Advanced Management of Complex Cases: Children with Multiple Medical Conditions

Cochlear implantation was introduced in the United States as a viable treatment for hearing loss in the 1980s. Originally, the anticipated benefits were awareness of sound and enhancement of speech reading. Therefore, the early candidacy guidelines were very strict. There were concerns that the benefit from a cochlear implant would be limited or potentially be very difficult to measure, so the industry was conservative about who it considered for an implant. Original FDA GuidelinesAt the time of the original Food and Drug Administration (FDA) guidelines for the pediatric clinical trials, children 24 months of age and older were considered.

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