Department of Otolaryngology/Head and Neck Surgery, University of North Carolina at Chapel Hill, North Carolina, U.S.A.
Laryngoscope. 2013 Oct;123(10):2509-15. doi: 10.1002/lary.23741. Epub 2013 Aug 5.
OBJECTIVES/HYPOTHESIS: To report on single-center data of an FDA-approved clinical trial on the objective benefits of cochlear implantation and subsequent ipsilateral Electric-Acoustic Stimulation (EAS).
Single-center data from a prospective, multicenter clinical trial.
Eighteen subjects completed the 12-month EAS evaluation and were included in this evaluation. Each patient underwent cochlear implantation using a standardized hearing preservation approach. Both hearing preservation and speech perception abilities were evaluated at various intervals. Speech testing included performance measures obtained in quiet (CNC words) and noise (adaptive CUNY protocol) in three listening conditions: hearing aid (HA) alone, cochlear implant (CI) only, and combined ipsilateral EAS.
Various levels of hearing preservation were achieved with cochleostomy and round-window surgical approaches in 17 of the 18 subjects. Mean CNC word scores at the 12-month interval were 14.9 ± 12.1, 45.3 ± 15.4, and 70.7 ± 11.7% correct in the HA only, CI only, and EAS conditions, respectively. Average CUNY scores at 0 dB SNR were 14.6 ± 17.2, 47.1 ± 22.1, and 72.2 ± 21.5 for the three test conditions obtained after 12 months.
Data obtained during this clinical trial correlate well with previous reports. Hearing preservation appears successful in a high number of subjects, and combined EAS offers excellent speech perception abilities in quiet and in noise.
目的/假设:报告 FDA 批准的关于人工耳蜗植入和随后同侧电声刺激(EAS)的客观获益的单中心临床试验数据。
前瞻性、多中心临床试验的单中心数据。
18 名受试者完成了 12 个月的 EAS 评估,并纳入了本次评估。每位患者均采用标准化听力保护方法进行人工耳蜗植入。在不同时间间隔评估听力保护和言语感知能力。言语测试包括在三种听力条件下(助听器单独使用、人工耳蜗单独使用和同侧 EAS 联合使用)在安静环境(CNC 单词)和噪声(适应性 CUNY 协议)中获得的表现测量:助听器单独使用、人工耳蜗单独使用和同侧 EAS 联合使用。
在 18 名受试者中的 17 名中,通过圆窗和耳蜗造口术实现了不同程度的听力保护。在 12 个月的间隔时,仅使用助听器、仅使用人工耳蜗和同侧 EAS 条件下的 CNC 单词得分分别为 14.9 ± 12.1、45.3 ± 15.4 和 70.7 ± 11.7%。在 0 dB SNR 时的平均 CUNY 分数在 12 个月后分别为 14.6 ± 17.2、47.1 ± 22.1 和 72.2 ± 21.5。
本次临床试验获得的数据与之前的报告相符。在很大一部分受试者中,听力保护似乎是成功的,并且 EAS 联合使用在安静和噪声环境下都能提供出色的言语感知能力。
4 级。