Evaluation of the Clinical Benefit of a Transmitter for Contralateral Routing of Signals (CROS)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Sonova AG
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Speech Intelligibility (SI) in noise (fix direction): BiCROS fitting vs. monaural hearing aid fitting
研究概览
简要总结
This study will evaluate the clinical benefit of a transmitter for contralateral routing of signals. The benefit will be evaluated in noisy environments regarding speech intelligibility when the CROS system is adjusted to different microphone settings. Additionally, data regarding overall system stability, crash reboot rate, sound quality and connectivity will be obtained over a period of time to validate the CROS system in combination with smartphone and accessories. This study is a confirmatory study.
详细描述
Unilateral Hearing Loss (UHL) can be defined as any degree of permanent hearing loss on one ear with normal hearing in the opposite ear. Unilateral hearing loss can be debilitating associated with audiological, psychosocial and educational challenges. Audiological challenges include the reduced ability to localize sounds, reduced awareness on the unaidable side and difficulties hearing in noise or at a distance.
One solution for unaidable UHL is Contralateral Routing of Signals (CROS) and Bilateral Contralateral routing of signals (BiCROS) using a so- called CROS transmitter together with a hearing aid.
The rationale for this clinical investigation is to collect clinical data with a rechargeable CROS transmitter to evaluate the benefits of a BiCROS fitting compared to the alternative treatment option, the monaural hearing aid fitting, and to no treatment in noisy listening 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
- 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
- •hearing impaired adults, with & w/o hearing aids (experiences)
- •good written and spoken (Swiss) German language skills
- •ability to fill in a questionnaire conscientiously
- •informed consent as documented by signature
- •asymmetric hearing loss: one unaidable ear (min. N6 hearing loss) / the other ear with N3 or N4 hearing loss
- •availability of Smartphone
- •availability of TV or Tablet
- •ability to operate and handle the investigational device
- •ability to describe listening impressions/experiences and the use of the hearing aid
- •Ability to produce a reliable hearing test result
排除标准
- •Contraindications to the medical device:
- •aidable hearing loss on the intended CROS side
- •acute tinnitus (in either one ear and occurrence less than three months)
- •anatomical deformity of the CROS ear (e.g. absence of the auricle)
- •Known hypersensitivity or allergy to materials of the investigational device
- •any auricle deformities, that prevents secure placement of the (test) devices
- •no willingness to test the investigational device system
- •no willingness to test the investigational device system for at least 8h a day
- •Hint for psychological problems from investigators point of view
- •reported fluctuating hearing that could influence the test result
- •reported symptoms of vertigo and dizziness by participants
结局指标
主要结局
Speech Intelligibility (SI) in noise (fix direction): BiCROS fitting vs. monaural hearing aid fitting
时间窗: 2 weeks
The primary objective of this clinical investigation is to evaluate whether a BiCROS fitting (better ear fitted with a hearing device, unaidable ear supplied with a CROS device) improves speech intelligibility in noise compared to a monaural fitting (just the aidable ear is supplied by a hearing aid), for adults with an asymmetric hearing loss, measured with the Oldenburg Sentence Test (OLSA). Results of the speech test will be the SRT (speech recognition threshold) in dB SNR (signal to noise ratio). The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A). The noise will be presented on the better ear at an azimuth of 90° or 270° (depending on the site of the better ear), at a level of 70 dB (A).
次要结局
- SI in noise (fix direction): BiCROS fitting vs. unaided(2 week)
- SI in diffuse noise: CROS baseline fitting vs. unaided(2 weeks)
- SP in diffuse noise: monaural fitting vs. unaided(2 weeks)
- SI in diffuse noise: BiCROS fitting vs. unaided(2 weeks)
- SI in diffuse noise: CROS baseline fitting vs. monaural fitting(2 weeks)
- SI in diffuse noise: BiCROS fitting vs. monaural fitting(2 weeks)
- SI in diffuse noise: BiCROS vs. CROS baseline fitting(2 weeks)
- Evaluation of System stability(3 weeks)
- Evaluation of streaming(3 weeks)
- Evaluation of listening effort(3 weeks)
- Evaluation of Sound quality(3 weeks)