Evaluation of safety and effectiveness of the LISTENT LCI-20PI cochlear implant in prelingually deafened children.

OBJECTIVES

This prospective multicenter clinical trial was to evaluate the safety and effectiveness of a novel cochlear implant (CI) system, the LISTENT LCI-20PI device in prelingually deafened children (<6 years old).

DESIGN

The LCI-20PI CI system was implanted in 70 prelingually deafened children (<6 years old). The median age (interquartile range) at implantation was 3 years old (2-4 years old). The status of the LCI-20PI devices was evaluated through CI device testing and fitting including measurement of electrically evoked compound action potential (ECAP), electrode impedances, subjective thresholds (T levels), and subjective comfort levels (C levels). The safety and effectiveness of the devices were evaluated during 1-year follow-up. The clinical trial registration number is ChiCTR2200067092.

RESULTS

ECAPs were successfully measured in 92.8% (64/70) recipients intraoperatively and in 94.3% (66/70) recipients during device activation. Most of the impedances (99.7%) were within normal limits of 0.7-20 kOhm. The median (interquartile ranges) Meaningful Auditory Integration Scale/Infant-Toddler Meaningful Auditory Integration Scale (MAIS/IT-MAIS) was 95% (85%-97.5%) at 12-month post-activation testing. Median (interquartile range) close-set monosyllabic-word recognition score (MRS) and disyllabic-word recognition score (DRS) in children 3-6 years old at 12-month post-activation testing were 86% (77%-97%) and 90% (70%-100%), respectively.

CONCLUSIONS

The new developed LCI-20PI CI device proved safe and effective in prelingually deafened children (<6 years old) in the clinical trial. This CI system could be a cost-effective alternative for prelingually deafened children.