Safety and Early Outcomes of Cochlear Implantation of Nucleus Devices in Infants: A Multi-Centre Study.
Tal Honigman, Sharon L Cushing, Blake C Papsin and 5 others
PMID 38887094WHAT IT FOUND
In infants implanted at 9 to 11 months, aided hearing thresholds improved after surgery, and parent-reported hearing scores rose.
Adverse events occurred in 41 of 134 children, and major and minor events were considered transitory and resolved.
Key findings
01Adverse events were reported in 41 of 134 children, with 14 major events in 11 children.
02After implantation, aided hearing thresholds were better than unaided thresholds.
03Parent-reported hearing scores rose from mean IT-MAIS 6.7 to 29.6 and mean LittlEARS 5.2 to 27.3.
STILL TO COME
How it was doneWhat they foundWhat it means for SLPs
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What it does not show
The study was a retrospective chart review with no comparison group, so it cannot show that the measured changes were caused by implantation. Data were taken from clinical records, and some information could be missing or not reported. Effectiveness outcomes were hearing thresholds and parent questionnaires, not language outcomes. Follow-up was up to 2 years, so it does not show later speech or language outcomes. Cochlear Americas funded the work, and Cochlear Corporation trained sites on the protocol, procedures, data entry system, and good clinical practice. The methods and tables give different Cohort 1 counts, 83 versus 84, and the Results and Discussion give different totals, 134 versus 143. The sample was limited to children implanted between 2012 and May 15, 2020 with Nucleus devices at five centres.
Declared interests
The work was supported by Cochlear Americas. The authors declared no potential conflicts of interest. Cochlear Corporation trained the study sites on the protocol, procedures, data entry system, and good clinical practice.
The easy way to misread this
Do not conclude that cochlear implantation at 9 to 11 months guarantees long-term spoken language outcomes. The study reports hearing thresholds and parent-reported hearing scores through 2 years, not language outcomes, and it had no control group.