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

Area of Science:

• Otolaryngology
• Biomedical Engineering
• Pediatric Audiology

Background:

• Field Corrective Actions (FCAs) for HiRes Ultra and Ultra 3D (V1) cochlear implants (CIs) have prompted research into device failures and outcomes.
• Data on pediatric CI recipients affected by FCAs, particularly concerning speech development, remain limited.

Purpose of the Study:

• To investigate the clinical course and speech outcomes of children implanted with FCA-affected cochlear implant devices.
• To characterize the failure rates and revision surgery trends in this pediatric population.

Main Methods:

• Retrospective cohort study of pediatric patients (n=27) with FCA-affected CIs.
• Data collected from March 2017 to January 2020 at a tertiary children's hospital.
• Included CI placement, device monitoring, audiologic evaluation, and revision surgery records.

Main Results:

• High device failure rate (73%) observed in pediatric patients with FCA-affected CIs.
• Most failures (90%) led to revision surgery.
• No significant difference in open-set speech recognition scores before and after revision surgery was noted.

Conclusions:

• Pediatric patients with FCA-affected CIs face a substantial risk of device failure.
• Speech recognition abilities were generally maintained post-revision surgery.
• Close multidisciplinary follow-up and timely revisions may mitigate negative impacts on speech outcomes.