Related Experiment Video
Updated: Jun 23, 2025
Systematic Hearing Performance Evaluation Process for Adolescents with Cochlear Implantation at Early Ages
Published on: March 24, 2023
Safety and Early Outcomes of Cochlear Implantation of Nucleus Devices in Infants: A Multi-Centre Study
Tal Honigman1, Sharon L Cushing1,2, Blake C Papsin1,2
1Department of Otolaryngology, The Hospital for Sick Children, Toronto, ON, Canada.
Insights
Cochlear implantation is safe and effective for infants aged 9-11 months, showing significant hearing improvements. This study supports early intervention for pediatric cochlear implant candidates.
Area of Science:
- Pediatric Otolaryngology
- Auditory Implants
- Developmental Pediatrics
Background:
- Early diagnosis of hearing loss is crucial for pediatric development.
- Cochlear implantation in infants is increasingly common but requires safety and efficacy data.
- Optimizing candidacy assessment and prognostic counseling for pediatric cochlear implant candidates is essential.
Purpose of the Study:
- To evaluate the safety and effectiveness of cochlear implantation in children aged 9-11 months.
- To provide data supporting candidacy assessment and prognostic counseling for pediatric cochlear implant candidates.
- To analyze adverse events and hearing outcomes in young children receiving cochlear implants.
Main Methods:
- Multi-center retrospective study of children implanted with Cochlear Ltd Nucleus devices between 9-11 months of age.
- Data collected from two cohorts (2012-2017 and 2018-2020) including 133 children and 227 implanted ears.
- Adverse events (major/minor) and hearing outcomes (audiometric thresholds, IT-MAIS, LittlEARS) monitored up to 2 years post-implantation.
Main Results:
- 60 adverse events occurred in 41 children (26%), with 14 major events in 11 children, all transient and resolved.
- All outcome measures demonstrated improved hearing with cochlear implant use.
- Significant gains in audibility and hearing development were observed in the pediatric cohort.
Conclusions:
- Cochlear implantation is a safe procedure for infants aged 9-11 months.
- Pediatric cochlear implantation provides clear benefits, including enhanced audibility and hearing development.
- This study supports early cochlear implantation for eligible infants.
Abstract:
This multi-center study examined the safety and effectiveness of cochlear implantation of children between 9 and 11 months of age. The intended impact was to support practice regarding candidacy assessment and prognostic counseling of pediatric cochlear implant candidates. Data in the clinical chart of children implanted at 9-11 months of age with Cochlear Ltd devices at five cochlear implant centers in the United States and Canada were included in analyses. The study included data from two cohorts implanted with one or two Nucleus devices during the periods of January 1, 2012-December 31, 2017 (Cohort 1, n = 83) or between January 1, 2018 and May 15, 2020 (Cohort 2, n = 50). Major adverse events (requiring another procedure/hospitalization) and minor adverse events (managed with medication alone or underwent an expected course of treatment that did not require surgery or hospitalization) out to 2 years post-implant were monitored and outcomes measured by audiometric thresholds and parent-reports on the IT-MAIS and LittlEARS questionnaires were collected. Results revealed 60 adverse events in 41 children and 227 ears implanted (26%) of which 14 major events occurred in 11 children; all were transitory and resolved. Improved hearing with cochlear implant use was shown in all outcome measures. Findings reveal that the procedure is safe for infants and that they show clear benefits of cochlear implantation including increased audibility and hearing development.
