Cochlear Implantation in Infants: Evidence of Safety

Abstract

The aim of this study was to investigate surgical, anesthetic, and device-related complications associated with cochlear implantation (CI) in children younger than 1 year of age. This was a multicenter, retrospective chart review of all children with severe-to-profound sensorineural hearing loss who underwent cochlear implantation with a Cochlear Nucleus Implant System before 1 year of age. Endpoints included perioperative course, major and minor surgical, anesthetic and device-related complications, and 30-day readmission rates. One hundred thirty-six infants (242 ears) met criteria. The mean age at implantation was 9.4 months (standard deviation 1.8). Six-month follow-up was reported in all patients. There were no major anesthetic or device-related complications. Adverse events were reported in 34 of implanted ears (14%; 7 major, 27 minor). Sixteen adverse events occurred ≤30 days of surgery, and 18 occurred >30 days of surgery. The 30-day readmission rate was 1.5%. The rate of adverse events did not correlate with preexisting medical comorbidities or duration under anesthesia. There was no significant difference detected in complication rate for patients younger than 9 months of age versus those 9 to 11 months of age. This study demonstrates the safety of CI surgery in infants and supports reducing the indication for cochlear implantation to younger than 1 year of age for children with bilateral, profound sensorineural hearing loss obtaining a Cochlear Nucleus Implant System.

Auditory Outcomes in Children Who Undergo Cochlear Implantation Before 12 Months of Age: A Systematic Review

“…38,39 Respiratory complications of laryngospasm, bronchospasm, and aspiration are important to monitor as part of pediatric perioperative care. 40 Surgical complications may include skin erythema, flap necrosis, CSF leak, facial nerve palsy, and device migration, [41][42][43][44][45] as recently systemically reviewed. 6 In the 17 studies included in the present systematic review, surgical complications were disclosed by 8 studies, which included a 0 to 6.6% rate of complications.…”

Task force Guideline of Brazilian Society of Otology – hearing loss in children – Part II — Treatment

“…There may be minor (e.g., superficial skin infection, hematoma) or major (e.g., device malfunction requiring revision surgery, facial nerve paralysis, need for device explantation) postoperative complications. 28 Overall, complication rates reported in the literature range widely from 1% to 5% for major complications and from 4.5% to 15% for minor complications. 29 …”

Cochlear implant-specific risks should be considered, when assessing the quality of life of children and adolescents with hearing loss and cochlear implants–not just cochlear implant-specific benefits–Perspective

“…There is consensus that cochlear implants are largely safe across all age groups with congenital and acquired hearing loss, even for very young children ( Rajan et al, 2018 ; Uecker et al, 2019 ; Sharma et al, 2020 ; Deep et al, 2021 ; Naik et al, 2021 ; Purcell et al, 2021 ). The survival rates for cochlear implants are as follows [ Lane et al (2019) : 10-year cumulative survival rates 97.2%; Chen et al (2022) : 10-year rate 96.8%, 20-year rate 96.7%].…”

“…The most often observed reasons for surgery due to medical complications 4 are device infection and mastoiditis [e.g., Vila et al (2017) : 3.9% for device infections, Nisenbaum et al (2020) : 3.7% for device infections and mastoiditis, Deep et al (2021) : 0.8% “concern for device infection,” 1.2% mastoiditis]. Most pediatric infections occur within 180 days after surgery ( Lander et al, 2020 ).…”