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构建一种新的助听器系统，以减轻助听器用户最常见的投诉。最常见的抱怨包括在多人说话的情况下难以理解语音，音质差，不喜欢他们放大的声音，以及由声学反馈引起的不必要的哨声。目前的努力，有限的成功，使用信号处理方法，而不是更密切地恢复正常的听觉功能。有三个关键特征需要使这种助听器成为现实，使其区别于传统助听器。第一种是用直接致动鼓膜的非声学机械输出换能器代替当前的声学换能器。这种传感器称为耳透镜，以类似于隐形透镜浮在眼睛上的方式浮在鼓膜上。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线索。我们的中心假设是，一个助听器，提供放大的宽带宽的声音和方向相关的耳廓线索与麦克风在一个开放的通道配置将比传统的助听器，特别是与竞争的谈话者的存在更好。在第二阶段SBIR应用中，提出了四个具体目标。所有助听器都需要“频率增益”处方。然而，目前的处方方法限于低于6 kHz的频率，并且用于拟合的标准已被限制为提供可听度和舒适度，而没有考虑保留声音定位线索。为了解决这些问题，将使用响度模型开发新的高频拟合处方，并在听力受损受试者中进行测试。在特定目标#2中，最初的EarLens系统原型将在听力受损的受试者身上进行双侧适配。建议的措施包括：（1）在0.125至10 kHz之间的听力测定频率下的功能增益;（2）“掩蔽的空间释放”或在对称分离的多说话者掩蔽者存在下辨别目标语音的能力;（3）“更好的耳朵优势”，其中目标和掩蔽者不对称地布置，使得目标比另一只耳朵更靠近一只耳朵。后两个实验使用EarLens进行，EarLens配置为仅放大特定带宽的声音，范围从4到10 kHz。对于特定目标#3，我们寻求构建适合外部临床试验的耳后（BTE）原型-“alpha原型”。提出了许多设计变更，包括工业设计、机械设计、用户界面和电缆设计。在具体目标#4中，EarLens听力系统的临床试验将在全国各地的四个临床地点进行。本临床试验的目的是在完成本申请中提出的工作后，获得向FDA提交510（k）申请所需的充足数据。在美国，600万助听器拥有者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高保真的开放式耳道助听器，它与正常的听觉功能更密切相关，从而为大脑提供关键线索，使其能够分离来自不同方向的声音，从而使听者能够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，预计所提出的助听器的使用将比目前市场上的助听器更令人满意。

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.