CC BY-NC-ND 4.0 · Semin Hear 2021; 42(04): 373-380
DOI: 10.1055/s-0041-1739370
Review Article

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

Lisa R. Park
1   Department of Otolaryngology/Head and Neck Surgery, The University of North Carolina at Chapel Hill, Durham, North Carolina
,
Erika B. Gagnon
1   Department of Otolaryngology/Head and Neck Surgery, The University of North Carolina at Chapel Hill, Durham, North Carolina
,
Kevin D. Brown
1   Department of Otolaryngology/Head and Neck Surgery, The University of North Carolina at Chapel Hill, Durham, North Carolina
› Author Affiliations

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.



Publication History

Publication Date:
09 December 2021 (online)

© 2021. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

Thieme Medical Publishers, Inc.
333 Seventh Avenue, 18th Floor, New York, NY 10001, USA