Validation of 2 Novel BTE Hearing Aid Models Varying With Respect to Regular-power or Super-power Gain Specifications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Number of Participants With 'Total Impression' Sound Quality as 'Good'
研究概览
简要总结
Participants will wear one set of 2 different BTE hearing aid models based on the gain required by their hearing loss. The hearing aids will be programmed based on a prescriptive approach and participants will be sent out for either one home trial with the less powerful BTEs or for two home trials with the SP (super power) BTEs.
详细描述
During this study each participant will be asked to wear a set of BTE hearing aids home and wear them daily. We will be assessing their evaluation of the BTEs during and after their home field trial. They will be asked to report on their use with different apps/accessories. Subjective performance ratings will be collected.
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
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hearing aid candidacy (N2-N7 hearing loss)
- •healthy outer and middle ears
- •ability to complete questionnaires
- •willingness to use smartphone
- •informed consent documented by a signature
- •willingness to wear a binaural BTE fitting
- •willingness to use app and accessories
- •willingness to adhere to COVID protocols
排除标准
- •contraindications to the MD in this study: known hypersensitivity or allergy to investigational product/earmold
- •limited mobility/not able to attend appointments
- •limited ability to describe listening impressions/experiences
- •inability to produce a reliable hearing test result
- •limited dexterity - to point that participant cannot manage hearing aid insertion/removal
- •known psychological disorders
研究组 & 干预措施
BTE hearing aid model
BTE or SP-BTE (super power) hearing aid fitting
干预措施: BTE hearing aid (Device)
结局指标
主要结局
Number of Participants With 'Total Impression' Sound Quality as 'Good'
时间窗: final appointment (end of 3 weeks home trial for BTE model, end of 7 weeks home trial for SP-BTE model)
Participants with 'good' response of 7 or higher on 'Total Impression' scale; Gabrielsson citation/article includes seven perceptual scales and a scale for 'Total Impression' which is described as 'an overall judgment of how good you think the reproduction is'. Possible scores from 0 to 10 with descriptors provided: 0 (min), 1 (very bad), 3 (rather bad), 5 (midway), 7 (rather good), 9 (very good), 10 (max) A higher score reflects a better outcome.
次要结局
- Number and Percentage of Participants Reporting No Reboots(at any time during home trial, reported at or by final appointment(end of 3 weeks home trial for BTE model, end of 7 weeks home trial for SP-BTE model))
- Number of Participants Reporting Perceived Differences With Both of the App Boost Controls(initial appointment (day of fitting of hearing aids))
- Number of Participants Reporting Perceived Differences With Both of the App Slider Controls(initial appointment (day of fitting of hearing aids))