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Multicenter Study
. 2024 Jan-Dec:28:23312165241261480.
doi: 10.1177/23312165241261480.

Safety and Early Outcomes of Cochlear Implantation of Nucleus Devices in Infants: A Multi-Centre Study

Tal Honigman  1 , Sharon L Cushing  1   2 , Blake C Papsin  1   2 , Susan Waltzman  3 , Jennifer Woodard  4 , Sara Neumann  5 , Matthew B Fitzgerald  6 , Karen A Gordon  2   7   8
Affiliations
Multicenter Study

Safety and Early Outcomes of Cochlear Implantation of Nucleus Devices in Infants: A Multi-Centre Study

Tal Honigman et al. Trends Hear. 2024 Jan-Dec.

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.

Keywords: IT-MAIS and LittlEARS questionnaires; aided audiogram; children; deafness; early treatment; hearing loss.

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Conflict of interest statement

Declaration of Conflicting InterestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
The numbers of major (top row) and minor (bottom row) adverse events for Cohort 1 (left) and Cohort 2 (right) are reported by implantation type. All were transitory and resolved. Post-operative and ear-related infections/conditions were most common.
Figure 2.
Figure 2.
(A) Unaided pure tone thresholds in the ear to be implanted were in severe to profound hearing loss range. (B) Post-operative cochlear implant aided thresholds measured in the soundfield for bilateral, left, or right cochlear implants were in mild hearing loss range indicating good access to conversational speech.
Figure 3.
Figure 3.
(A) Scores on parent-reported questionnaires of auditory development (IT-MAIS on the left and LittlEARS on the right) were poor pre-implant and improved post-operatively. (B) Change in scores for each child with available data confirmed significant improvement.
See this image and copyright information in PMC

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