A Clinical Investigation Comparing a Standard Hearing Aid Fitting Protocol and a Fitting Protocol Optimized for Musicians
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bernafon AG
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Preference Rating
研究概览
简要总结
The trial will test whether a standard music program that is an offset to the general program provides the same benefit as a music program that is individually customized for each test participant. The trial seeks to investigate the benefit received by musicians that regularly play an instrument and belong to an organized music group or orchestra instead of people that listen to music.
详细描述
The initial goal of hearing aids is to amplify speech and facilitate speech understanding especially in noise. Besides speech difficulty, people with hearing loss also report a reduced enjoyment of music. The hearing aid settings used for amplifying speech often have adverse effects on music.
For this study, the sponsor will carry out testing with participants with hearing loss to compare dedicated music programs. The current study will compare the standard music program available in the software to one that is fine-tuned for each subject. The hearing aids that will be used for the study are certified by the European Conformity and have been on the market for almost one year. The goal is to determine whether musicians will perceive a difference and prefer a fine-tuned music program over the default music program in real-life situations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The allotted program position for the music programs will be randomized. Half of the participants will have the fine-tuned program in slot 2 and half will have it in slot 3. They will not know in which position the fine-tuned program is versus the standard program.
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
- •All classifications of hearing loss (sensorineural, conductive, mixed)
- •If conductive or mixed, approval for amplification by a physician is needed
- •All shapes of hearing loss (flat, sloping, reverse slope, notch)
- •Severity ranging from mild to profound
- •German or French speaking
- •Play a musical instrument
- •Ability and willingness to sign the consent form
排除标准
- •Normal hearing
- •Contraindications for amplification
- •Active ear disease
- •Don't play an instrument
- •Inability to follow the study procedures due to language problems, psychological disorders, dementia, or other cognitive problems
- •Unable to attend study appointments due to reduced mobility
- •Reduced ability to describe auditory impressions and usage of hearing aids
- •Uncooperative so that it is ot possible to record a valid audiogram
- •Severely reduced dexterity
- •Central hearing disorders
- •Sponsor employees
- •Family members of employees of the Sponsor
结局指标
主要结局
Preference Rating
时间窗: 20 days
Subjects will answer a questionnaire that asks them to choose which program that they preferred. The questionnaire gives Program 1 or Program 2 as the choices as well as a no Preference option for those that did not notice a difference between the two. The percentage of subjects that chose each Program will be calculated to determine if more preferred the optimized music program.
次要结局
- Sound Perception Test - Pitch(0,10, and 20 days)
- Music Sound Quality Rating(0,10, and 20 days)
- Sound Perception Test - Duration(0,10, and 20 days)
- Sound Perception Test - Brightness(0,10, and 20 days)
- Sound Perception Test - Level(0,10, and 20 days)
- Sound Perception Test - Attack(0,10, and 20 days)
- Sound Perception Test - Spectral Irregularities(0,10, and 20 days)