Post-market Study to Capture Information Regarding Performance of Extended Wear Hearing Aid Lyric2 Compared to Lyric
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 177
- 试验地点
- 2
- 主要终点
- Immediate Refit Upon Device Removal
研究概览
简要总结
Randomized post market study comparing Lyric to Lyric2 capturing information regarding comparative performance and safety.
详细描述
Randomized post market study comparing extended wear hearing aids Lyric to Lyric2 capturing information regarding comparative performance and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-90 years at the time of enrollment in the study
- •Mild to moderately-severe hearing loss bilaterally, or unilaterally if normal hearing in other ear
- •Fluent in English
- •Willingness to comply with all study requirements
排除标准
- •Scuba dives or sky dives
- •Underwater swimming or dives into the water
- •Handicaps that would restrict participation in all the evaluations
- •Hearing loss of neural or central origin
- •Unrealistic expectations regarding benefits and limitations inherent in the devices
- •Chemotherapy within the last six months
- •Compromised immune system
- •Radiation to head or neck
- •Perforated tympanic membrane
- •History of cholesteatoma
- •Active outer or middle ear pathology
- •High levels of anticoagulant therapy
- •Insulin-dependent and/or uncontrolled diabetes
- •Contact dermatitis
- •Bleeding disorder
- •Unwillingness or inability to comply with all study requirements
结局指标
主要结局
Immediate Refit Upon Device Removal
时间窗: Following device removal at the same appointment (Up to 24 hours after removal)
Upon device removal, a qualified audiologist examined subjects' ears to evaluate their availability to be immediately refit with another hearing aid device. It is not uncommon for patients being fitted with these types of devices to experience slight irritation on an initial experience with the device. In particular, those being fit with the Lyric or Lyric2.0 for the first time first undergo the device sizing process, which slightly increases stress on the ear.
次要结局
- Device Comfort(During useful lifespan of device)
- Gain, Speech Understanding and Sound Quality(During useful lifespan of device)