OTOREFLECTANCE ASSESSMENT OF MIDDLE-EAR FUNCTIONING

描述（由申请人提供）：耳反射（OR）是一种新型的听力测试仪器，利用耳道中呈现和记录的声学信号。OR仪器解决了现有仪器在筛查和诊断中耳功能方面的以下局限性：(1)检测中耳炎，(2)预测传导性听力损失，(3)在接受新生儿听力筛查检查或随访听力学评估的婴儿中检测中耳功能障碍，以及(4)一般用于评估语音带宽频率的中耳功能。OR测试提供在宽带范围内（约0.25至8 kHz）测量诸如反射率和导纳等传递函数以及耳道和中耳吸收的功率。能量反射率和吸收功率是对探头在耳道中的位置相对不敏感的OR函数，因此非常适合解释较高频率下的中耳功能。一种OR仪器可以与类似耳声发射探头的探头一起使用，在耳道环境压力下，在几秒钟内筛查中耳功能。该项目的第一阶段确定了在听力正常的成人和儿童以及手术证实中耳积液的儿童中测量此类OR反应的可行性。第一阶段还实施了宽带OR测试来评估中耳肌肉反射的功能，并将婴儿和成人的反射阈值与传统仪器测量的阈值进行了比较。在第二阶段，将实施宽带OR鼓室测量仪，增加一个泵来改变耳道静压，并测量成人的OR鼓室测量标准。在幼儿中，将比较常压或常规226hz鼓室测量法的测试性能，以检测中耳积液并预测传导性听力损失与积液性中耳炎相关。OR鼓室测量法将成为测量中耳肌肉反射阈值的一种新的客观有效的宽带测试的一部分，该测试将与使用传统测试测量的成人和婴儿阈值进行比较。将在接受标准新生儿听力筛查检查的婴儿中比较OR鼓室测量法、大气压OR鼓室测量法和常规1000 hz鼓室测量法检测中耳功能障碍的能力。II期的结果将评估OR是否比传统测试更准确地筛查和诊断中耳功能障碍，这是社会关注的重要临床应用。

DESCRIPTION (provided by applicant): Otoreflectance (OR) is a new class of hearing-test instruments utilizing acoustic signals presented and recorded in the ear canal. OR instruments address the following limitations in existing instruments to screen and diagnose middle-ear function: (1) detection of otitis media, (2) prediction of conductive hearing loss, (3) detection of middle-ear dysfunction in infants receiving a newborn hearing screening exam or follow-up audiologic assessment, and (4) general use to assess middle-ear function at frequencies in the bandwidth of speech. An OR test provides measurements over a wideband range (approximately 0.25 to 8 kHz) of such transfer functions as reflectance and admittance, and power absorbed by the ear canal and middle ear. Energy reflectance and absorbed power are OR functions that are relatively insensitive to probe position in the ear canal, and thus are well suited to interpreting middle-ear function at higher frequencies. One type of OR instrument can be used with probes similar to otoacoustic emission probes to screen middle-ear function in several seconds at ambient ear-canal pressure. Phase I of this project established the feasibility of measuring such OR responses in normal-hearing adults and children, as well as in children with surgically confirmed middle-ear fluid. Phase I also implemented a wideband OR test to assess the function of the middle-ear muscle reflex, and compared reflex thresholds in infants and adults with thresholds measured using conventional instruments. In Phase II, a wideband OR tympanometry instrument will be implemented, adding a pump to vary ear-canal static pressure, and OR tympanometry norms will be measured in adults. The test performance of ambient-pressure OR and conventional 226-Hz tympanometry will be compared in young children to detect middle-ear fluid and to predict a conductive hearing loss associated with otitis media with effusion. OR tympanometry will form part of a new objective and efficient wideband test to measure middle-ear muscle reflex thresholds, which will be compared to thresholds in adults and infants measured using a conventional test. The test performance of the ability of OR tympanometry, ambient-pressure OR, and conventional 1000-Hz tympanometry to detect middle-ear dysfunction will be compared in infants also receiving a standard newborn hearing screening exam. Outcomes from Phase II will evaluate whether OR is more accurate than conventional tests to screen and diagnose middle-ear dysfunction in clinical applications of important societal concern.