FDA Restrictions Recommended to Change Implant Age from 12 to 7 Months by Researchers

The Food and Drug Administration (FDA) does not specifically test on humans but rather makes recommendations concerning when something is okay to be tested on humans.  When they “approve” a product or process, they have done a very general assessment to determine that the benefits involved outweigh the risks associated with the product or process. If  someone conducts an experiment, study or process that is not FDA-approved, it is not illegal but rather, is not recommended. The Ann & Robert H. Lurie Children's Hospital of Chicago, Illinois, has claimed that there exists evidence that children implanted prior to 12 months show an affinity to learning spoken language, and are more likely to develop it as their primary form of communication, and do so more rapidly than those implanted at a more advanced age.

FDA approved babies older than 12 months to for implantation, as quoted, “The FDA first approved cochlear implants in the mid-1980s to treat hearing loss in adults. Since 2000, cochlear implants have been FDA-approved for use in eligible children beginning at 12 months of age. “(NIDCD)  

The Lurie Children's Hospital’s claim was reviewed by researchers who assessed 219 children who underwent cochlear implantation before they were 3 years old, including a group of 39 who were implanted at younger than 12 months of age.

“The study, expected to open later in 2019, has the potential to expand Food and Drug Administration (FDA) labeling for cochlear implantation to children as young as age 7 months of age.” (Lurie, 2019)

Another study which was published February 3, 2018, stated that out of 17 babies implanted prior to 12 months (in which 3 were bilaterally implanted, both ears) “had no complications”. In this same study, they stated that they had a hard time finding “subjects” due to FDA restrictions of 12 months for infants, largely due to insurance coverage and the appropriate rehabilitation requirements. (NCBI - Miyamoto et al, 2018)

Joy Maisel, an ASL/Bilingual Curriculum Specialist at California School for the Deaf, Riverside (CSDR) posted an article by Science Daily highlighting the Lurie Children’s Hospital’s study with the following comment.

“This article is biased because it lacks precise data on outcomes of Deaf babies and toddlers. Dr. Ann and Robert Lurie from Children's Hospital of Chicago claimed that public policy for cochlear implanting ought to be allowed for Deaf babies under 12 months old due to new evident finding with their 219 patients. It revealed that 39 out of 219 were implanted prior to 12 months old which is illegal. Honestly their argument in this article is invalid but I know many readers will fall for its claim. This is so injustice for Deaf babies and children! We need tactics to prevent medical-specialized people from spreading misinformation about the success of early cochlear implants for Deaf babies and toddlers.”

The statement released by the Lurie Children’s Hospital calling for a public policy change outrages professionals who believe strongly in ASL being a valuable language for children. Their stance is that, “[The reason] Experts urge early cochlear implantation of deaf infants as a public policy priority,” is because it would remove any need for sign language and supposedly “liberate” children from the undue burdens of not being able to communicate with their families.