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 婴儿期和幼儿期的听力损失会对语言和言语产生不利影响 发展。必须尽早识别和纠正听力损失，以避免造成终生后果。 儿童听力障碍的一种主要类型是传导性听力障碍，其中耳朵中的听觉通路是 阻塞或损坏，阻止声音正确传导到内耳。暂时导电 听力损失（CHL），包括中耳炎和鼓膜穿孔，可通过药物或 小手术。耳道闭锁、耳道狭窄和听小骨畸形等解剖学状况导致 永久性CHL并且更难以解决。普遍的做法是要求通过外科手术来纠正 通路损坏或将助听器植入颅骨中以绕过耳朵中的阻塞。然而，这些 该手术具有侵入性，给新生儿和婴儿带来挑战。由于存在风险，FDA 指南 防止 5 岁以下儿童接受成人标准设备的骨锚式助听器。 这项研究的长期目标是找到新的策略，以非侵入性方式将声音传输到体内 耳朵并解决儿科患者的 CHL。中心假设是声音可以转移到 借助软助听器通过皮骨途径进入内耳。该项目的创新在于集成芯片级、 柔性基板上的超薄微机械传感器，以实现微表皮致动器（MEA）， 与皮肤直接接触产生声音，以真正的非侵入性方式振动骨骼并绕过 CHL 方式。我们提议的辅助设备将通过超薄、低质量、柔性电子设备产生 120 dB 声压级，这些电子设备具有 通过牢固地粘附在婴儿的皮肤上而显示出希望。这将消除所需的侵入性手术的需要 矫正手术和听觉骨整合植入物 (AOI) 以及风险和不适 与现有辅助设备中的机械执行器和刚性部件相关。 此应用的目的是评估柔性基板对声耦合的功效， 软助听器中的粘附强度和运动相关噪声。为此，我们确定了三个主要目标 这个项目。在目标 1 中，将对表皮和 MEA 之间的声耦合进行评估和表征。 假设柔性基板将减少与皮肤的声学失配并改善 声耦合到耳朵中。与面部和身体运动以及摩擦噪音相关的噪音 目标 2 中的特征。假设柔软、保形、轻质 MEA 将随着面部和面部移动 身体运动，降低整体噪音。皮肤和 MEA 之间的粘合强度将在 目标 3. 由于尺寸小（1.5 cm × 2.5 cm × 300 µm）、质量低（120 毫克）和低弹性模量， 基材与表皮轻轻粘合，粘合强度为1-2 kPa。的成功实施 这些目标将确定与儿科友好型传导助听器相关的重要特征。