A Comparative, Controlled, Clinical Investigation and Quality Control of a New Hearing Aid in Comparison to the Currently Marketed Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bernafon AG
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Speech Intelligibility Performance
研究概览
简要总结
The aim of this study is to investigate the performance of the hearing aid under laboratory as well as everyday conditions. In addition, the performance data of the hearing aid are compared with a Bernafon hearing aid already available on the market.
The hearing aids are adapted according to the user requirements. The data collected in the study is intended to show that the benefit of the hearing aid being examined is identical or better than the current CE-marked hearing aid. A further aim is to improve the adaptation of the hearing device in such a way that the benefit for people with hearing impairments can be increased.
详细描述
The reason for this study is to evaluate a new hearing aid. The goal is to evaluate the audiological performance and usability as well as features and functions in comparison to the hearing aid already CE marked. Furthermore, it is important to identify unexpected or unwanted behavior from the devices. This clinical investigation is a validation testing and is designed to evaluate the new hearing instrument system. As human subjects are involved, this validation test falls under the definition of a clinical investigation. The validation addresses the performance of the device with new functionality, and additionally addresses whether the end user can understand speech as well as with the current marketed device.
End users will be tested in the lab with speech tests and usability tests. They will also participate in field tests after which they will answer questionnaires concerning their experience with the instruments. Evaluating the overall performance of the hearing instrument is important to verify that the end user is satisfied with the device and that all user requirements are fulfilled. Many of the features available in the new device have already been validated and are used in devices currently on the market.
The purpose of this research is to show that the performance of the new device is as good as or better than the current device. Furthermore, speech should not be negatively affected with the addition of new features, the usability of the devices (that end users are able to handle the devices) should be as good as the current device, and there should be no artifacts or unwanted noises. Some measurements serve as quality control prior to product launch.
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 hardware will be obviously different from the control devices and impossible to blind.
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)
- •If the hearing loss is conductive or mixed it must be approved for amplification by a physician
- •All shapes of hearing loss (flat, sloping, reverse slope, notch)
- •Severity ranging from mild to severe
- •German speaking
- •Ability and willingness to sign the consent form
排除标准
- •Contraindications for amplification
- •Active ear disease
- •Inability to follow the procedures of the study due to language problems, psychological disorders, dementia, or other cognitive problems of the participant,
- •A reduced mobility making them unable to attend weekly study appointments
- •A reduced ability to describe auditory impressions and the usage of the hearing aids
- •Uncooperative so that it is not possible to record a valid pure tone audiogram
- •A strongly reduced dexterity
- •Central hearing disorders
- •Bernafon employees
- •Family members of Bernafon employees
结局指标
主要结局
Speech Intelligibility Performance
时间窗: 2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks.
Speech test scores will be measured with speech reception thresholds (SRTs) of speech in noise in three conditions: unaided, aided with the current device, and aided with the new device. The score is measured by the the signal-to-noise ratio (SNR) at which 50% of words in a sentence list are correctly repeated. The speech is always presented at 65 dB and the background noise varies to maintain the 50% correct. A lower SNR score indicates a better score. The maximum score will be 15 dB and the minimum will be -5 dB.
次要结局
- Subjective Performance of Aided Benefit(A 2 week time period during which they will wear the devices and answer questionnaires about the experience.)
- Speech Intelligibility Performance With New Feature(2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks.)
- Events(A 2 hour period of interviews and questionnaires after having worn the devices for approximately 2 weeks and keeping a diary to make notes of device behavior.)
- Handling/Usability Performance(2 hour period of usability testing with tasks and questionnaires.)