Evaluation of micro-epidermal actuators on flexible substrate for noninvasive, pediatric-friendly conductive hearing aid

用于无创、儿科友好型传导助听器的柔性基底上的微表皮执行器的评估

• 批准号: 10204326
• 负责人: Mohammad Moghimi
• 金额: $ 14.06万
• 依托单位: NORTHERN ILLINOIS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10204326
• 关键词: 5 year old; Academic achievement; Acoustics; Address; Adhesions; Adhesives; Adult; Affect; Allergic; Anatomy; Auditory; Back; Bypass; Caliber; Charge; Child; Childhood; Cochlea; Communication; Conductive hearing loss; Coupling; Devices; Ear; Electronics; Epidermis; Evaluation; Excision; Face; Film; Forehead; Frequencies; Friction; Goals; Guidelines; Hearing Aids; Implant; Infant; Labyrinth; Language Delays; Language Development; Life; Mechanics; Meningeal; Minor Surgical Procedures; Modulus; Motion; Movement; Newborn Infant; Noise; Obstruction; Operative Surgical Procedures; Otitis Media; Outcome; Pathway interactions; Performance; Pharmaceutical Preparations; Procedures; Quality of life; Reaction; Research; Risk; Route; Schools; Skin; Social Functioning; Speech Development; Stenosis; Surface; Surgeon; Thick; Thinness; Tissues; Transducers; Tympanic Membrane Perforation; Wireless Technology; auditory pathway; biomaterial compatibility; bone; childhood hearing loss; cranium; design; early childhood; efficacy evaluation; elastomeric; electric impedance; flexibility; flexible electronics; hearing impairment; improved; infancy; innovation; light weight; malformation; middle ear; milligram; osseointegrated implant; parylene C; pediatric patients; physical property; polydimethylsiloxane; preservation; prevent; reconstruction; sensor; skills; socioeconomics; sound; success; vibration

SUMMARY Hearing loss during infancy and early childhood has detrimental effects on language and speech development. Hearing loss must be identified and corrected as early as possible to avoid life-long consequences. One major type of pediatric hearing impairment is conductive, in which the auditory pathway in the ear is obstructed or damaged, preventing sounds from properly conducting to the inner ear. Temporary conductive hearing loss (CHL), including otitis media and tympanic membrane perforation, is addressed by medication or a minor surgery. Anatomical conditions such as aural atresia, canal stenosis and ossicular malformation result in permanent CHL and are more difficult to address. Prevalent practice calls for surgical procedures to correct the damage in the pathway or implant hearing aids into the skull to bypass the obstruction in the ear. However, these procedures are invasive and present challenges for newborns and infants. Because of the risks, FDA guidelines prevent children younger than 5 from receiving bone-anchored hearing aids that are standard devices for adults. The long-term goal of this research is to find new strategies to non-invasively transfer sounds into the inner ear and address CHL in pediatric patients. The central hypothesis is that the sounds can be transferred into the inner ear via the skin-bone route with soft hearing aids. The innovation in this project is to integrate chip-scale, ultrathin, micromechanical transducers on flexible substrates to achieve micro-epidermal actuators (MEAs), generating sounds in direct contact with the skin to vibrate the bone and bypass the CHL in a truly non-invasive manner. Our proposed aid will generate 120 dB SPL with ultrathin, low mass, flexible electronics, which have showed promise by robustly sticking to infants' skin. This will eliminate the need for invasive procedures required for corrective surgeries and auditory osseointegrated implants (AOI) as well as the risks and discomfort associated with mechanical actuators and rigid components in the existing aids. The objective of this application is to evaluate the efficacy of the flexible substrate on acoustic coupling, adhesion strength and motion-related noises in soft hearing aids. To that end, we defined three major aims for this project. In aim 1 the acoustic coupling between the epidermis and MEAs will be evaluated and characterized. The hypothesis is that the flexible substrate will reduce the acoustic mismatch with the skin and improve the acoustic coupling into the ear. The noises associated with facial and body motion as well as rubbing noises are characterized in aim 2. The hypothesis is that the soft, conformal, lightweight MEAs will move with facial and body motion, reducing overall noises. The adhesive strength between the skin and MEAs will be evaluated in aim 3. Because of the small size (1.5 cm × 2.5 cm × 300 µm), low mass (120 milligram), and low elastic modulus, the substrates gently bond to the epidermis with adhesion strength 1-2 kPa. The successful implementation of these aims will identify the important features tied to pediatric-friendly conductive hearing aids.

概括 婴儿期和幼儿期间的听力损失对语言和语言有害 发展。必须尽早确定和纠正听力损失，以避免终身后果。 小儿听力障碍的一种主要类型是导电性的，在该听力障碍中，耳朵中的听觉途径为 阻塞或损坏，防止声音正确地进行内耳。临时导电 听力损失（CHL），包括中耳炎和鼓膜膜穿孔，用药物或A来解决 小手术。解剖状况，例如听觉闭锁，运河狭窄和骨畸形导致 永久性CHL，更难解决。普遍的练习需要手术程序来纠正 路径上的损坏或植入助听器辅助颅骨，以绕过耳朵中的异议。但是，这些 程序是侵入性的，对新生儿和婴儿面临挑战。由于有风险，FDA指南 防止5岁以下的儿童接受骨锚助听器，这是成年人的标准设备。 这项研究的长期目标是找到新的策略，以非侵入性地将声音转移到内部 小儿患者的耳朵和CHL。中心假设是声音可以传递到 内耳通过皮肤骨头路线，具有软助听器。该项目的创新是整合芯片尺度， 超薄的柔性底物上的微型机械换能器，以实现微皮肤致动剂（MEAS）， 产生与皮肤直接接触的声音，以振动骨头并绕过CHL，以真正的无创 方式。我们提出的援助将产生120 dB的SPL，具有超薄，低质量，柔性电子设备，它们具有 通过坚固地坚持婴儿的皮肤表现出希望。这将消除对侵入性程序的需求 用于纠正手术和听觉骨整合的instrans（AOI）以及风险和不适 与现有艾滋病中的机械执行器和刚性组件相关。 该应用的目的是评估柔性底物对声耦合的效率， 软助听器中的粘附强度和与运动有关的噪音。为此，我们定义了三个主要目标 这个项目。在AIM 1中，将评估和表征表皮和MES之间的声学​​耦合。 假设是柔性底物将减少与皮肤的声学不匹配并改善 声学耦合到耳朵。与面部和身体运动以及摩擦噪声相关的噪音是 在AIM 2中的特征。假设是，软，保形，轻质的尺寸将以面部和面部移动 身体运动，减少整体噪音。皮肤和测量之间的粘合强度将在 目标3。由于尺寸很小（1.5 cm x 2.5 cm x 300 µm），低质量（120毫克）和低弹性模量， 底物用1-2 kPa轻轻键入表皮。成功实施 这些目标将确定与儿科友好的导电助听器有关的重要特征。