Speech Perception in Noise After Cochlear Implantation for Single-Sided Deafness: A Randomized Clinical Trial.

IF 6 1区 医学 Q1 OTORHINOLARYNGOLOGY JAMA otolaryngology-- head & neck surgery Pub Date : 2025-01-16 DOI:10.1001/jamaoto.2024.4760
Jan A A van Heteren, Anne W Wendrich, Jeroen P M Peters, Wilko Grolman, Robert J Stokroos, Adriana L Smit
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Abstract

Importance: There is a lack of high level of evidence studies comparing the effect of different treatment options for single-sided deafness (SSD).

Objective: To determine the effect of a cochlear implant (CI), bone conduction device (BCD), contralateral routing of signals hearing aid (CROS), and no treatment on speech perception in noise outcomes in patients with SSD.

Design, setting, and participants: In this single-center randomized clinical trial, adult patients with SSD were randomized into 3 groups: CI; a trial period with first a BCD on a headband and then a CROS; or a trial period with first a CROS and then a BCD on a headband. After the trial periods, patients opted for a BCD, CROS, or no treatment. Measurements were completed at baseline and at 3, 6, 12, and 24 months of follow-up. Data were collected from July 2014 to October 2021, and data were analyzed from December 2022 to May 2023.

Interventions: CI, BCD then CROS, or CROS then BCD.

Main outcomes and measures: The primary outcome was the speech reception threshold in noise (SRTn), measured with speech and noise from the front (S0N0), speech directed to the poor ear and noise to the better ear (SpeNbe), and vice versa (SbeNpe). The secondary outcome was disease-specific quality of life (QOL).

Results: Of 120 included patients, 60 (50.0%) were female, and the mean (SD) age at inclusion was 53.0 (12.1) years. At the start of follow-up, 28 patients received a CI, 25 a BCD, 34 a CROS, and 26 chose no treatment. At 24 months, the CI group had significantly better speech perception in noise scores than the BCD group (difference in SRTn: SbeNpe, -4.7 dB; 95% confidence interval, -6.6 to -3.0; SpeNbe, -2.2 dB; 95% confidence interval, -4.6 to -1.1), the CROS group (difference in SRTn: S0N0, -1.3 dB; 95% confidence interval, -1.7 to -0.2; SbeNpe, -5.3 dB; 95% confidence interval, -6.0 to -3.1), and the no treatment group (difference in SRTn: SpeNbe, -6.3 dB; 95% confidence interval, -7.5 to -4.9). Compared with the no treatment group, the BCD and CROS groups showed significantly better (difference in SRTn for SpeNbe, -4.1 dB [95% confidence interval, -5.2 to -1.5] and -4.1 dB [95% confidence interval, -6.1 to -3.3], respectively) or worse (difference for SbeNpe, 4.0 dB [95% confidence interval, 2.6 to 6.2] and 4.6 dB [95% confidence interval, 2.8 to 5.7], respectively) speech perception in noise. Self-reported speech perception abilities were significantly better for the CI group compared with the BCD, CROS, and no treatment groups.

Conclusions and relevance: In this randomized clinical trial, the CI group outperformed the BCD, CROS, and no treatment groups in terms of speech perception in noise and disease-specific QOL in patients with SSD after 24 months of follow-up. These results indicate that patients with SSD can partially regain the advantages of binaural hearing after treatment.

Trial registration: trialregister.nl Identifier: NL4457.

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单侧耳聋人工耳蜗植入后的噪声语音感知:一项随机临床试验。
重要性:目前缺乏高水平的证据研究来比较不同治疗方案对单侧耳聋(SSD)的效果。目的:探讨人工耳蜗(CI)、骨传导装置(BCD)、对侧信号路由助听器(CROS)和不治疗对SSD患者语音感知的影响。设计、环境和参与者:在这项单中心随机临床试验中,成年SSD患者被随机分为3组:CI组;先在头带上戴上BCD,然后戴上CROS,进行一段试验期;或者先试用一段时间,先戴上CROS,然后再戴上BCD。试验结束后,患者选择BCD、crs或不治疗。测量在基线和随访3、6、12和24个月时完成。数据收集时间为2014年7月至2021年10月,分析时间为2022年12月至2023年5月。干预措施:CI, BCD然后cross,或cross然后BCD。主要结果和测量方法:主要结果是语音接收噪声阈值(SRTn),通过语音和噪声从前耳(S0N0)测量,语音指向差耳和噪声指向好耳(SpeNbe),反之亦然(SbeNpe)。次要终点是疾病特异性生活质量(QOL)。结果:纳入的120例患者中,女性60例(50.0%),平均(SD)年龄为53.0(12.1)岁。在随访开始时,28例患者接受了CI, 25例接受了BCD, 34例接受了crs, 26例选择不治疗。在24个月时,CI组在噪音评分上的语音感知明显优于BCD组(SRTn差异:SbeNpe, -4.7 dB;95%置信区间为-6.6 ~ -3.0;SpeNbe, -2.2 dB;95%置信区间,-4.6 ~ -1.1),crs组(SRTn差异:0.05,-1.3 dB;95%置信区间为-1.7 ~ -0.2;SbeNpe, -5.3 dB;95%置信区间,-6.0 ~ -3.1)和未治疗组(SRTn差异:SpeNbe, -6.3 dB;95%置信区间为-7.5 ~ -4.9)。与未治疗组相比,BCD组和CROS组在噪声环境下的语音感知表现明显改善(SpeNbe的SRTn差异为-4.1 dB[95%置信区间,-5.2至-1.5]和-4.1 dB[95%置信区间,-6.1至-3.3])或更差(SbeNpe的SRTn差异为4.0 dB[95%置信区间,2.6至6.2]和4.6 dB[95%置信区间,2.8至5.7])。CI组自我报告的言语感知能力明显优于BCD、crs和无治疗组。结论和相关性:在这项随机临床试验中,经过24个月的随访,CI组在SSD患者的噪音语音感知和疾病特异性生活质量方面优于BCD组,crs组和无治疗组。这些结果表明,SSD患者经过治疗后可以部分恢复双耳听力的优势。试验注册:trialregister。标识符:NL4457。
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来源期刊
CiteScore
9.10
自引率
5.10%
发文量
230
期刊介绍: JAMA Otolaryngology–Head & Neck Surgery is a globally recognized and peer-reviewed medical journal dedicated to providing up-to-date information on diseases affecting the head and neck. It originated in 1925 as Archives of Otolaryngology and currently serves as the official publication for the American Head and Neck Society. As part of the prestigious JAMA Network, a collection of reputable general medical and specialty publications, it ensures the highest standards of research and expertise. Physicians and scientists worldwide rely on JAMA Otolaryngology–Head & Neck Surgery for invaluable insights in this specialized field.
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