Pediatric Failure Rates and Speech Outcomes in the HiRes Ultra and Ultra 3D Series Recall.

Abstract

Objective: The recent Field Corrective Action (FCA) for the HiRes Ultra and Ultra 3D (V1) cochlear implants (CIs) triggered much research investigating clinical identification, failure rates, and postrevision outcomes. Pediatric data remain limited, especially with regards to speech outcomes. We aim to characterize the trajectory of children implanted with these devices with specific attention to speech outcomes.

Patients: Retrospective cohort study of pediatric patients with FCA-affected CIs from March 2017 to January 2020 at a tertiary children's hospital.

Interventions: CI placement, device monitoring, audiologic evaluation, revision surgery.

Main outcome measures: CI failure rates, revision surgery rate, speech recognition outcomes.

Results: Forty-one devices were implanted in 27 pediatric patients. Average age at implantation was 4.01 years (range, 0.87-12.75). To date, 30 devices (73%) are known failures with 90% of these having undergone revision surgery. No statically significant difference was noted on open-set speech testing across best prerevision, immediate prerevision, and best postrevision time points. Best postrevision CNC scores had a mean score of 71% ± 26%, n = 16.

Conclusions: Pediatric patients implanted with FCA-affected CI devices have a high risk of device failure. Open-set speech recognition was not significantly different from prerevision to postrevision testing, suggesting preserved speech outcomes. This may be partially attributable to limitations of cohort size and the pediatric population with open-set speech testing. However, we suspect that close follow-up with standardized testing and a low threshold for revision surgery provided by our multidisciplinary team may have mitigated these changes. Postrevision open-set speech testing remains positive for these patients.