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单侧聋植入人工耳蜗的益处:来自 House 诊所-南加州大学-加州大学洛杉矶分校临床试验的数据。

Benefits of Cochlear Implantation for Single-Sided Deafness: Data From the House Clinic-University of Southern California-University of California, Los Angeles Clinical Trial.

机构信息

Auditory Implants Department, House Ear Institute, Los Angeles, CA, USA.

Department of Head and Neck Surgery, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.

出版信息

Ear Hear. 2019 Jul/Aug;40(4):766-781. doi: 10.1097/AUD.0000000000000671.

DOI:10.1097/AUD.0000000000000671
PMID:30358655
Abstract

OBJECTIVES

Cochlear implants (CIs) have been shown to benefit patients with single-sided deafness (SSD) in terms of tinnitus reduction, localization, speech understanding, and quality of life (QoL). While previous studies have shown cochlear implantation may benefit SSD patients, it is unclear which point of comparison is most relevant: baseline performance before implantation versus performance with normal-hearing (NH) ear after implantation. In this study, CI outcomes were assessed in SSD patients before and up to 6 mo postactivation. Benefits of cochlear implantation were assessed relative to binaural performance before implantation or relative to performance with the NH ear alone after implantation.

DESIGN

Here, we report data for 10 patients who completed a longitudinal, prospective, Food and Drug Administration-approved study of cochlear implantation for SSD patients. All subjects had severe to profound unilateral hearing loss in one ear and normal hearing in the other ear. All patients were implanted with the MED-EL CONCERTO Flex 28 device. Speech understanding in quiet and in noise, localization, and tinnitus severity (with the CI on or off) were measured before implantation (baseline) and at 1, 3, 6 mo postactivation of the CI processor. Performance was measured with both ears (binaural), the CI ear alone, and the NH ear alone (the CI ear was plugged and muffed). Tinnitus severity, dizziness severity, and QoL were measured using questionnaires administered before implantation and 6 mo postactivation.

RESULTS

Significant CI benefits were observed for tinnitus severity, localization, speech understanding, and QoL. The degree and time course of CI benefit depended on the outcome measure and the reference point. Relative to binaural baseline performance, significant and immediate (1 mo postactivation) CI benefits were observed for tinnitus severity and speech performance in noise, but localization did not significantly improve until 6 mo postactivation; questionnaire data showed significant improvement in QoL 6 mo postactivation. Relative to NH-only performance after implantation, significant and immediate benefits were observed for tinnitus severity and localization; binaural speech understanding in noise did not significantly improve during the 6-mo study period, due to variability in NH-only performance. There were no correlations between behavioral and questionnaire data, except between tinnitus visual analog scale scores at 6 mo postactivation and Tinnitus Functional Index scores at 6 mo postactivation.

CONCLUSIONS

The present behavioral and subjective data suggest that SSD patients greatly benefit from cochlear implantation. However, to fully understand the degree and time course of CI benefit, the outcome measure and point of comparison should be considered. From a clinical perspective, binaural baseline performance is a relevant point of comparison. The lack of correlation between behavioral and questionnaire data suggest that represent independent measures of CI benefit for SSD patients.

摘要

目的

人工耳蜗植入已被证明可改善单侧聋(SSD)患者的耳鸣减轻、定位、言语理解和生活质量(QoL)。虽然先前的研究表明人工耳蜗植入可能使 SSD 患者受益,但目前尚不清楚哪种比较点最相关:植入前的基线表现与植入后正常听力(NH)耳的表现。在这项研究中,在人工耳蜗激活后长达 6 个月的时间内,对 SSD 患者进行了人工耳蜗植入后的评估。将人工耳蜗植入的益处与植入前的双耳表现或植入后 NH 耳的表现进行了比较。

设计

在这里,我们报告了完成一项关于 SSD 患者人工耳蜗植入的纵向、前瞻性、美国食品和药物管理局批准的研究的 10 名患者的数据。所有患者的一只耳朵均有严重至重度单侧听力损失,另一只耳朵听力正常。所有患者均植入 MED-EL CONCERTO Flex 28 设备。在植入前(基线)和人工耳蜗处理器激活后 1、3、6 个月,使用双耳(双耳)、人工耳蜗耳单独和 NH 耳单独(人工耳蜗耳被堵塞和捂住)测量言语理解能力在安静和噪声环境中的理解能力、定位能力和耳鸣严重程度(人工耳蜗开启或关闭)。在植入前和植入后 6 个月使用问卷调查评估耳鸣严重程度、头晕严重程度和生活质量。

结果

观察到耳鸣严重程度、定位、言语理解和生活质量方面的人工耳蜗显著获益。人工耳蜗获益的程度和时间进程取决于测量结果和参考点。与双耳基线表现相比,在人工耳蜗处理器激活后 1 个月即可观察到耳鸣严重程度和噪声环境下言语理解能力的显著和即时(人工耳蜗处理器激活后 1 个月)人工耳蜗获益,但定位能力直到人工耳蜗处理器激活后 6 个月才显著改善;问卷调查数据显示,植入后 6 个月生活质量显著改善。与植入后仅用 NH 耳相比,耳鸣严重程度和定位均有显著和即时的获益;在 6 个月的研究期间,由于 NH 耳的单独表现存在变异性,双耳噪声下言语理解能力并没有显著改善。除了耳鸣视觉模拟量表评分与植入后 6 个月的耳鸣功能指数评分之间存在相关性外,行为和问卷数据之间没有相关性。

结论

本行为和主观数据表明 SSD 患者从人工耳蜗植入中受益匪浅。然而,为了全面了解人工耳蜗获益的程度和时间进程,应考虑测量结果和比较点。从临床角度来看,双耳基线表现是一个相关的比较点。行为和问卷数据之间缺乏相关性表明,它们代表了 SSD 患者人工耳蜗获益的独立测量指标。

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