Evaluate the Benefit of a BiCROS Hearing Aid Fitting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Speech Intelligibility in Noise Measured With US Matrix Test (Noise From a Defined Loudspeaker)
研究概览
简要总结
22 candidates for BiCROS hearing aids will be recruited and fitted with a hearing aid and a CROS device. Following a real-world trial, each participant will be tested on a range of outcome measures including speech recognition in noise, ratings of listening effort, and ratings of preference.
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.
Hearing tests, ear impressions and hearing aid fitting visits are mainly conducted at the National Centre for Audiology in London, Ontario. Those visits are available at the Sonova Innovation Centre Toronto in Mississauga, Ontario, upon request. Outcome measurements are only conducted at the National Centre for Audiology in London, Ontario.
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
盲法说明
Participants were wearing the BiCROS fitting during home trial, where no masking was possible. For in-lab tests, the CROS device was deactivated for the monaural condition, allowing for some masking. The unaided condition could not be masked. Participants were not aware which beamformer configuration was active during in-lab tests.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •unaidable hearing loss in worse ear (>N6)
- •aidable hearing loss (N3 to N5) on the other ear
- •fluent English speaker
排除标准
- •aidable hearing loss in both ears
结局指标
主要结局
Speech Intelligibility in Noise Measured With US Matrix Test (Noise From a Defined Loudspeaker)
时间窗: At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting
Measuring the Signal to Noise Ratio change in decibels (dB) for speech from the front loudspeaker and noise from the better ear's side with the US matrix Test. 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 65 dB (A).
次要结局
- Speech Intelligibility in Noise Measured With US Matrix Test (Diffuse Noise)(At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting)
- Reports of Subjective Quality of Hearing as Assessed by the SSQ(At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting)
- Reports of Subjective Quality of Hearing as Assessed by the Bern Benefit Questionnaires(At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting)
- Sound Quality Ratings for Total Impression and Clarity Using Gabriellson et al (1990) Ratings Scales(At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting)
- Subjective Preference of Hearing Aid Condition(At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting)
- Listening Effort in Noise Using 7 Point Scale (Holmes et. al., 2018)(At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting)