A Study to Compare Patient Perceptions of Two Different Hearing Aid Signal Processing Philosophies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for First Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B
研究概览
简要总结
Participants will be fit with each of two hearing instruments in an ABA cross-over design. The study will consist of a total of three approximately 10-day home trials with the devices. Participants will be asked to provide qualitative feedback to investigators regarding the performance of and their preference for each hearing instrument.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Identifying information will be removed from the hearing instruments before fitting the participants. However, participants may be able to research hearing instruments and identify devices based on physical appearance.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Moderate to severe sensorineural hearing loss
- •Current hearing aid user
排除标准
- •Lack of willingness to wear study devices for approximately one month
- •Inability to travel to study appointments or to complete questionnaires.
研究组 & 干预措施
A-B-A
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument A Hearing instrument B Hearing instrument A
干预措施: Receiver-in-canal hearing instrument; Manufacturer A (Device)
A-B-A
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument A Hearing instrument B Hearing instrument A
干预措施: Receiver-in-canal hearing instrument; Manufacturer B (Device)
B-A-B
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument B Hearing instrument A Hearing instrument B
干预措施: Receiver-in-canal hearing instrument; Manufacturer A (Device)
B-A-B
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument B Hearing instrument A Hearing instrument B
干预措施: Receiver-in-canal hearing instrument; Manufacturer B (Device)
结局指标
主要结局
Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for First Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B
时间窗: End of home trial 1 (Day 10 of study)
Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10).
Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Third Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B
时间窗: End of home trial 3 (30 days after study start)
Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10).
Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for First Study Set Worn.
时间窗: End of home trial 1 (Day 10 of study)
Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral. .
Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Second Study Set Worn.
时间窗: End of home trial 2 (Day 20 of study)
Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral.
Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Second Study Set Worn, i.e. Study Set B for Arm A-B-A and Study Set A for Arm B-A-B
时间窗: End of home trial 2 (20 days after study start)
Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10).
Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Third Study Set Worn.
时间窗: End of home trial 3 (Day 30 of study)
Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral.
次要结局
未报告次要终点