Characterizing Variability in Hearing Aid Outcomes Among Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Speech intelligibility
研究概览
简要总结
This translational project aims to optimize the fitting of hearing aids by development and clinical validation of a toolset that guides signal processing choice based on the individual auditory and cognitive abilities of the patient.
详细描述
The clinical trial portion of the project will validate clinical use of the toolset by evaluating a population of patients fit using current standard of care. Patient characteristics, such as audiological profile and cognition, will be collected. Their hearing aid settings will then be evaluated to determine if they meet toolset guidelines for signal processing based on their patient characteristics (auditory and cognition). Data regarding subjective and objective hearing aid outcomes will also be collected. It is hypothesized that hearing aid fittings that meet the standards of the proposed clinical toolset will result in better patient outcomes (objective and subjective) and fewer post-fitting visits.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sensorineural hearing loss with pure-tone thresholds 70 dB HL or better at octave frequencies between 250 and 4000 Hz, 4 (.5, 1, 2, 3 kHz)
- •frequency pure-tone average (PTA) of ≥ 30 dB HL.
- •Listeners will have symmetrical losses, defined here as a 4-frequency PTA difference between ears ≤ 20 dB HL.
排除标准
- •recent (within last 12 months) hearing aid use
- •conductive loss (air-bone gaps > 10 dB at any frequency and/or abnormal immittance) -
- •scoring < 23 on the Montreal Cognitive Assessment
- •Hearing loss exceeding the limits that can be successfully aided with hearing aids (i.e., profound hearing loss)
- •Hearing loss remediated with a cochlear implant (cannot wear hearing aids)
- •Significant history of otologic or neurologic disorders
- •Non English speaking participants
- •Any clinically significant unstable or progressive medical condition
- •Any condition which, in the opinion of the investigator, places the participant at unacceptable risk if he or she were to participate in the study.
结局指标
主要结局
Speech intelligibility
时间窗: Baseline at initial fit, then post-intervention at final hearing aid appointment, about 30 days later
Repeat low-context sentences
次要结局
- Post-fitting adjustment visits(First 30 days of fitting)
- Speech and Spatial qualities questionnaire (SSQ)(Baseline at initial fit, then post intervention at final hearing aid appointment, about 30 days later)
研究者
Pamela Souza
Professor
Northwestern University