评估 LISTENT LCI-20PI 人工耳蜗对语前聋儿童的安全性和有效性

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research Pub Date : 2024-09-15 DOI:10.1016/j.ijporl.2024.112109

Qiang Du , Zengjun Sun , Weijia Kong , Hao Wu , Yun Li , Chunfu Dai

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引用次数: 0

摘要

目的这项前瞻性多中心临床试验旨在评估新型人工耳蜗（CI）系统 LISTENT LCI-20PI 装置在语前聋儿童（6 岁）中的安全性和有效性。设计为 70 名语前聋儿童（6 岁）植入了 LCI-20PI CI 系统。植入时的中位年龄（四分位数间距）为 3 岁（2-4 岁）。LCI-20PI 装置的状态通过 CI 装置测试和装配进行评估，包括测量电诱发复合动作电位 (ECAP)、电极阻抗、主观阈值（T 级）和主观舒适度（C 级）。在为期一年的随访中，对设备的安全性和有效性进行了评估。临床试验注册号为 ChiCTR2200067092。结果92.8%（64/70）的受试者在术中成功测量了电动电势，94.3%（66/70）的受试者在设备激活时成功测量了电动电势。大多数阻抗（99.7%）在 0.7-20 千欧的正常范围内。在激活后 12 个月的测试中，有意义听觉整合量表/婴幼儿有意义听觉整合量表（MAIS/IT-MAIS）的中位数（四分位数间距）为 95%（85%-97.5%）。在激活后 12 个月的测试中，3-6 岁儿童近集单音节词识别得分（MRS）和双音节词识别得分（DRS）的中位数（四分位数间距）分别为 86% (77%-97%) 和 90% (70%-100%)。对于舌前失聪儿童来说，这种 CI 系统是一种经济有效的选择。

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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.

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来源期刊

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

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.