A Comparative, Controlled Clinical Investigation of a New Acoustic Feedback Cancellation Strategy in Comparison With the Currently Marketed System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bernafon AG
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Change in Live Feedback Test Scores From Day 10 to Day 20
研究概览
简要总结
The Purpose of the study is to show that the performance of the new feedback cancellation system is better than the feedback system used in the currently marketed hearing aids. Speech understanding should not be negatively affected by the new system, ad there should be no consequential artifacts or unwanted noises caused by the new system.
详细描述
The amplification of sounds with a hearing aid is the most common treatment for hearing loss. Benefits of amplification and accessories used with it outweigh any risks in mild to profound hearing-impaired subjects. Hearing aids provide a benefit for people with only a mild sensorineural hearing loss. However, often people are counselled to wait to purchase hearing aids until their hearing loss becomes more significant. The benefits are obtainable for both unilateral and bilateral fittings and are both short term and durable on long term.
Acoustic feedback is a critical problem to all hearing aids. The acoustic coupling between the hearing aid receiver and the microphone occurs when an endless loop is formed so that the microphone is re-amplifying sound from its own receiver. The higher the amplification of the system, the more unstable it becomes and the more likely an acoustic feedback will occur. When this happens the hearing aid user and those around them hear a loud whistling noise. A common method used to combat this problem is feedback cancellation, more specifically adaptive feedback cancellation. The goal of feedback cancellation is to quickly identify feedback path changes and make adjustments to preserve the stability of the system while maintaining a high sound quality and still providing a high stable gain compared to the gain achieved without an active feedback reduction.
For this study, the Sponsor will carry out testing with participants who have hearing loss to validate the performance of the new feedback cancelling algorithm. Studies have investigated the advantages and disadvantages of different feedback cancellation techniques. However, it is accepted by professionals that having a feedback system is better than not using feedback cancellation. The Sponsor has used an adaptive feedback cancellation algorithm since 2010. For the current study the new adaptive algorithm will be compared to the current algorithm implemented in the hearing aids that are certified by the European Conformity and sold on the market. The aim is to determine if less feedback is experienced using the new system in comparison to the old system.
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
The participants are masked during the lab testing. They will not know which device they are testing because the Investigator will place it on their ear without letting them see it.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All classifications of hearing loss (sensorineural, conductive, mixed)
- •Conductive and mixed hearing loss must be approved for amplification by a physician
- •All shapes of hearing loss (flat, sloping, reverse slope, notch)
- •Severity ranging from mild to profound
- •German speaking
- •Ability and willingness to sign the consent form
排除标准
- •Contraindications for amplification
- •Active ear disease
- •New hearing aid users
- •Inability to follow the procedures
- •Reduced mobility that makes then unable to attend study Appointments
- •Uncooperative so that it's not possible to get a valid audiogram
- •A strongly reduced dexterity
- •Central hearing disorder
- •Sponsor employees
- •Family members of Sponsor employees
结局指标
主要结局
Change in Live Feedback Test Scores From Day 10 to Day 20
时间窗: 10 days, 20 days
In the lab, subjects will have the hearing aid placed in their ear. They will rate on a visual analogue scale whether feedback occurs and if so, how much annoyance it causes. The scale has a minimum of 0 and a maximum of 10. A lower score is a better answer. It will be tested in two conditions, aided with the current Hearing aid, and aided with the new Hearing aid at 10 and 20 days. The difference between the scores from day 10 and day 20 was calculated by subtracting day 20 ("new hearing aid") from day 10 ("current hearing aid") after both sessions of testing were completed and reported as the mean difference for the group. Regardless of the arm assignment, participants wore the same hearing aids for the lab test on days 10 and 20.
次要结局
- Word Recognition - Aided(20 days)
- Sound Quality Rating(20 days)
- Word Recognition - Unaided(10 days)