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成人人工耳蜗植入患者的非对称听力损失:一项多中心前瞻性临床试验的结果和建议。

Asymmetric Hearing Loss in Adult Cochlear Implant Recipients: Results and Recommendations From a Multisite Prospective Clinical Trial.

机构信息

Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, St. Louis, Missouri, USA.

Department of Psychological and Brain Science, Washington University, St. Louis, Missouri, USA.

出版信息

Ear Hear. 2023;44(5):1140-1156. doi: 10.1097/AUD.0000000000001354. Epub 2023 Apr 5.

Abstract

OBJECTIVE

A multisite clinical trial was conducted to obtain cochlear implant (CI) efficacy data in adults with asymmetric hearing loss (AHL) and establish an evidence-based framework for clinical decision-making regarding CI candidacy, counseling, and assessment tools. Study hypotheses were threefold: (1) 6-month postimplant performance in the poor ear (PE) with a CI will be significantly better than preimplant performance with a hearing aid (HA), (2) 6-month postimplant performance with a CI and HA (bimodal) will be significantly better than preimplant performance with bilateral HAs (Bil HAs), and (3) 6-month postimplant bimodal performance will be significantly better than aided, better ear (BE) performance.

DESIGN

Forty adults with AHL from four, metropolitan CI centers participated. Hearing criteria for the ear to be implanted included (1) pure-tone average (PTA, 0.5, 1, 2 kHz) of >70 dB HL, (2) aided, monosyllabic word score of ≤30%, (3) duration of severe-to-profound hearing loss of ≥6 months, and (4) onset of hearing loss ≥6 years of age. Hearing criteria for the BE included (1) PTA (0.5, 1, 2, 4 kHz) of 40 to 70 dB HL, (2) currently using a HA, (3) aided, word score of >40%, and (4) stable hearing for the previous 1-year period. Speech perception and localization measures, in quiet and in noise, were administered preimplant and at 3-, 6-, 9-, and 12-months postimplant. Preimplant testing was performed in three listening conditions, PE HA, BE HA, and Bil HAs. Postimplant testing was performed in three conditions, CI, BE HA, and bimodal. Outcome factors included age at implantation and length of deafness (LOD) in the PE.

RESULTS

A hierarchical nonlinear analysis predicted significant improvement in the PE by 3 months postimplant versus preimplant for audibility and speech perception with a plateau in performance at approximately 6 months. The model predicted significant improvement in postimplant, bimodal outcomes versus preimplant outcomes (Bil HAs) for all speech perception measures by 3 months. Both age and LOD were predicted to moderate some CI and bimodal outcomes. In contrast with speech perception, localization in quiet and noise was not predicted to improve by 6 months when comparing Bil HAs (preimplant) to bimodal (postimplant) outcomes. However, when participants' preimplant everyday listening condition (BE HA or Bil HAs) was compared with bimodal performance, the model predicted significant improvement by 3 months for localization in quiet and noise. Lastly, BE HA results were stable over time; a generalized linear model analysis revealed bimodal performance was significantly better than performance with a BE HA at all postimplant intervals for most speech perception measures and localization.

CONCLUSIONS

Results revealed significant CI and bimodal benefit for AHL participants by 3-months postimplant, with a plateau in CI and bimodal performance at approximately 6-months postimplant. Results can be used to inform AHL CI candidates and to monitor postimplant performance. On the basis of this and other AHL research, clinicians should consider a CI for individuals with AHL if the PE has a PTA (0.5, 1, 2 kHz) >70 dB HL and a Consonant-Vowel Nucleus-Consonant word score ≤40%. LOD >10 years should not be a contraindication.

摘要

目的

开展了一项多中心临床试验,以获取成人单侧听力损失(AHL)患者的人工耳蜗植入(CI)疗效数据,并为 CI 候选者的临床决策、咨询和评估工具建立一个基于证据的框架。研究假设有三个方面:(1)植入侧(PE)植入后 6 个月的表现将明显优于植入前使用助听器(HA)的表现,(2)植入后 6 个月的 CI 和 HA(双模式)表现将明显优于植入前双侧 HA(Bil HAs)的表现,以及(3)植入后 6 个月的双模式表现将明显优于有辅助设备的健耳(BE)表现。

设计

来自四个大都市 CI 中心的 40 名 AHL 成年人参与了这项研究。植入耳的听力标准包括(1)纯音平均听力(0.5、1、2 kHz)>70 dB HL,(2)使用 HA 时,单音节词得分≤30%,(3)严重至重度听力损失的持续时间≥6 个月,以及(4)听力损失开始时间≥6 岁。BE 的听力标准包括(1)PTA(0.5、1、2、4 kHz)为 40 至 70 dB HL,(2)目前正在使用 HA,(3)使用 HA 时的词得分>40%,以及(4)过去 1 年听力稳定。在植入前和植入后 3、6、9 和 12 个月,分别在安静和噪声环境下进行言语感知和定位测量。植入前测试在三个听力条件下进行,即 PE HA、BE HA 和 Bil HAs。植入后测试在三个条件下进行,即 CI、BE HA 和双模式。结果因素包括植入时的年龄和 PE 聋年限(LOD)。

结果

分层非线性分析预测,与植入前相比,PE 在植入后 3 个月时的可听度和言语感知能力有显著提高,在大约 6 个月时达到平台期。该模型预测,与植入前(Bil HAs)相比,所有言语感知测量的植入后、双模式结果在 3 个月时都有显著改善。年龄和 LOD 都被预测为一些 CI 和双模式结果的调节因素。与言语感知不同,在比较 Bil HAs(植入前)和双模式(植入后)结果时,定位在安静和噪声环境中并没有预测到 6 个月时会有改善。然而,当将参与者的植入前日常听力条件(BE HA 或 Bil HAs)与双模式表现进行比较时,模型预测在安静和噪声环境中定位在 3 个月时会有显著改善。最后,BE HA 的结果是稳定的;广义线性模型分析显示,在大多数言语感知测量和定位方面,双模式性能在所有植入后间隔都明显优于 BE HA 的性能。

结论

结果显示,AHL 参与者在植入后 3 个月时出现了显著的 CI 和双模式获益,大约在植入后 6 个月时达到了 CI 和双模式表现的平台期。结果可用于为 AHL CI 候选者提供信息,并监测植入后的表现。基于这一研究和其他 AHL 研究,对于有 AHL 的患者,如果 PE 的纯音平均听力(0.5、1、2 kHz)>70 dB HL,且辅音-元音-辅音核词得分≤40%,临床医生应考虑为其植入 CI。LOD >10 年不应成为禁忌症。

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