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标是识别患有内耳病变（IEP）的婴儿，但大多数筛查失败的新生儿患有传导障碍（CD）而不是IEP，导致高假阳性率和昂贵的后续诊断评估。罗得岛研究（1993年）表明，传导性疾病（CD）的患病率高于内耳病变（IEP），分别为17/1000和3- 6/1000。而在N1 CU中，CD的患病率超过IEP上升到每1000人36对23。IEP和CD的后果是不同的，因此在新生儿听力筛查时准确分类损失至关重要。本提案的主要目的是构建一种听力筛查设备，该设备将宽带反射测量与DPOAE测量结合到一个系统中，其中前者提供CD的诊断评估，后者提供IEP的诊断评估。因此，在一个测试中，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，因此使用组合筛查设备进行听力筛查所需的额外时间将不超过几分钟。预期结果的益处是降低假阳性率，降低后续诊断成本，并减少假阳性情况下的父母担忧。 通过反射率测量获得的探头阻抗的重要辅助益处是允许直接估计耳道中的信号强度水平，以便减轻听力测量中的驻波问题。结合DPOAE测量，WR-DP筛选器将提供更准确的测量超过3 kHz的驻波问题发生。 第二阶段的具体目标是：（1）完成宽带反射-畸变产物耳声发射（WR-DP）筛查设备的开发，以提高其效率、可靠性和易用性;（2）进行临床研究，获得WR-DP筛查仪的基线数据;（3）证明WR-DP筛查仪的诊断能力和成本效益。

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.