Norton S J, Gorga M P, Widen J E, Folsom R C, Sininger Y, Cone-Wesson B, Vohr B R, Mascher K, Fletcher K
Multi-Center Consortium on Identification of Neonatal Hearing Impairment, Seattle, Washington, USA.
Ear Hear. 2000 Oct;21(5):508-28. doi: 10.1097/00003446-200010000-00013.
The purpose of this study was to compare the performance of transient evoked otoacoustic emissions (TEOAEs), distortion product otoacoustic emissions (DPOAEs), and auditory brain stem responses (ABRs) as tools for identification of neonatal hearing impairment.
A total of 4911 infants including 4478 graduates of neonatal intensive care units, 353 well babies with one or more risk factors for hearing loss (Joint Committee on Infant Hearing, 1994) and 80 well babies without risk factor who did not pass one or more neonatal test were targeted as the potential subject pool on which test performance would be assessed. During the neonatal period, they were evaluated using TEOAEs in response to an 80 dB pSPL click, DPOAE responses to two stimulus conditions (L1 = L2 = 75 dB SPL and L1 = 65 dB SPL L2 = 50 dB SPL), and ABR elicited by a 30 dB nHL click. In an effort to describe test performance, these "at-risk" infants were asked to return for behavioral audiologic assessments, using visual reinforcement audiometry (VRA) at 8 to 12 mo corrected age, regardless of neonatal test results. Sixty-four percent of these subjects returned and reliable VRA data were obtained on 95.6% of these returnees. This approach is in contrast to previous studies in which, by necessity, efforts were made to follow only those infants who "failed" the neonatal screening tests. The accuracy of the neonatal measures in predicting hearing status at 8 to 12 mo corrected age was determined. Only those infants who provided reliable, monaural VRA test results were included in the analysis. Separate analyses were performed without regard to intercurrent events (i.e., events between the neonatal and VRA tests that could cause their results to disagree), and then after accounting for the possible influence of intercurrent events such as otitis media and late-onset or progressive hearing loss.
Low refer rates were achieved for the stopping criteria used in the present study, especially when a protocol similar to the one recommended in the National Institutes of Health (1993) Consensus Conference Report was followed. These analyses, however, do not completely describe test performance because they did not compare neonatal screening test results with a gold standard test of hearing. Test performance, as measured by the area under a relative operating characteristic curve, were similar for all three neonatal tests when neonatal test results were compared with VRA data obtained at 8 to 12 mo corrected age. However, ABRs were more successful at determining auditory status at 1 kHz, compared with the otoacoustic emission (OAE) tests. Performance was more similar across all three tests when they were used to identify hearing loss at 2 and 4 kHz. No test performed perfectly. Using either the two- or three-frequency pure-tone average (PTA), with a fixed false alarm rate of 20%, hit rates for the neonatal tests, in general, exceeded 80% when hearing impairment was defined as behavioral thresholds > or =30 dB HL. All three tests performed similarly when a two-frequency (2 and 4 kHz) PTA was used as the gold standard; OAE test performance decreased when a three-frequency PTA (adding 1 kHz) was used as the gold standard definition. For both PTA and all three neonatal screening measures, however, hit rate increased as the magnitude of hearing loss increased.
Singly, all three neonatal hearing screening tests resulted in low refer rates, especially if referrals for follow-up were made only for the cases in which stopping criteria were not met in both ears. Following a protocol similar to that recommended in the National Institutes of Health (1993) Consensus Conference report resulted in refer rates that were less than 4%. TEOAEs at 80 dB pSPL, DPOAE at L1 = 65, L2 = 50 dB SPL and ABR at 30 dB nHL measured during the neonatal period, and as implemented in the current study, performed similarly at predicting behavioral hearing status at 8 to 12
本研究旨在比较瞬态诱发耳声发射（TEOAEs）、畸变产物耳声发射（DPOAEs）和听性脑干反应（ABRs）作为识别新生儿听力障碍工具的性能。
共有4911名婴儿被作为潜在研究对象，其中包括4478名新生儿重症监护病房的毕业生、353名有一个或多个听力损失风险因素的健康婴儿（婴儿听力联合委员会，1994年）以及80名无风险因素但一项或多项新生儿测试未通过的健康婴儿，将在这些对象上评估测试性能。在新生儿期，使用对80 dB pSPL短声的TEOAEs、对两种刺激条件（L1 = L2 = 75 dB SPL和L1 = 65 dB SPL L2 = 50 dB SPL）的DPOAE反应以及由30 dB nHL短声诱发的ABR对他们进行评估。为了描述测试性能，要求这些“有风险”的婴儿在矫正年龄8至12个月时返回进行行为听力学评估，使用视觉强化测听法（VRA），无论新生儿测试结果如何。这些受试者中有64%返回，并且在95.6%的返回者中获得了可靠的VRA数据。这种方法与以往的研究不同，以往的研究必然只努力追踪那些新生儿筛查测试“未通过”的婴儿。确定了新生儿测量方法在预测矫正年龄8至12个月时听力状况的准确性。分析中仅纳入那些提供了可靠的单耳VRA测试结果的婴儿。在不考虑并发事件（即新生儿和VRA测试之间可能导致结果不一致的事件）的情况下进行了单独分析，然后在考虑了诸如中耳炎和迟发性或进行性听力损失等并发事件的可能影响之后进行分析。
本研究中使用的停止标准实现了低转诊率，特别是当遵循与美国国立卫生研究院（1993年）共识会议报告中推荐的方案类似的方案时。然而，这些分析并未完全描述测试性能，因为它们没有将新生儿筛查测试结果与听力的金标准测试进行比较。当将新生儿测试结果与矫正年龄8至12个月时获得的VRA数据进行比较时，所有三项新生儿测试以相对操作特征曲线下面积衡量的测试性能相似。然而，与耳声发射（OAE）测试相比，ABR在确定1 kHz时的听觉状态方面更成功。当用于识别2 kHz和4 kHz处的听力损失时，所有三项测试的性能更相似。没有一项测试表现完美。使用两频率或三频率纯音平均（PTA），在假阳性率固定为20%的情况下，当将听力障碍定义为行为阈值>或=30 dB HL时，新生儿测试的命中率总体上超过80%。当使用两频率（2 kHz和4 kHz）PTA作为金标准时，所有三项测试表现相似；当使用三频率PTA（增加1 kHz）作为金标准定义时，OAE测试性能下降。然而，对于PTA和所有三项新生儿筛查措施，命中率随着听力损失程度的增加而增加。
单独来看，所有三项新生儿听力筛查测试都导致了低转诊率，特别是如果仅针对双耳均未达到停止标准的病例进行后续转诊。遵循与美国国立卫生研究院（1993年）共识会议报告中推荐的方案类似的方案导致转诊率低于4%。在新生儿期测量的80 dB pSPL的TEOAEs、L1 = 65、L2 = 50 dB SPL的DPOAE以及30 dB nHL的ABR，如本研究中所实施的，在预测8至12
