婴儿人工耳蜗植入 "核 "设备的安全性和早期疗效:多中心研究

IF 2.6 2区 医学 Q1 AUDIOLOGY & SPEECH-LANGUAGE PATHOLOGY
Tal Honigman, Sharon L Cushing, Blake C Papsin, Susan Waltzman, Jennifer Woodard, Sara Neumann, Matthew B Fitzgerald, Karen A Gordon
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引用次数: 0

摘要

这项多中心研究考察了 9 到 11 个月大儿童人工耳蜗植入的安全性和有效性。研究的目的是为儿童人工耳蜗植入候选者的候选资格评估和预后咨询提供实践支持。美国和加拿大的五家人工耳蜗植入中心对 9-11 个月大时植入科利耳公司设备的儿童的临床病历数据进行了分析。研究纳入了在 2012 年 1 月 1 日至 2017 年 12 月 31 日期间(队列 1,n = 83)或 2018 年 1 月 1 日至 2020 年 5 月 15 日期间(队列 2,n = 50)植入一个或两个 Nucleus 设备的两个队列的数据。对植入后两年内的主要不良事件(需要再次手术/住院治疗)和轻微不良事件(仅通过药物治疗或接受预期疗程治疗,不需要手术或住院治疗)进行监测,并收集听阈测量结果以及家长对 IT-MAIS 和 LittlEARS 问卷的报告。结果显示,在 41 名儿童和 227 只植入耳朵(26%)中发生了 60 起不良事件,其中 11 名儿童发生了 14 起重大事件;所有事件都是暂时性的,并已得到解决。所有结果均显示,使用人工耳蜗可改善听力。研究结果表明,人工耳蜗植入术对婴儿是安全的,而且婴儿明显受益于人工耳蜗植入术,包括听力提高和听力发育。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Safety and Early Outcomes of Cochlear Implantation of Nucleus Devices in Infants: A Multi-Centre Study.

This multi-center study examined the safety and effectiveness of cochlear implantation of children between 9 and 11 months of age. The intended impact was to support practice regarding candidacy assessment and prognostic counseling of pediatric cochlear implant candidates. Data in the clinical chart of children implanted at 9-11 months of age with Cochlear Ltd devices at five cochlear implant centers in the United States and Canada were included in analyses. The study included data from two cohorts implanted with one or two Nucleus devices during the periods of January 1, 2012-December 31, 2017 (Cohort 1, n = 83) or between January 1, 2018 and May 15, 2020 (Cohort 2, n = 50). Major adverse events (requiring another procedure/hospitalization) and minor adverse events (managed with medication alone or underwent an expected course of treatment that did not require surgery or hospitalization) out to 2 years post-implant were monitored and outcomes measured by audiometric thresholds and parent-reports on the IT-MAIS and LittlEARS questionnaires were collected. Results revealed 60 adverse events in 41 children and 227 ears implanted (26%) of which 14 major events occurred in 11 children; all were transitory and resolved. Improved hearing with cochlear implant use was shown in all outcome measures. Findings reveal that the procedure is safe for infants and that they show clear benefits of cochlear implantation including increased audibility and hearing development.

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来源期刊
Trends in Hearing
Trends in Hearing AUDIOLOGY & SPEECH-LANGUAGE PATHOLOGYOTORH-OTORHINOLARYNGOLOGY
CiteScore
4.50
自引率
11.10%
发文量
44
审稿时长
12 weeks
期刊介绍: Trends in Hearing is an open access journal completely dedicated to publishing original research and reviews focusing on human hearing, hearing loss, hearing aids, auditory implants, and aural rehabilitation. Under its former name, Trends in Amplification, the journal established itself as a forum for concise explorations of all areas of translational hearing research by leaders in the field. Trends in Hearing has now expanded its focus to include original research articles, with the goal of becoming the premier venue for research related to human hearing and hearing loss.
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