Multicenter Study Results on Expanded Indications in Med-EL Pediatric Cochlear Implant Population.

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.