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，满足当前对更灵敏听力筛查工具的需求。智能听力系统先前已经开发了一种刺激强度斜坡技术，用于快速确定频率特定的AEP听力阈值。该技术将被扩展并与使用各种方法的骨传导测试相结合，包括：A）交织空气-骨刺激，B）双速率空气-骨刺激和C）重叠空气-骨强度-斜坡刺激。新一代高保真骨传导立体声耳机将用于提供刺激。 在第一阶段，IHS听力筛查设备的当前软件和硬件将进行修改，以适应拟议的双耳同时空气和骨传导测试范例。将进行实验，以确定结合这些测试范例的可行性，并确定其有效性和效率。将从10名听力正常的年轻人和15名新生儿中收集数据。将对新的生物技术进行测试，以确定拟议技术在目标人群中的可行性。在第二阶段，将对新生儿进行全面的临床研究。这种新方法将有助于更好地管理听力损失病例，并实施更有效的重新筛选政策。 公共卫生相关性：新生儿听力筛查是早期识别婴儿听力损失的重要评估工具。所提出的自动化双空气和骨刺激和分析技术的实施有望大大提高听力筛查的可靠性和有效性。因此，拟议的工作将通过开发更好的新生儿听力筛查系统对公共卫生产生重大影响。

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 and providing bone conduction stimulation in order to differentiate between sensorineural and conductive components. Intelligent Hearing Systems has previously developed a Stimulus Intensity-Ramping Technique for quickly determining frequency specific AEP hearing thresholds. This technique will be expanded and combined with bone conduction testing using various approaches, including: A) Interweaving Air-Bone stimulation, B) Dual-Rate Air-Bone stimulation and C) Overlapping Air-Bone Intensity-Ramping Stimulation. A new generation of high fidelity bone-conduction stereo headphones will be used to deliver stimuli. During Phase I, the current software and hardware of the IHS hearing screening device will be modified to accommodate the proposed dual-ear simultaneous air and bone conduction testing paradigm. Experiments will be conducted to determine the feasibility of combining these testing paradigms and to determine their effectiveness and efficiency. Data will be collected from 10 young adults with normal hearing and 15 newborns. Newborns will be tested in order to determine the feasibility of the proposed technique on the target population. During Phase II, a comprehensive clinical study will be conducted on newborns. This new approach will allow for better management of hearing loss cases and implementation of more efficient rescreening policies. PUBLIC HEALTH RELEVANCE: Newborn hearing screening is an important assessment tool in the early identification of infants hearing loss. The implementation of the proposed automated dual air and bone stimulation and analysis techniques is expected to greatly improve thereliability and validity of hearing screening. As such, the proposed work will greatly impact public health by developing better newborn hearing screening systems.