1 Department of Otolaryngology/Head and Neck Surgery, 2331 University of North Carolina School of Medicine , Chapel Hill, NC, USA.
2 Department of Audiology, 2334 UNC Health Care , Chapel Hill, NC, USA.
Trends Hear. 2018 Jan-Dec;22:2331216518771173. doi: 10.1177/2331216518771173.
A FDA clinical trial was carried out to evaluate the potential benefit of cochlear implant (CI) use for adults with unilateral moderate-to-profound sensorineural hearing loss. Subjects were 20 adults with moderate-to-profound unilateral sensorineural hearing loss and normal or near-normal hearing on the other side. A MED-EL standard electrode was implanted in the impaired ear. Outcome measures included: (a) sound localization on the horizontal plane (11 positions, -90° to 90°), (b) word recognition in quiet with the CI alone, and (c) masked sentence recognition with the target at 0° and the masker at -90°, 0°, or 90°. This battery was completed preoperatively and at 1, 3, 6, 9, and 12 months after CI activation. Normative data were also collected for 20 age-matched control subjects with normal or near-normal hearing bilaterally. The CI improved localization accuracy and reduced side bias. Word recognition with the CI alone was similar to performance of traditional CI recipients. The CI improved masked sentence recognition when the masker was presented from the front or from the side of normal or near-normal hearing. The binaural benefits observed with the CI increased between the 1- and 3-month intervals but appeared stable thereafter. In contrast to previous reports on localization and speech perception in patients with unilateral sensorineural hearing loss, CI benefits were consistently observed across individual subjects, and performance was at asymptote by the 3-month test interval. Cochlear implant settings, consistent CI use, and short duration of deafness could play a role in this result.
一项 FDA 临床试验旨在评估 Cochlear 植入物(CI)对单侧中重度感音神经性听力损失成年人的潜在益处。研究对象为 20 名单侧中重度感音神经性听力损失且对侧听力正常或接近正常的成年人。将 MED-EL 标准电极植入受损耳。评估指标包括:(a)水平面上的声音定位(11 个位置,-90°至 90°),(b)CI 单独使用时在安静环境下的单词识别,以及(c)目标在 0°时的掩蔽句子识别和掩蔽器在-90°、0°或 90°。该测试在术前、CI 激活后 1、3、6、9 和 12 个月完成。还收集了 20 名年龄匹配的双侧听力正常或接近正常的对照组的正常数据。CI 提高了定位精度并减少了侧偏。CI 单独使用时的单词识别能力与传统 CI 使用者的表现相似。当掩蔽器来自正常或接近正常听力的正面或侧面时,CI 提高了掩蔽句子的识别能力。CI 在前 3 个月测试间隔内的双耳增益增加,但此后似乎稳定。与单侧感音神经性听力损失患者的定位和言语感知的先前报告相反,CI 的益处一致存在于个体受试者中,并且在 3 个月的测试间隔内达到了渐近线。CI 设置、持续使用 CI 和耳聋持续时间短可能是造成这种结果的原因。