Qiang Du , Zengjun Sun , Weijia Kong , Hao Wu , Yun Li , Chunfu Dai
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引用次数: 0
Abstract
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.
期刊介绍：
Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance.
Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.
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