial, and academic outcomes.”
A notable study in Australia, for example, has shown that up to 80 percent of children who received CIs younger than 12 months of age demonstrated receptive vocabulary knowledge within the normal range by school entry, and 81 percent of children who received CIs early attended mainstream schools (Otol Neurotol. 2016 Feb; 37[2]: e82-95).
“It is important for families of children born deaf to have a treatment option that provides access to sound for better hearing, speech, and language outcomes in their life,” said Trautwein.
In the U.S., the CochlearTM 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 CochlearTM Nucleus® Implant models, as well as all models developed in the future by Cochlear.