Novel Test of Infant Hearing

项目摘要和摘要 出生后头两年的听力损失(HL)会延迟语言发育，做出早期诊断和 在关键的3-18个月期间进行必要的干预。及早识别听力损失具有重大影响 关于保持正常语言发育的，导致了1-3-6指南，该指南建议婴儿 筛查1个月，诊断3个月，干预6个月。然而，早期测试是不切实际的 使用当前的诊断测试。标准的诊断测试，听觉脑干反应(ABR)，需要 婴儿是静止的，将其适用于睡着或服用镇静剂的婴儿：前者往往产生不完整的数据 由于清醒，镇静剂的使用越来越少，因为担心其对发育的影响。此外， 听力的生理测试，如耳声发射和听性脑干反应，只测试部分听觉通路的缺陷，而遗漏 中枢听觉神经系统的缺陷。最后，使用ABR的决策过程是主观的，缺少 诊断HL的统计学基础。一项对美国西部儿科听力专家的调查显示，鉴于 目前测试的局限性，迫切需要一种替代的方法来评估婴儿的听力 简单、快速、无镇静、客观。 Perceptivo提出了一种基于声音诱导的瞳孔扩张反应(PDR)的新听力测试。PDR是 得益于软件和硬件的进步，以及实现高度精确度的方法创新 视频追踪无头婴儿的瞳孔大小。在相关的3-18个月范围内的婴儿表现出强烈的 在语音快速发展的年龄，保持PDR到语调的一致性。婴儿PDR检测将利用 来自41名听力正常的婴儿的初步数据，以及该团队在使用散瞳技术方面的丰富经验 来评估非人类和成年人类的感觉。到目前为止，我们的数据显示，PDR和 使用受试者反馈评估听力的传统方法。临时专利申请保护了PDR 方法，以及组成PDR系统的软件和硬件。 为了确认PDR是一种诊断测试，必须证明它与PdR一样敏感，并检测出相同的缺陷 ABR在临床环境中。因此，软件、硬件和方法将被优化用于临床 布景。将对80名3-18个月的婴儿进行基于PDR的阈值测量并与ABR阈值进行比较。 在新生儿筛查后转诊，或有HL的高危因素。为了确保比较的有效性， ABR和PDR阈值将在同一天、同一婴儿中使用相似的声音和通过 多恩贝赫儿童医院(OHSU)的同一位听力专家。 收集的数据不仅将验证PDR的临床应用，而且将是第一个系统化的 评估患有或不患有HL的婴儿的声音诱发的瞳孔反应。这些数据将使我们能够寻找 进一步资助开发婴儿听力测试的PDR，特别是提供验证 对于第二阶段SBIR应用是必需的。

PROJECT SUMMARY AND ABSTRACT Hearing loss (HL) in the first two years of life can delay language development, making early diagnosis and intervention essential in the critical 3-18 mo period. Early identification of hearing loss has a significant impact on maintaining normal language development, leading to the 1-3-6 guidelines, which recommend that infants be screened by 1 mo, diagnosed by 3 mo, and receive interventions by 6 mo. However early testing is impractical using current diagnostic tests. The standard diagnostic test, the auditory brainstem response (ABR), requires that infants be still, limiting its applicability to asleep or sedated infants: the former often yields incomplete data due to waking, while sedation is used less and less due to concerns about its impact on development. Further, physiologic tests of hearing such as OAE and ABR only test for deficits in part of the auditory pathway, and miss deficits in the central auditory nervous system. Finally, the decision process using ABR is subjective, lacking a statistical basis for diagnosing HL. A survey of pediatric audiologists in Western US revealed that given the limitations of current tests, there is an urgent need for an alternative method of assessing infant hearing that is simple, quick, sedation-less, and objective. Perceptivo proposes a new hearing test based on the sound-elicited pupil dilation response (PDR). PDR is enabled by advances in software and hardware, as well as methodological innovations that enabled highly precise video tracking of pupil size in head-free infants. Infants in the relevant 3-18 mo range exhibit a strong and consistent PDR to tones at an age when speech is rapidly developing. The infant PDR assay will leverage preliminary data from 41 normal hearing infants, and the team’s considerable experience in using pupil dilation to assess sensation in non-humans and adult humans. Our data to date show that the PDR is as sensitive as traditional methods of assessing hearing using subject feedback. A provisional patent filing protects the PDR methods, and the software and hardware that comprise the PDR system. To validate PDR as a diagnostic test, it must be shown to be as sensitive, and detect the same deficits, as the ABR in a clinical setting. Therefore, software, hardware, and methods will be optimized for use at in a clinical setting. PDR-based thresholds will be measured and compared to ABR thresholds in 80 infants, 3 - 18 mo, who were referred after newborn screening, or have at-risk factors for HL. To ensure the validity of the comparison, ABR and PDR thresholds will be measured in the same infant, on the same day, using similar sounds and by the same audiologist at the Doernbecher Children’s Hospital (OHSU). Data gathered will not only validate clinical application of the PDR, but will be the first systematic assessment of sound-elicited pupil responses in infants with or without HL. This data will enable us to seek further funding for development of the PDR as a test for infant hearing, and specifically, provide the validation necessary for a Phase 2 SBIR application.