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Updated: Dec 10, 2025
06:04
Systematic Hearing Performance Evaluation Process for Adolescents with Cochlear Implantation at Early Ages
Published on: March 24, 2023
668
Global Regulatory Review Needed for Cochlear Implants: A Call for FDA Leadership.
Tom Humphries1, Poorna Kushalnagar2, Gaurav Mathur3
1Education Studies and Department of Communication, University of California at San Diego, La Jolla, CA, USA.
Maternal and Child Health Journal
|September 3, 2020
Summary
Regulatory agencies should review cochlear implant (CI) guidance for prelingually deaf children. Early exposure to both sign and spoken languages is crucial for language development and preventing deprivation.
Area of Science:
- Audiology and Speech-Language Pathology
- Developmental Pediatrics
- Regulatory Science
Background:
- Cochlear implant (CI) approval for prelingually deaf children lacked data on language acquisition and lived experiences.
- Clinical trials did not fully assess risks of linguistic deprivation, particularly with caregiver communication barriers.
Purpose of the Study:
- To advocate for a review of regulatory guidance on cochlear implants for prelingually deaf children.
- To emphasize the critical need for accessible language input during sensitive developmental periods.
Main Methods:
- This position paper utilizes argumentation to support its recommendations.
- Analysis of historical FDA approval processes and current understanding of language acquisition in deaf children.
Main Results:
- Recommendations for regulatory agencies to review CI approval for prelingually deaf children.
- Mandatory warnings on variable CI outcomes and the need for comprehensive language input (spoken and signed).
Conclusions:
- Regulatory agencies should update guidance on cochlear implants based on current evidence.
- Prioritizing both auditory-vocal and visuo-gestural language modalities is essential for optimal child development.
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