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

描述(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，但大多数未通过筛查的新生儿患有传导性障碍(CD)而不是IEP，导致高假阳性率和昂贵的后续诊断评估。罗德岛的研究(1993)表明，传导性疾病(CD)的患病率比内耳病变(IEP)高17比3-6/1000。而在N1CU，CD的患病率比IEP上升到36/1000，而不是23/1000。IEP和CD的后果是不同的，因此在新生儿听力筛查时对损失进行准确的分类是至关重要的。该方案的主要目标是建立一种将宽带反射测量和DPOAE测量结合在一起的听力筛查设备，其中前者提供CD的诊断评估，后者提供IEP的诊断评估，从而在一次测试中同时评估传导路径和耳蜗声发射状态。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不会超过几分钟。预期结果的好处是降低了假阳性率，降低了后续诊断成本，并在假阳性的情况下减少了父母的担忧。 通过反射率测量获得的探头阻抗的一个重要辅助好处是允许直接估计耳道中的信号强度水平，从而减轻听力测量中的驻波问题。与DPOAE测量相结合，WR-DP筛网将在3 kHz以上发生驻波问题时提供更准确的测量。 第二阶段的具体目标是(1)完成宽带反射失真产物耳声发射(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筛查设备的基线数据；以及(3)展示WR-DP筛查设备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.