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的空气和骨导测试的新型测试程序，以便更好地并一致地检测轻度听力损失（< 35 dB nHL）。申报器械将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组件，从而满足当前对更灵敏听力筛查工具的需求。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I阶段，该技术得到扩展，并与使用各种方法的同时空气和骨传导测试相结合，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证明了所提出的技术的可行性，使用10名成年受试者正常和模拟传导性听力损失。此外，还对10名NICU新生儿进行了测试，以证明所提出的技术可应用于目标人群。 在第二阶段，将继续进一步开发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名），实际传导性听力损失（20名）和感觉神经性听力损失（20名）。婴儿将包括来自NICU的100名新生儿，其中婴儿未能通过常规听力筛查，以及与通过新生儿筛查的婴儿相比，勉强通过筛查的婴儿。将从实验方案获得的结果与包括频率特异性AEP测试的综合诊断听觉电池进行比较。 还将开发更适合于测试新生儿的新一代高保真骨传导立体声刺激器。 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，并实施更有效的重新筛查政策。

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.