Multicenter Study Results on Expanded Indications in Med‐EL Pediatric Cochlear Implant Population
Nancy M. Young, Denise Thomas, Stephen R. Hoff, Jeffrey D. Carron, Victoria B. Gonzalez, Chrisanda M. Sanchez, Ivette Cejas, Paul W. Bauer, Aimee J. Gross, Margaret E. Richter, Lisa R. Park, Kevin D. BrownABSTRACT
Objectives
To demonstrate safety and efficacy of MED‐EL cochlear implants (CIs) in children aged < 12 months and in children aged 12–71 months with residual hearing.
Methods
This was a multicenter, nonrandomized, single‐subject, repeated‐measures study with prospective ( N = 38; 26 < 12 months of age) and retrospective ( N = 209; 70 < 12 months of age) arms. All subjects received MED‐EL CIs before age 6 and had safety data for analysis. Thirty‐six of 38 prospective and 92 of 209 retrospective subjects had efficacy data available for analysis. Primary efficacy endpoint hypothesized that ≥ 75% of subjects would meet study‐specific performance goals on speech recognition or auditory skill development measures by 12 months post‐activation. Primary safety endpoint was adverse device effects (ADEs).
Results
Twenty‐nine of 36 prospective (80.6%) and 81 of 92 retrospective (88.0%) subjects with 12‐month efficacy data met endpoint performance goals. This included 21 of 25 (84.0%) prospective and 32 of 37 (86.5%) retrospective subjects < 12 months old and 6 of 6 prospective and 30 of 34 (88.2%) retrospective subjects 12–71 months old with residual hearing. Prospective sample size was too small for hypothesis testing, but the retrospective cohort met the primary efficacy endpoint (95% CI: 79.6%, 93.9%; p = 0.002). Nine prospective and 33 retrospective subjects experienced any ADE, including serious ADEs (SADEs) in < 6% of subjects. No unanticipated ADEs.
Conclusion
Results suggest that it is appropriate to expand pediatric CI indications to include children aged 7–11 months with profound sensorineural hearing loss (SNHL) and children aged 12–71 months with residual hearing.
Level of Evidence
3