Regulatory Agencies and Cochlear Implants : Review is Imperative

The FDA has a means to reduce harms done by overreaching claims about linguistic benefits of CIs alone: the black box warning or BBW. BBWs call attention to drugs or devices with serious or life-threatening risks to patients. A prelingually deafened child who is implanted and from whom a sign language is withheld is at risk of linguistic deprivation. CIs must come with a BBW to the effect that the CI is part of a necessary bundle that includes sign language for the child.

Accompanying the BBW with printed guidelines that repeat the BBW and offer information on how to provide the child with a sign language plus resources about how the family can become fluent in a sign language is one way to protect deaf children while FDA review is being conducted. These printed materials should include a cognitive development check list, including language milestones (not simply responses to auditory input) and other cognitive benchmarks. The FDA must define as a priority the development of such a language-milestone list (useful material is found in 22-, and should be reviewed at regular intervals as research provides new information. Parents should be urged to seek close evaluation of their child’s language and cognitive development milestones. These printed materials should outline the responsibilities of parents, medical professionals, educators, and other specialists to attend to the child’s developmental milestones (in both spoken and sign language) as seriously as they do to hearing ability. Advisors of all specialties should review the guidance, including checklist and cautions, with families, who need assertive help and positive support in understanding what is reasonable to expect from CIs and how to enhance their effectiveness.

Author(s): Donna Jo Napoli, Tom Humphries, Gaurav Mathur, Christian Rathmann

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