Comparison of Hearing Aid Fitting Outcomes Between Self-fit and Professional Fit for MDHearing Smart Hearing Aids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Number of Participants With Improvement at 1 Month as Measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB) and Speech Spatial Qualities 12 (SSQ 12) Scale.
研究概览
简要总结
Hearing aids are commonly used to help people with hearing loss hear better in daily listening environments. MDHearing Smart hearing aids are designed to use the MDHearing app to adjust hearing aids to each individual's hearing loss. This study intends to show whether the MDHearing Smart hearing aids can be fitted by each user reliably and if each user can use the MDHearing app on their smartphone or tablet to make adjustments to achieve good aided benefit, which will be compared to those fitted by audiology professionals. This study includes three components: human factor study, self-fit study, and professional-fit study. The information obtained will be useful for both audiology professionals and people with impaired hearing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Over 18 years old
- •At least one air conduction threshold above 15dB HL.
- •All air conduction thresholds must be under 60dB HL
排除标准
- •Signs of outer or middle ear pathology
- •Greater than 60db HL hearing loss at any frequency.
结局指标
主要结局
Number of Participants With Improvement at 1 Month as Measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB) and Speech Spatial Qualities 12 (SSQ 12) Scale.
时间窗: 1 month
Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB) and Speech Spatial Qualities 12 (SSQ 12). The lowest possible score on the APHAB is 1% with the highest score being 99%. A higher score indicates improvement. On the SSQ, the scores range from 0 to 10 with a higher score indicating hearing perfectly in that situation. For the SSQ Part B, the scores range from -5 to +5 with a higher score indicating improved hearing for that situation.
Human Factors Study: Percentage of Participants Able to Use Hearing Aids Both With and Without Guidance.
时间窗: 1 hour
Subjects are able to use the hearing aids while using the app and manuals as guidance. Ease of use will be self reported by the subjects as to whether the task was able to be completed without guidance, able to be completed with guidance from the manual, or unable to be completed. Participants self-reported their comfort level with hearing aids and with technology in general. Participants sat with a researcher to note if tasks were able to be completed without guidance, with guidance from the manual, or unable to be completed. This group was separate from the Self Fit group and the Professional Group.
次要结局
未报告次要终点