The Wide-bandwidth EarLens Photonic Hearing System

描述(申请人提供)：助听器使用者经常抱怨在嘈杂的情况下音质差，难以理解语音。目前的护理标准，声学助听器，不能恢复整个听力频谱的可听性，因为技术限制严重限制了4-5 kHz以上的声学放大。为了让受试者听到从125赫兹到10千赫的放大声音，设计和制造了一个耳透镜光子听力系统(PHS)的原型。该系统由两个组件组成：一个是光动力接触式传感器(PKCT)，它在通过无线光接收能量和信号时直接振动鼓膜；另一个是耳后声音处理器(BTE)，它处理传入的声音并传输光。FDA批准的一项IDE研究已经证明了用户受益于扩展带宽小灵通的安全性、性能和可行性。拟议的多地点最终临床研究将提供美国监管部门批准所需的安全性和性能数据。这项研究将对80名轻度至中度听力障碍的受试者进行。四家外部诊所将各招收20名受试者。研究方案包括以下步骤：(1)筛选、登记和独立测听和操作测试；(2)小灵通配对；(3)小灵通测听和操作测试；(4)小灵通移除；以及(5)退出研究。将就以下方面进行结果衡量：(A)安全性；(B)空气传导听力阈值；(C)在安静条件下以及在有噪音和言语掩蔽物的情况下的言语理解阈值；(D)评估问卷，以检查自我感知的益处和生活质量的改善。小灵通辅助测量将在初始试穿后和四个月的研究期结束时进行。还将使用受试者自己的声学助听器(如适用)进行B-D测量，以确定小灵通相对于当前护理标准的好处。在美国市场上拥有扩展带宽辅助听力设备的意义在于，这样的系统将首次允许轻度到中度听力障碍的个人受益于声音质量和言语辨别能力的改善，当高频声音提示被清楚地感知时，这是可能的。听力技术的这种进步可能会导致听力设备的采用率增加，这将有助于缓解沟通困难，并改善受听力损失影响的人的整体生活质量。

DESCRIPTION (provided by applicant): Hearing-aid users often complain of poor sound quality and difficulty understanding speech in noisy situations. The current standard of care, acoustic hearing aids, cannot restore audibility across the whole frequency spectrum of hearing because technical constraints severely limit acoustic amplification above 4-5 kHz. A prototype EarLens Photonic Hearing System (PHS) was designed and built to allow subjects to hear amplified sounds from 125 Hz up through 10 kHz. The system is comprised of two components: a PhotoKinetic Contact Transducer (PKCT) that directly vibrates the eardrum upon receiving power and signal through a wireless light and a Behind-The-Ear sound processor (BTE) that processes incoming sound and transmits the light. An FDA-approved IDE study has demonstrated the safety, performance, and feasibility of users to benefit from the extended-bandwidth PHS. The proposed multi-site definitive clinical study will provide the safety and performance data required for regulatory approval in the US. The study will be conducted on a total of 80 subjects with mild-to-moderate hearing impairment. 20 subjects will be enrolled at each of four external clinics. The study protocol involves the following steps: (1) Screening, Enrollment, and Unaided Audiometric and Performance Testing; (2) PHS fitting; (3) PHS Audiometric and Performance Testing; (4) PHS Removal; and (5) Study Exit. Outcome measurements will be made with regard to: (A) safety; (B) air-conduction audiometric thresholds; (C) speech-understanding thresholds under quiet conditions and in the presence of noise and speech maskers; and (D) assessment questionnaires to examine self-perceived benefit and quality-of-life improvements. PHS aided measurements will be performed after initial fitting and at the end of the four-month study period. Measurements B-D will also be made using the subjects' own acoustic hearing aids, as applicable, to determine benefit of the PHS over the current standard of care. The significance of having an extended-bandwidth assistive hearing device on the market in the US is that such a system will, for the first time, allow individuals wih mild to moderately severe hearing impairment to benefit from the improvements in sound quality and speech-discrimination ability that become possible when high-frequency acoustic cues are clearly perceived. Such advancement in hearing technology may lead to increased adoption rates for hearing devices, which would help to relieve communication difficulties and improve the overall quality of life for those affected by hearing loss.