Related Experiment Video
Updated: Aug 21, 2026
Systematic Hearing Performance Evaluation Process for Adolescents with Cochlear Implantation at Early Ages
Published on: March 24, 2023
Multicenter Study Results on Expanded Indications in Med-EL Pediatric Cochlear Implant Population
Nancy M Young1,2,3, Denise Thomas4, Stephen R Hoff5
1Division of Otolaryngology-Head and Neck Surgery, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, USA.
Insights
MED-EL cochlear implants (CIs) are safe and effective for infants under 12 months and young children with residual hearing. These findings support expanding CIs for pediatric hearing loss.
Area of Science:
- Otolaryngology
- Pediatric Audiology
- Medical Device Technology
Background:
- Pediatric cochlear implantation (CI) is crucial for addressing severe to profound sensorineural hearing loss (SNHL).
- Current indications for pediatric CI may not fully encompass all eligible age groups and hearing profiles.
- Evaluating the safety and efficacy of specific CI systems in younger children and those with residual hearing is essential.
Purpose of the Study:
- To assess the safety and efficacy of MED-EL cochlear implants (CIs) in children younger than 12 months.
- To evaluate the performance of MED-EL CIs in children aged 12-71 months with residual hearing.
Main Methods:
- A multicenter study with prospective and retrospective cohorts.
- Subjects received MED-EL CIs, with safety and efficacy data collected up to 12 months post-activation.
- Primary endpoints included speech recognition/auditory skill development and adverse device effects (ADEs).
Main Results:
- Over 80% of subjects in both prospective and retrospective cohorts met performance goals.
- Efficacy was demonstrated across age groups (<12 months and 12-71 months with residual hearing).
- The retrospective cohort met the primary efficacy endpoint, with a low incidence of serious adverse device effects (<6%).
Conclusions:
- MED-EL CIs are safe and effective for pediatric use in the studied age groups.
- Results support expanding cochlear implant indications for infants aged 7-11 months with SNHL.
- The study advocates for broader CI candidacy for children aged 12-71 months with residual hearing.
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.
