“自由核”北美临床试验。
Nucleus Freedom North American clinical trial.
作者信息
Balkany Thomas, Hodges Annelle, Menapace Christine, Hazard Linda, Driscoll Colin, Gantz Bruce, Kelsall David, Luxford William, McMenomy Sean, Neely J Gail, Peters Brian, Pillsbury Harold, Roberson Joseph, Schramm David, Telian Steven, Waltzman Susan, Westerberg Brian, Payne Stacy
机构信息
University of Miami Ear Institute, Miami, FL 33101, USA.
出版信息
Otolaryngol Head Neck Surg. 2007 May;136(5):757-62. doi: 10.1016/j.otohns.2007.01.006.
OBJECTIVE
To evaluate hearing outcomes and effects of stimulation rate on performance with the Nucleus Freedom cochlear implant (Cochlear Americas, Denver, CO).
STUDY DESIGN AND SETTING
Randomized, controlled, prospective, single-blind clinical study using single-subject repeated measures (A-B-A-B) design at 14 academic centers in the United States and Canada and comparison with outcomes of a prior device by the same manufacturer.
PATIENTS
Seventy-one severely/profoundly hearing impaired adults.
RESULTS
Seventy-one adult recipients were randomly programmed in two different sets of rate: ACE or higher rate ACE RE. Mean scores for Consonant Nucleus Consonant words is 57%, Hearing in Noise Test (HINT) sentences in quiet 78%, and HINT sentences in noise 64%. Sixty-seven percent of subjects preferred slower rates of stimulation, and performance did not improve with higher rates of stimulation using this device.
CONCLUSIONS
Subjects performed well, and there was no advantage to higher stimulation rates with this device.
SIGNIFICANCE
Higher stimulation rates do not necessarily result in improved performance.
目的
评估使用Nucleus Freedom人工耳蜗（美国科利耳公司，科罗拉多州丹佛市）时的听力结果以及刺激速率对其性能的影响。
研究设计与设置
在美国和加拿大的14个学术中心采用单受试者重复测量（A - B - A - B）设计进行随机、对照、前瞻性、单盲临床研究，并与同一制造商先前设备的结果进行比较。
患者
71名重度/极重度听力受损成年人。
结果
71名成年接受者被随机设定为两种不同的刺激速率组：ACE或更高速率的ACE RE。辅音核辅音单词的平均得分是57%，安静环境下噪声中听力测试（HINT）句子的得分是78%，噪声环境下HINT句子的得分是64%。67%的受试者更喜欢较慢的刺激速率，使用该设备时较高的刺激速率并未提高性能。
结论
受试者表现良好，该设备使用较高刺激速率并无优势。
意义
较高的刺激速率不一定会带来性能的提升。
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