REFIT Hearing: Remote Fitting of Hearing Aids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- speech perception
研究概览
简要总结
Currently, the fitting of hearing aids is using a computer interface that allows to adjust the gain and compression of acoustic amplification. This adjustment is made face to face, patient and audiologist being located in a soundproof space to test the effectiveness of the hearing aid.
However, advances in telemedicine in this context, let consider the possibility of addressing these hearing aids fitting via the same computer interface, but remotely controlled by the hearing care professional. The purpose of this study is to assess the ability to perform these tests no longer in front of the patient settings, but away from it, and without visual and sound contact other than through a computer interface.
At the end, this project wants to show that a remote fitting is an acceptable procedure that provides comparable results to-face fitting in terms of speech perception, speech in noise audiometry, hearing loss related quality of life in order to be able to offer this type of strategy.
详细描述
- Background and rationale:
Currently, the fitting of hearing aids is using a computer interface that allows to adjust the gain and compression of acoustic amplification. This adjustment is made face to face, patient and audiologist being located in a soundproof space to test the effectiveness of the hearing aid.
However, advances in telemedicine in this context, let consider the possibility of addressing these hearing aids fitting via the same computer interface, but remotely controlled by the hearing care professional. The purpose of this study is to assess the ability to perform these tests no longer in front of the patient settings, but away from it, and without visual and sound contact other than through a computer interface. 2. Objectives Main objective: To show that the remote fitting of hearing aids using the platform developed by AudioProConnect provides speech perception scores similar to those obtained by a face-control, after 5 weeks of use among experienced hearing aid users.
Secondary Objectives: To compare the duration and the quality of both types of fitting, speech in noise testing, deafness related quality of life and assess the wearing time of hearing aids. 3. Methods DESIGN: Biomedical research on health product, prospective, multicenter, randomized, and crossover study to assess the remote fitting of hearing aids: Study REFIT-HEARING Study Population: adults with bilateral hearing aids. Inclusion criteria: Patient aged between 18 and 85 years old, with hearing loss and using two hearing aids for more than one year, and compatible with AudioProConnect platform.
Exclusion criteria: Patient with fluctuations of pure tone audiometry, cognitive disorders or severe speech disorders. Patient unable to move in an audiology laboratory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age limits ≥ 18 et < 85 years
- •User of two hearing aids for more than a year
- •Carriers of adjustable digital hearing aids by means of a software of the usable manufacturer on Windows® PC (in stand-alone or as plug-in in the software NOAH®) to be integrated into the platform AudioProConnect. It is the case of almost all the current hearing aids (Phonak, Starkey, Siemens, Unitron, etc.)
- •Subject able to understand the nature, the aim and the methodology of the study.
- •Affiliation or recipient with the mode of social security.
- •Collection of the informed consent
排除标准
- •Fluctuations in the tonal audiometry, defined as variations furthermore of 10 dB of the average hearing loss (Average arithmetic of thresholds in 500, 1000, 2000 et 4000 Hz) Between the last 2 tonal audiometries realized over the previous 2 years
- •Cognitive disorders or severe phasic hampering the understanding of the language or the repetition of the speech (Subject not being capable of participating in a vocal audiometry during the last regulation of its hearing aids)
- •Incapacitated to move in a laboratory of audioprosthesis
- •Fickle bearing of the hearing aid (<6h /day ou < 5day/7)
- •Tip not adapted little finger
- •Presence of plugs of earwax at the time of the tests
- •Patient minor(miner) or protected adults or in the incapacity to give its consent according to the article L1121-8 Of the Public Code of the Health (CSP)
- •Pregnant or breast-feeding women according to the article L1121-5 du CSP.
- •Vulnerable people according to the article L1121-6 du CSP.
研究组 & 干预措施
face to face fitting
face to face fitting of hearing aids
干预措施: Remote fitting (Device)
face to face fitting
face to face fitting of hearing aids
干预措施: Face to face fitting (Device)
remote fitting
remote fitting of hearing aids
干预措施: Remote fitting (Device)
remote fitting
remote fitting of hearing aids
干预措施: Face to face fitting (Device)
结局指标
主要结局
speech perception
时间窗: 5 months
score PBK test
次要结局
- speech in noise audiometry(5 months)
- quality of life(5 months)
- daily use of hearing aids(5 months)
- duration of fitting(5 months)