The Limitations of FDA Criteria: Inconsistencies with Clinical Practice, Findings, and Adult Criteria as a Barrier to Pediatric Implantation

Abstract

Children require greater access to sound than adults as they are learning to communicate using hearing and spoken language. Yet when it comes to cochlear implant candidacy, currently approved Food and Drug Administration (FDA) criteria for adults are much less restrictive than those for children, allowing for greater levels of residual hearing and aided speech recognition in adults. Cochlear implant guidelines for children have changed very little in the 30 years since cochlear implants have been approved for pediatrics, and this lack of change has proven to be a barrier to implantation. Using evidence-based practice, centers have been providing off-label implantation for children who fall outside of current FDA criteria, including children with more residual hearing, children with single-side deafness younger than 5 years, and infants with bilateral profound loss younger than 9 months. The purpose of this article is to outline how these restrictions impede access to implants for children and describe the evidence supporting cochlear implantation in children who fall outside of current criteria.

Hearing Thresholds, Speech Recognition, and Audibility as Indicators for Modifying Intervention in Children With Hearing Aids

“…The estimate occurred at 72% words correct, with upper confidence interval at 80%; however, the lower confidence interval did not provide a clear estimate, representing uncertainty about which speech recognition in quiet scores would indicate that a child is at risk for language delay. Estimates from this study are relatively high compared with values proposed in other guidelines (Park et al 2021a,b). For instance, the American Cochlear Implant Alliance (ACIA) recommends referral for CI evaluation at < 50% word recognition (Warner-Czyz et al 2022).…”

“…For instance, the American Cochlear Implant Alliance (ACIA) recommends referral for CI evaluation at < 50% word recognition (Warner-Czyz et al 2022). FDA guidelines for pediatric cochlear implantation children are even more conservative, suggesting candidates for CI should have word recognition scores of 30% or less (Park et al 2021a). It should be noted that neither guideline specify listening condition (i.e., quiet or noise; Warner-Czyz et al 2022).…”

“…Currently, there are no formal audiologic guidelines for using metrics of audibility and auditory experience when making decisions about modifying intervention or referral for CI candidacy evaluation (Park et al 2021a,b). Speech audibility can be quantified with (aided) and without (unaided) HAs.…”

“…Many children receive benefit from their HAs, with some children showing performance similar to peers with typical hearing (Fitzpatrick et al 2011, 2012), but some CHH do not achieve age-appropriate language levels even when fitted with HAs during the first few months of life (Ching et al 2013; Tomblin et al 2015). Professionals lack evidence to support changes in a child’s intervention (e.g., transitioning from a HA to a cochlear implant [CI]; Wilson et al 2016; Park et al 2021a,b) and how to incorporate audiologic measurements into decisions about these changes (Na et al 2021). This uncertainty may lead to a “failure-based model” of management (Winiger et al 2016), allowing for language deficits to accumulate over time before changes to intervention are made.…”

“…If a child does not precisely meet audiologic or age CI candidacy criteria set forth by the US Food and Drug Administration (FDA), the child can still receive a CI, which is referred to as off-label implantation (Carlson et al 2018). The lack of consistency between government-issued guidelines (e.g., FDA-labeled indications), insurance coverage, research findings, and clinical practice has created ambiguity for professionals and caregivers of CHH as to which children should receive a CI, particularly for children who already use HAs (Park et al 2021a). For instance, the FDA recommends children have severe-to-profound degree of HL to be considered for implantation, despite evidence that children with lesser degrees of HL benefit from CI (for review, see de Kleijn et al 2018) and the increasing regularity of off-label implantation across the United States (Carlson et al 2018; Teagle et al 2019).…”