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核杂交 S12:多中心临床试验结果。

Nucleus Hybrid S12: Multicenter Clinical Trial Results.

机构信息

Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, Iowa.

Department of Biostatistics, University of Iowa, Iowa City, Iowa.

出版信息

Laryngoscope. 2020 Oct;130(10):E548-E558. doi: 10.1002/lary.28628. Epub 2020 Mar 25.

DOI:10.1002/lary.28628
PMID:32212342
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7728297/
Abstract

OBJECTIVES/HYPOTHESIS: The use of a short 10-mm/10-electrode cochlear implant to preserve low-frequency residual hearing was investigated. This report describes the 12-month outcomes of this multicenter clinical trial.

STUDY DESIGN

Single-subject design.

METHODS

Twenty-eight subjects with low-frequency hearing at or better than 60 dB HL at 500 Hz and severe high-frequency hearing loss were implanted with a Nucleus Hybrid S12 implant in their poorer ear. Speech perception in quiet using Consonant-Nucleus-Consonant (CNC) words and sentences in noise using AzBio sentences was collected pre- and postoperatively at 3, 6, and 12 months. Subjective reporting using the Speech, Spatial, and Qualities of Hearing Scale (SSQ) questionnaire was also collected pre- and postoperatively.

RESULTS

Functional hearing preservation was accomplished in 96% of subjects. At 3 and 6 months, 86% of the 28 subjects had maintained functional hearing. By 12 months, 23 out of 27 subjects (85%) had maintained functional hearing (one subject with functional hearing at 6 months withdrew from the study prior to the 12-month visit). Speech perception results demonstrated that 81% of the participants on CNC words and 77% with AzBio sentences in noise had significant improvements using their everyday listening condition at 12 months compared to preoperative performance with bilateral hearing aids. Furthermore, preoperative to 12 months postoperative subjective ratings showed significant improvements for the SSQ.

CONCLUSIONS

This study demonstrates that a high degree of hearing preservation enabling acoustic-electric hearing and improvement in speech understanding in quiet and in noise can be accomplished using a short-electrode 10-mm cochlear implant.

LEVEL OF EVIDENCE

2c Laryngoscope, 130:E548-E558, 2020.

摘要

目的/假设:研究使用短 10mm/10 电极人工耳蜗植入物保留低频残余听力。本报告描述了这项多中心临床试验的 12 个月结果。

研究设计

单病例设计。

方法

28 名受试者在 500Hz 时低频听力在 60dB HL 或以上,高频听力严重损失,在较差耳植入 Nucleus Hybrid S12 植入物。在术前、术后 3、6 和 12 个月,使用 Consonant-Nucleus-Consonant (CNC) 单词和噪声中的 AzBio 句子收集安静时的语音感知,并使用 Speech, Spatial, and Qualities of Hearing Scale (SSQ) 问卷收集主观报告。

结果

96%的受试者实现了功能性听力保留。在 3 和 6 个月时,28 名受试者中有 86%保持了功能性听力。到 12 个月时,27 名受试者中有 23 名(85%)保持了功能性听力(1 名在 6 个月时有功能性听力的受试者在 12 个月就诊前退出了研究)。语音感知结果表明,在噪声中使用日常听力条件时,81%的 CNC 单词参与者和 77%的 AzBio 句子参与者在 12 个月时的表现与双侧助听器术前表现相比有显著提高。此外,术前到 12 个月术后的 SSQ 主观评分显示出显著改善。

结论

这项研究表明,使用短电极 10mm 人工耳蜗植入物可以实现高度的听力保留,从而实现电声听力和安静及噪声中语音理解的改善。

证据水平

2c Laryngoscope, 130:E548-E558, 2020.

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Otol Neurotol. 2018 Mar;39(3):299-305. doi: 10.1097/MAO.0000000000001691.
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The hearing-impaired patient: what the future holds.听力受损患者:未来的走向
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