Audiological Benefit With Non-implantable Bone Conduction Hearing Systems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Speech reception threshold in noise (S0NDIFF)
研究概览
简要总结
Recently, a new non-invasive bone conduction hearing aid was introduced. The system is connected directly to the skin with an adhesive adapter to transmit the sound to the inner ear through bone vibrations. The objective of this study is to evaluate and compare the audiological benefit of the new bone conduction hearing aid and compare it to an existing bone conduction hearing aid in normal hearing adults with bilateral simulated conductive hearing loss.
An evaluation of the improvement on speech understanding in noise and sound localization allows to estimate the system performance and enables to derive recommendations for clinical usage of the novel hearing system. It is hypothesized that in the bilateral condition similar speech understanding in noise and sound localization performance can be achieved with the new system compared to existing bone conduction hearing aids that are pressed against the skull using a soft band.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Adults (age ≥ 18 years on the test date)
- •Normal hearing thresholds (AC/BC-thresholds ≤ 20 dB HL, 0.25 to 8 kHz)
- •German native speakers
- •Willingness and ability to perform all tests required for the study
排除标准
- •Lack of compliance with any inclusion criteria
- •Allergy against silicon (ear mold casting mass)
研究组 & 干预措施
AB arm
Sequence:
- Aided with non-invasive bone conduction hearing aid A
- Aided with non-invasive bone conduction hearing aid B
干预措施: Non-invasive bone conduction hearing aid A (Device)
AB arm
Sequence:
- Aided with non-invasive bone conduction hearing aid A
- Aided with non-invasive bone conduction hearing aid B
干预措施: Non-invasive bone conduction hearing aid B (Device)
BA arm
Sequence:
- Aided with non-invasive bone conduction hearing aid B
- Aided with non-invasive bone conduction hearing aid A
干预措施: Non-invasive bone conduction hearing aid A (Device)
BA arm
Sequence:
- Aided with non-invasive bone conduction hearing aid B
- Aided with non-invasive bone conduction hearing aid A
干预措施: Non-invasive bone conduction hearing aid B (Device)
结局指标
主要结局
Speech reception threshold in noise (S0NDIFF)
时间窗: Day 1
Speech reception threshold in noise (in dB SNR) measured with speech presented from the front (0° azimuth) and approximated diffuse noise presented from 4 speakers.
次要结局
- Speech reception threshold in noise (S90NDIFF)(Day 1)
- Subjective evaluation of the sound quality(Day 1)
- Speech reception threshold in noise (S270NDIFF)(Day 1)
- Sound localization(Day 1)