Subjective Satisfaction and Audiological Benefit With ADHEAR Audio Processor and ADHEAR Adhesive Adapter in Children
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Maximal decibels gain measured by Audiological basic tests
研究概览
简要总结
A hearing loss affects the quality of life and the natural development of children.
The new generation of hearing devices provides a huge number of options to them. These new hearing aids are often aesthetically acceptable, less invasive and user-friendly.
The ADHEAR Non-Implantable Bone Conduction Hearing System is connected directly to the skin with a special adhesive adapter. The device transmits the sound to the mastoid by vibrating on the skull and stimulates the inner ear without any previous surgery.
The objective of this study is to evaluate of the audiological benefit and subjective satisfaction of ADHEAR Audio Processor with Adhesive attachment in a group of children suffering from conductive hearing loss and/or single sided deafness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral and/or bilateral CHL (e. g. BC-thresholds <25dB HL)
- •Ability to perform all tests required for the study
- •Signed, and dated informed consent by parents and children where applicable
排除标准
- •intolerant of the materials
- •patient with a skin or scalp condition that may preclude the attachment of the adhesive plaster
- •fluctuation of hearing loss over a two year period of 15dB in either direction
- •retrocochlear, or central auditory disorders
- •any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures
研究组 & 干预措施
ADHEAR Audio processor
干预措施: ADHEAR Audio Processor (Device)
结局指标
主要结局
Maximal decibels gain measured by Audiological basic tests
时间窗: Week 3
Maximal decibels gain measured by speech reception threshold in quiet
时间窗: Week 3
次要结局
- Change from baseline in Quality of Life measured by the SSQ12 questionnaire(month 12)
- Comparison of maximal decibels gain measured by Audiological basic tests between ADHEAR Audio Processor and Cochlear bone anchored hearing aid.(Day 0)
- Comparison of maximal decibels gain measured by speech reception threshold in quiet between ADHEAR Audio Processor and Cochlear bone anchored hearing aid(Day 0)
- Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire(month 12)
- Incidence of device-emergent adverse event.(Up to 1 year after start of study device utilization)
- Number of subjects who discontinue study device utilization due to any AE or dissatisfaction(Year 1)
- Average time of daily use of ADHEAR System(week 3)