A Wide Band Reflectance - DPOAE (WR-DP) Screener

描述（由申请人提供）：新生儿听力筛查的目的是识别患有内耳病理（IEP）的婴儿，但大多数未通过筛查的新生儿患有传导性障碍（CD）而不是IEP，导致假阳性率高，后续诊断评估成本高。罗德岛研究（1993）表明，传导性疾病（CD）的患病率高于内耳疾病（IEP），分别为17 / 1000和3- 6 / 1000。而在N1CU， IEP的CD患病率上升到36比23 / 1000。IEP和CD的后果是不同的，所以在新生儿听力筛查时准确的听力损失类型是至关重要的。本方案的主要目标是构建一种将宽带反射测量与DPOAE测量相结合的听力筛查装置，前者对CD进行诊断评估，后者对IEP进行诊断评估。评估传导路径和耳蜗状态。由于反射率测量和DPOAE测量都需要相同的校准步骤，因此使用组合筛选装置进行听力筛选所需的额外时间将不超过几分钟。预期结果的好处是降低了假阳性率，降低了随访诊断费用，并减少了假阳性情况下父母的担忧。

DESCRIPTION (provided by applicant): The goal of newborn hearing screening is to identity infants with inner ear pathology (IEP), but most neonates who fail screening have conductive disorders (CD) rather than IEP, resulting in high false positive rates and costly follow-up diagnostic evaluation. The Rhode Island study (1993) has shown that the prevalence of conductive disorders (CD) over inner ear pathologies (IEP) to be 17 vs. 3-to-6 per 1000. While in N1CU the prevalence of CD over IEP rises to 36 vs. 23 per 1000. The ramifications of IEP and CD are different, so an accurate typing of the loss at the time of a newborn hearing screening is essential. The main objective of this proposal is to build a hearing-screening device that combines wideband reflectance measurement with DPOAE measurement into one system, where the former provides diagnostic evaluation for CD and the latter provides diagnostic evaluation for the IEP Thus in one test; both the conductive path and cochlear status are evaluated. Since both the reflectance measurement and the DPOAE measurement require an identical calibration step, the extra time needed to perform hearing screening, using the combined screening device, will be no more than few minutes. The benefit of the expected outcome is reduced false-positive rates, reduces follow up diagnostic costs, and reduced parental concern in the case of false positives. An important auxiliary benefit of the probe impedance, obtained by the reflectance measurement, is to allow for a direct estimate of the signal intensity level in the ear canal so as to mitigate the standing wave problem in the audiometric measurement. In conjunction with DPOAE measurement, the WR-DP screener will provide more accurate measurement above 3 kHz where standing wave problem occurs. The specific aims of Phase II are (1) to complete the development of the wideband reflectance-distortion product otoacoustic emission (WR-DP) screening device, toward improving its efficiency, reliability and ease of use; (2) to perform clinical studies, to obtain baseline data for the WR-DP screener, and (3) to demonstrate the diagnostic capabilities and cost effectiveness of the WR-DP screener.