Hearing Outcomes Using Super-power Processors in Bone Anchored Implant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Speech perception in quiet
研究概览
简要总结
The purpose of this study is to assess the benefit of new super-power bone-anchored hearing aid (BAHA) processors in BAHA users. BAHAs are able to help people with mixed/conductive and single-sided hearing loss when they are unable to use or receive limited benefit from traditional hearing. Until recently, BAHAs were only recommended to people with up to a moderate hearing loss. New super-power BAHA processors may be able to help people who previously were not candidates for BAHAs or received limited benefit from them. The information collected in this study may lead to improved evaluation of and expanded treatment options for people considering BAHA. Different types of hearing tests will be used to compare the devices.
详细描述
The objective of this study is to assess the benefit of new super-power bone-anchored hearing aid (BAHA) processors in BAHA users. BAHAs are able to help people with mixed/conductive and single-sided hearing loss when they were not receiving benefit from traditional hearing aids or could not use them due to differences in their ears related to surgery or congenital anomalies. Stronger super-power processors may be able to help individuals who previously did not meet candidacy for BAHA. This study will evaluate how much benefit they are getting from their current devices compared to new super-power devices.
The information collected in this study may lead to improved evaluation of patients considering BAHA implantation and expanded treatment options for new and existing BAHA users. Primary outcome measures will include hearing threshold and speech perception measures. All devices are commercially available and FDA approved.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •meet candidacy criteria for a high gain super-power processor with a fitting range up to 65 dB
- •native English speaker
排除标准
- •do not meet inclusion criteria
结局指标
主要结局
Speech perception in quiet
时间窗: 1 hour
Word understanding will be evaluated without hearing devices and then using the individual's current BAHA processor and super power BAHA processor
Speech perception in noise
时间窗: 1 hour
Speech perception in noise will be evaluated without hearing devices and then using the individual's current BAHA processor and super power BAHA processor
Threshold testing
时间窗: 1 hour
Conventional hearing test will be performed. Sound field testing will be performed to establish aided thresholds using the individual's current BAHA processor and super power BAHA processor
次要结局
未报告次要终点
研究者
Hillary A Snapp
Assistant Professor
University of Miami