The Wide-bandwidth EarLens Photonic Hearing System

描述（由申请人提供）：助听器用户经常抱怨声音质量差，在嘈杂的环境中难以理解语音。目前的护理标准，声学助听器，不能在整个听力频谱上恢复可听度，因为技术限制严重限制了4-5 kHz以上的声学放大。EarLens光子听力系统（PHS）的原型设计和建造，使受试者能够听到从125 Hz到10 kHz的放大声音。该系统由两个组件组成：一个光动力接触式传感器（PKCT），通过无线光接收功率和信号时直接振动鼓膜;一个耳后声音处理器（BTE），处理传入的声音并传输光。FDA批准的IDE研究已证明了用户从扩展带宽PHS中受益的安全性、性能和可行性。拟定的多中心确定性临床研究将提供美国监管批准所需的安全性和性能数据。本研究将在共计80例轻度至中度听力损伤受试者中进行。将在4家外部诊所各入组20例受试者。研究方案包括以下步骤：（1）筛选、入组和无辅助听力测定和性能测试;（2）PHS适配;（3）PHS听力测定和性能测试;（4）PHS移除;和（5）研究退出。将对以下方面进行结局测量：（A）安全性;（B）气导听力阈值;（C）安静条件下以及存在噪声和言语掩蔽物时的言语理解阈值;（D）评估问卷，以检查自我感知的获益和生活质量改善。PHS辅助测量将在初始拟合后和4个月研究期结束时进行。如适用，还将使用受试者自己的声学助听器进行测量B-D，以确定PHS相对于当前标准治疗的受益。在美国市场上拥有扩展带宽辅助听力设备的重要性在于，这种系统将首次允许轻度至中度听力障碍的个人受益于音质和语音识别能力的改善，当高频声学提示被清晰感知时，这种改善成为可能。听力技术的这种进步可能会导致听力设备的采用率增加，这将有助于缓解听力损失患者的沟通困难，并改善他们的整体生活质量。

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.