Wide-bandwidth open canal hearing aid for better multitalker speech understanding

描述（由申请人提供）：我们的目标是设计和建造一种新的助听器系统，以减轻助听器用户最常见的抱怨。最常见的抱怨包括在多人交谈的情况下难以理解语言，声音质量差，不喜欢他们放大的声音，以及由声音反馈引起的不想要的口哨声。目前的努力，与有限的成功，使用信号处理方法，而不是恢复更接近正常的听觉功能。与传统助听器相比，这款助听器需要具备三个关键特征。第一种是用直接驱动鼓膜的非声学机械输出换能器取代现有的声学换能器。这种传感器被称为EarLens，它漂浮在鼓膜上的方式类似于收缩晶体漂浮在眼睛上的方式。二是增加助听器的输出带宽。第三种方法是在耳道中放置一个宽带麦克风，以类似于正常耳朵功能的方式捕捉耳廓衍射信号。我们的中心假设是一种助听器，它可以提供放大的宽带声音和方向依赖的耳廓线索，在一个开放的管道配置中，将比传统的助听器表现更好，特别是在有竞争的说话者存在的情况下。在第二阶段的SBIR应用中，提出了四个具体目标。所有的助听器都需要“频率增益”处方。然而，目前的处方方法仅限于低于6khz的频率，并且拟合标准仅限于提供可听性和舒适性，而没有考虑保留声音定位线索。为了解决这些问题，将利用响度模型开发一种新的高频拟合处方，并对听障受试者进行测试。在具体目标# 2中，初始EarLens系统原型将适合听力受损的受试者。建议的测量包括：(1)听力学频率在0.125至10 kHz之间的功能增益；(2)“从掩蔽的空间释放”，或者在对称分离的多说话者掩蔽器存在的情况下识别目标语音的能力；(3)“更好的耳朵优势”，其中目标和掩蔽物不对称地排列，使得目标比另一个更靠近一只耳朵。后两个实验是用EarLens进行的，EarLens只放大特定带宽的声音，范围从4到10千赫。对于Specific Aim # 3，我们寻求建立一个适合外部临床试验的耳后（BTE）原型-“alpha原型”。提出了包括工业设计、机械设计、用户界面和电缆设计在内的许多设计变更。在具体目标#4中，EarLens听力系统的临床试验将在全国四个临床地点进行。临床试验的目的是获得足够的数据，以便在完成本申请中提出的工作后向FDA提交510(k)申请。美国600万助听器用户中的大多数都报告了各种放大问题。我们的目标是设计一种与正常听觉功能更密切相关的高保真度开放通道助听器，从而为大脑提供关键线索，使其能够区分来自不同方向的声音，从而使听者能够有选择性地听到，并能够从干扰语音中理解所需的语音。作为这种方法的结果，预计将有更大的满意度使用拟议的助听器比目前市场上的。

DESCRIPTION (provided by applicant): Our goal is to design and build a new hearing aid system, which mitigates the most common complaints that hearing aid users have. The most frequently cited complaints include difficulty understanding speech in multi-talker situations, poor sound quality, dislike of the sound of their amplified voice, and unwanted whistling sounds caused by acoustic feedback. Current efforts, with limited success, use signal processing methods rather than restoring more closely the normal auditory function. There are three key features needed to make this hearing aid a reality that differentiate it from conventional hearing aids. The first is to replace the current acoustic transducer with a non-acoustic mechanical output transducer that directly actuates the tympanic membrane. This transducer, called the EarLens, floats on the tympanic membrane in a manner similar to the way a contract lens floats on the eye. The second is to increase the output bandwidth of the hearing aid. The third is to place a wide-bandwidth microphone in the ear canal to capture the pinna diffraction cues, in a similar manner to the functioning of a normal ear. Our central hypothesis is that a hearing aid that delivers amplified wide-bandwidth sound and directionally dependent pinna cues with a microphone in an open canal configuration will perform better than conventional hearing aids, especially with the presence of competing talkers. In this phase II SBIR application four specific aims are proposed. All hearing aids require a "frequency-gain" prescription. However, current prescription methods are limited to frequencies below 6 kHz and the criteria for fitting have been limited to providing audibility and comfort with no considerations being made to preserve sound localization cues. To address these issues, a new high- frequency fitting prescription will be developed using a loudness model and tested on hearing-impaired subjects. In Specific Aim # 2, an initial EarLens system prototype will be bilaterally fit on hearing-impaired subjects. Proposed measurements include: (1) functional gain at audiometric frequencies between 0.125 to 10 kHz; (2) "spatial release from masking" or the ability to discern a target speech in the presence of symmetrically separated multi-talker maskers; (3) the "better ear advantage" in which the target and masker are arranged asymmetrically such that the target lies closer to one ear than the other. The latter two experiments are conducted with EarLens configured to only amplify sounds over specific bandwidths, which will range from 4 to 10 kHz. For Specific Aim # 3, we seek to build a behind-the-ear (BTE) prototype suitable for an external clinical trial - the "alpha prototype". A number of design changes including industrial design, mechanical design, user interface, and cable design are proposed. And in Specific Aim #4, a clinical trial of the EarLens hearing system will be conducted at four clinical sites located around the country. The objective of the clinical trial is to obtain sufficient data for a 510(k) submission to the FDA upon completion of the work proposed in this application. Most of the six million hearing aid owners in the US report various amplification problems. Our goal is to design a high fidelity open canal hearing aid that more closely relates to normal auditory function thereby providing the brain with critical cues so that it is able to segregate sounds originating from different directions and thus allow the listener to hear selectively and be able to understand desired speech from interfering speech. As an outcome of this approach, it is expected that there will be greater satisfaction with usage of the proposed hearing aid than those currently on the market.