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成年单侧耳聋人工耳蜗植入者的临床结果超过5%的入选标准。

Clinical Outcomes for Adult Single-Sided Deafness Cochlear Implantees Exceeding the 5% Candidacy Criterion.

作者信息

Bernstein Joshua G W, Pillion Elicia M, Tolisano Anthony M

机构信息

National Military Audiology and Speech Pathology Center, Walter Reed National Military Medical Center, Bethesda, Maryland, USA.

Deparment of Surgery, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.

出版信息

Ear Hear. 2025;46(2):336-346. doi: 10.1097/AUD.0000000000001578. Epub 2024 Oct 17.

Abstract

OBJECTIVES

While single-sided deafness cochlear implants (SSD-CIs) have now received regulatory approval in the United States, candidate-ear candidacy criteria (no better than 5% word-recognition score) are stricter than for traditional CI candidates (50 to 60% speech recognition, best-aided condition). SSD implantation in our center began before regulatory approval, using a criterion derived from traditional candidacy: 50% consonant-nucleus-consonant (CNC) word-identification score in the candidate ear. A retrospective analysis investigated whether SSD patients exceeding the 5% CNC criterion nevertheless benefitted from a CI as assessed by spatial-hearing tests (speech understanding in noise [SIN] and localization) and by a patient-reported outcome measure quality-of-life instrument validated for patients with CIs.

DESIGN

A retrospective chart review assessed the clinical experience of a single CI center. Subjects consisted of 27 adult CI recipients with SSD (N = 21) or asymmetric hearing loss (AHL; N = 6) implanted since September 2019 with at least 3 months of postoperative follow-up. Patients with revision surgery or simultaneous labyrinthectomy and CI surgery were excluded from the sample. Subjects were divided into 2 groups based on preoperative CNC scores measured under best-aided conditions with a behind-the-ear hearing aid in the sound field at 0.9 m from a front loudspeaker, and the better ear masked using an insert earphone with 45 dB HL speech-weighted noise. The "MEETS" group had preoperative CNC word scores <5%; the "EXCEEDS" group had scores >5%. The clinical protocol also included intelligibility tests using AzBio sentences in the same test conditions as CNC; binaural spatial testing (broadband-noise sound localization, and matrix-sentence speech-reception thresholds in spatially separated noise) using a custom-built 7-speaker array; and the CI Quality of Life (CIQOL) instrument. To evaluate CI benefit, preoperative unaided performance was compared with postoperative binaural (acoustic ear + CI ear) performance at a clinic visit closest to 6 months postsurgery.

RESULTS

Of 27 SSD-CI recipients, 11 subjects exceeded the 5% preoperative CNC candidacy criterion. Both the MEETS and EXCEEDS groups improved significantly on all 5 primary study outcome measures (CI-alone CNC and AzBio, binaural SIN and sound localization, and CIQOL). The only statistically significant differences observed between the MEETS and EXCEEDS groups were that preoperative CNC and AzBio scores were significantly higher for the EXCEEDS group, as expected given that the groups were defined based on preoperative speech-perception scores in quiet. There were no statistically significant differences between the MEETS and EXCEEDS groups in postoperative scores in any test or in the magnitude of the improvement from preoperative to postoperative assessment.

CONCLUSIONS

SSD- and AHL-CI recipients exceeding the 5% CNC preoperative candidacy criterion significantly improved in CI-alone speech perception, spatial hearing, and subjectively reported CIQOL outcomes and the observed benefits were indistinguishable from SSD- and AHL-CI recipients who met the 5% criterion. A less-restrictive SSD-CI and AHL-CI candidacy criterion should be considered, and larger-scale clinical trials to evaluate CI efficacy using a less-stringent candidate-ear criterion are warranted.

摘要

目的

虽然单侧耳聋人工耳蜗(SSD-CI)现已在美国获得监管批准,但候选耳的入选标准(单词识别得分不高于5%)比传统人工耳蜗候选者(最佳助听条件下语音识别率为50%至60%)更为严格。我们中心在监管批准之前就开始进行SSD植入,采用了源自传统入选标准的一项标准:候选耳中辅音-元音-辅音(CNC)单词识别得分达到50%。一项回顾性分析调查了超过5% CNC标准的SSD患者是否仍能从人工耳蜗中获益,评估方式包括空间听力测试(噪声中的言语理解[SIN]和定位)以及一种经验证适用于人工耳蜗患者的患者报告结局测量生活质量工具。

设计

一项回顾性病历审查评估了单一人工耳蜗中心的临床经验。研究对象包括27名成年人工耳蜗接受者,其中21名为SSD患者,6名为不对称听力损失(AHL)患者,自2019年9月起接受植入,术后至少随访3个月。样本排除了接受翻修手术或同时进行迷路切除术和人工耳蜗手术的患者。根据在最佳助听条件下,使用耳后助听器在距前方扬声器0.9米的声场中测量的术前CNC得分,以及使用插入式耳机加45 dB HL言语加权噪声掩蔽较好耳,将研究对象分为两组。“符合标准”组术前CNC单词得分<5%;“超过标准”组得分>5%。临床方案还包括在与CNC相同的测试条件下使用AzBio句子进行可懂度测试;使用定制的7扬声器阵列进行双耳空间测试(宽带噪声声音定位以及空间分离噪声中的矩阵句子言语接受阈值);以及人工耳蜗生活质量(CIQOL)工具。为评估人工耳蜗的益处,将术前未助听表现与术后最接近6个月门诊时的双耳(听觉耳 + 人工耳蜗耳)表现进行比较。

结果

在27名SSD-CI接受者中,11名受试者超过了5%的术前CNC入选标准。“符合标准”组和“超过标准”组在所有5项主要研究结局指标(人工耳蜗单独使用时的CNC和AzBio、双耳SIN和声音定位以及CIQOL)上均有显著改善。“符合标准”组和“超过标准”组之间观察到的唯一具有统计学意义的差异是,“超过标准”组的术前CNC和AzBio得分显著更高,鉴于两组是根据安静环境下的术前言语感知得分定义的,这是预期之中的。在任何测试的术后得分或从术前到术后评估的改善幅度方面,“符合标准”组和“超过标准”组之间均无统计学意义上的差异。

结论

超过5%术前CNC入选标准的SSD和AHL人工耳蜗接受者在人工耳蜗单独使用时的言语感知、空间听力以及主观报告的CIQOL结局方面有显著改善,并且观察到的益处与符合5%标准的SSD和AHL人工耳蜗接受者没有区别。应考虑采用限制较少的SSD-CI和AHL-CI入选标准,并且有必要开展更大规模的临床试验,以使用不太严格的候选耳标准来评估人工耳蜗的疗效。

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