A Noninvasive, Flexible Conductive Hearing Aid With Micro-epidermal Actuators on Pediatric and Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Does the subject indicate hearing or states they can hear sound
研究概览
简要总结
Conductive hearing loss (CHL) is the most common type of hearing loss among the pediatric population. CHL occurs when sound is not properly transmitted from the external ear to the cochlea, and congenital pathologies like microtia/anotia, atresia, and absent or malformed ossicles make hearing loss permanent.
详细描述
Standard treatment for permanent conductive hearing loss includes osseointegrated implants, which require surgery and are invasive for pediatric patients. Conductive hearing loss can also be treated by non-surgical solutions such as wearable and behind-the-ear aids; however, they present challenges such as instability, stigmatization, and discomfort because of the device's design. Therefore, patients (ages 6 months to 80 years) with permanent (CHL) can benefit from a flexible, Band-Aid like hearing aid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female infants, children, adolescents, and adult patients who are diagnosed with unilateral or bilateral mixed or conductive hearing loss
- •Male and female patients seen at Atrium Health-Audiology for a clinical, standard of care office visit who have a diagnosis of conductive or mixed hearing loss and may currently wear hearing aids
- •Male and female infants, children, adolescents, and adults who are candidates for conductive hearing aids (Osseo-integrated or wearable aids) or for canalplasty or ossicular chain reconstruction surgery
- •Healthy subjects will include male and female infants, children, adolescents, and adults who do not have conductive or mixed hearing loss
- •Pregnant women -are eligible for this study. Standard of Care allows pregnant patients to be fit for hearing aids without risk.
排除标准
- •Adult patients unable to independently understand the purpose of the study and the procedures and/or who are not willing to participate
研究组 & 干预措施
flexible Band-Aid style hearing device
Patients with conductive/mixed hearing loss will be assessed to observe their hearing threshold before using the hearing aid and reassessed with our hearing aid attached. Healthy subjects will wear noise-cancelling headphones and ear plugs to simulate conductive hearing loss, and their hearing threshold will be assessed before and during the flexible hearing aid attachment.
干预措施: flexible conductive hearing aid (Device)
结局指标
主要结局
Does the subject indicate hearing or states they can hear sound
时间窗: Hour 1
Voltage (with a maximum of 20 V, frequency range: 20 Hz to 20 kHz) will be applied to Micro epidermal actuator (MEA) through external power supply/function generator, or through amplifier in the hearing aid circuit. While wearing the device, they are asked to respond or repeat when they hear sound either delivered through the device or through the speaker on the wall in front of them. All sounds are presented at a comfortable level.
次要结局
未报告次要终点