Effect of Hearing Aid Labeling on Speech Understanding Measures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Quick Speech in Noise Test (QuickSIN)
研究概览
简要总结
New and experienced hearing aid users will be fit with two hearing devices. One will be labeled as an OTC (Over-The-Counter) device, the other will be labeled as a Prescriptive (i.e. professionally fit) device. Both devices will be generically programmed for a mild to moderate hearing loss. An objective speech in noise test will be completed with both devices.
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
- Single (Investigator)
盲法说明
Participants will be told they are wearing either a prescriptive hearing aid or an OTC (Over-The-Counter) hearing device based on the labeling of the hearing aids. Both sets of devices will actually be the same. The investigator that is scoring the objective speech in noise test will not know which device the participant is wearing at the time of the test (i.e., the set that is labeled as prescriptive or the set that is labeled as OTC).
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults age 18 or older with bilateral mild to moderate hearing loss
- •Experienced users must have at least 6 months Hearing Aid experience
- •New users must have no prior hearing aid experience, defined as never owning their own devices
排除标准
- •Self-reported ear related pathology (otorrhea w/in 90 days, dizziness, sudden hearing loss or worsening of hearing w/in 90 days, otalgia)
- •Visible deformity of the ear
- •Chronic, severe tinnitus
- •Unilateral hearing loss
- •Cognitive impairment
结局指标
主要结局
Quick Speech in Noise Test (QuickSIN)
时间窗: Day 1 of 1 day study
A speech in noise test in which participant repeats sentences in variable levels of background noise. Test result is reported as the signal to noise level at which participant can repeat 50% of the words correctly. A lower score/dB SNR (decibel Signal to Noise Ratio) level indicates better speech in noise perception. For example, a score of 0 dB would indicate that the participant can repeat 50% of the words presented when the speech signal and the noise are presented at the same level. A score of 6 dB would indicate that the participant needs the speech signal 6 dB louder than the noise in order to correctly repeat 50% of the words presented. Scores can range from negative db SNR (e.g. -5 dB, which would be a good score and indicate little difficulty in noise) to quite high (e.g. +15 dB, which would be a poorer score and indicate much difficulty in noise) In this case, the scores ranged from +2 to +18 dB.
次要结局
未报告次要终点