A Comparative, Controlled, Clinical Investigation of a Currently Marketed Hearing Aid When Programmed With Two Different Fitting Methods
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Bernafon AG
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- Assessment of subjective benefit with the standardized questionnaire, International Outcome Inventory For Hearing Aids (IOI-HA)
研究概览
简要总结
This study is designed to investigate the benefits of the hearing aid in the laboratory and in daily life when fitted with two different methods. Subjective and objective evaluations will be made. The aim is to show the benefits of the hearing aids with both fitting methods with the help of data obtained, and to improve the available fitting methods in order to further increase the benefit for people with hearing disorders in situations where the standard method and those trained to perform it are not available.
详细描述
Benefits of amplification and accessories used with it outweigh anticipated risks in mild to profound hearing impaired subjects. The basic benefit of amplification should be present with any method that the trained professional fitting the instruments uses. The goal of this study is to compare two fitting methods and determine whether the end user perceives more benefit from one fitting method over the other. The objective benefit is expected to be the same; however, the subjective benefit may be different due to a possible psychological effect from more effort or time spent by the trained professional.
Bernafon will conduct this clinical investigation to test current hearing instruments fitted with the standard procedure and a self-directed procedure. Safety and performance validation of the new self-directed fitting software is needed before release to the market.
The reason for this study is to evaluate a currently marketed, CE certified, hearing aid and determine whether different fitting methods provide the same perceived benefit. Additionally, this study will validate the safety of the fitting procedure as well as collect post market safety information about the devices themselves. The goal is to evaluate the audiological performance objectively as well as the subjective benefit. Furthermore, it is important to identify unexpected, unwanted behavior from the fitting software and the devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
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 types of hearing loss (sensorineural, conductive, mixed)
- •If the hearing loss is conductive or mixed it must first be approved for amplification by a physician
- •All shapes of hearing loss (flat, sloping, reverse slope, notch)
- •Severity ranging from mild to severe
- •First time hearing aid users (never worn hearing aids before)
- •German speaking
- •Both genders
- •Ages 18 and older
- •Ability and willingness to sign the consent form
排除标准
- •Current hearing aids users
- •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 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
- •With psychological problems
- •Central hearing disorders
- •Bernafon employees
- •Family members of Bernafon employees
研究组 & 干预措施
Fitting System
a self-directed hearing screening based on a known algorithm from Audiology Inc. sold in an automated audiogram by Grason Stadler, GSI and a simplified version of the software. The flow of the new software is driven by the end user, but a trained professional should always assist with the fitting. The new software will first perform a hearing screening on the end user and then recommend a hearing aid and prescribe amplification to the hearing aid based on the hearing screening results.
干预措施: Fitting System (Device)
Traditional Fitting System
A traditional fitting method will be used as a control. This system is controlled by a trained professional, who performs the entire fitting without much interaction from the end user. The hearing instruments will be fit with the same settings as the experimental arm.
干预措施: Traditional Fitting System (Device)
结局指标
主要结局
Assessment of subjective benefit with the standardized questionnaire, International Outcome Inventory For Hearing Aids (IOI-HA)
时间窗: Time frame to assess change is one month with the first measure after two weeks and the second week 3-4
The answers to the questionnaire will be compared for each fitting method to determine if the subjective hearing aid benefit is as good when using the IMD as with the RMD. There is no numerical outcome.
次要结局
- Assessment of speech understanding with a standardized speech test that uses the percentage of words correct to score the performance.(Time frame to assess change is one month with the first measure after two weeks and the second week 3-4)
- Assessment of hearing aid preference with a questionnaire(Time frame to assess change is one month after the hearing aids have been worn with both fitting methods.)