Bone Conduction Testing for Newborn Hearing Screening

描述（由申请人提供）：本研究旨在开发一种改进的新生儿听力筛查设备，该设备将结合同时进行空气和骨传导测试的新测试程序，以便更好和一致地检测轻度听力损失（< 35 dB nHL）。提出的设备将解决当前对更敏感的听力筛查工具的需求，通过使用刺激强度斜坡技术在较低水平进行刺激，并提供骨传导刺激，以区分感音神经和传导成分。智能听力系统先前开发了刺激强度斜坡技术，用于快速确定频率特定的AEP听力阈值。在第一阶段，该技术扩展并结合了同时进行的空气和骨传导测试，使用了各种方法，包括：A)双速率空气-骨刺激和B)重叠空气-骨强度-斜坡刺激和C)交织空气-骨刺激。在第一阶段进行的实验中，10名正常和模拟传导性听力损失的成年受试者证明了所提出技术的可行性。此外，还对10名新生儿进行了测试，以证明所提出的技术可以应用于目标人群。在第二阶段，工作将继续进一步发展第一阶段实施的技术，并将对60名成年人进行更全面的临床研究，其中包括正常和模拟传导性听力损失（20），实际传导性听力损失（20）和感音神经性听力损失（20）。婴儿将包括来自NICU的100名新生儿，其中包括未通过常规听力筛查的婴儿和勉强通过筛查的婴儿，并将结果与通过新生儿筛查的婴儿进行比较。从实验方案中获得的结果将与包括特定频率AEP测试在内的综合诊断听觉电池进行比较。更适合测试新生儿的新一代高保真骨传导立体刺激器的开发也将进行。新开发的同时基于空气和骨传导的听力筛查技术将允许更好地识别和管理听力损失病例，并实施更有效的再筛查政策。

DESCRIPTION (provided by applicant): This study aims to develop an improved neonatal hearing screening device that will incorporate novel testing procedures combining simultaneous air and bone conduction testing so that mild hearing losses (< 35 dB nHL) are better and consistently detected. The proposed device will address the current need for a more sensitive hearing screening tool by stimulating at lower levels using a Stimulus Intensity-Ramping technique and providing bone conduction stimulation in order to differentiate between sensorineural and conductive components. Intelligent Hearing Systems previously developed the Stimulus Intensity-Ramping technique for quickly determining frequency specific AEP hearing thresholds. During Phase I, this technique was expanded and combined with simultaneous air and bone conduction testing using various approaches, including: A) Dual-Rate Air-Bone stimulation and B) Overlapping Air-Bone Intensity- Ramping Stimulation and C) Interweaving Air-Bone stimulation. Experiments conducted during Phase I demonstrated the feasibility of the proposed techniques using 10 adult subjects with normal and simulated conductive hearing losses. In addition, testing was also conducted on 10 NICU newborns in order to demonstrate that the proposed technique could be applied to the target population. During Phase II, work will continue to further develop the techniques implemented during Phase I and a more comprehensive clinical study will be conducted using 60 adults, with normal and simulated conductive hearing loss (20), actual conductive hearing loss (20) and sensorineural hearing loss (20). Infants will include 100 newborns from the NICU with infants failing routine hearing screening and those marginally passing screening recruited with results compared to infants who pass newborn screening. The results obtained from the experimental protocol will be compared to a comprehensive diagnostic auditory battery including frequency specific AEP testing. Development of a new generation of a high fidelity bone-conduction stereo stimulator more suitable for testing newborns will also be conducted. The newly developed simultaneous air and bone conduction based hearing screening techniques will allow for better identification and management of hearing loss cases and implementation of more efficient rescreening policies.