3D Ear Scanner-Workflow Timing and Preferences Compared to Traditional Silicone Earmold Impressions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Elapsed Time in Minutes to Complete Bilateral Ear Impressions
研究概览
简要总结
Study participants will undergo ear canal impressions in a standard of care protocol utilizing two methodologies: 3D ear scanning using a commercially-available ear scanning device, and conventional silicone impression material. The elapsed time of each procedure will be captured for each participant, and the average duration of the two methodologies will be compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hearing impairment (any degree, type, and configuration)
排除标准
- •Absent or abnormal external auditory canal and/or external auditory meatus.
- •Positive history of external/middle ear surgery.
结局指标
主要结局
Elapsed Time in Minutes to Complete Bilateral Ear Impressions
时间窗: Day one
The total time in minutes, required for sub-investigators to complete each impression methodology on each participant, according to a standard of care procedure . For the silicone impressions, time was started after otoscopy and cerumen management of both ears, and just before prepping and placing the otoblocks. The timer stopped after the audiologist was satisfied with both ear impressions and placed them in box. For the ear scan, time was started after otoscopy of both ears, and just before prepping the headset and hand-held scanner. The timer stopped after the 3D scan was reviewed for each ear and audiologist satisfied with result. The time reported is how long it took for clinician to finish one complete set of impressions, which included a right and a left ear impression. Separate times for each ear was not recorded.
次要结局
- Sub-investigator Clinician Subjective Rating of Individual Confidence That Method of Impression Will Yield a Quality Custom Product for the Participant on a Scale From 1 (Not at All Confident) to 3 (Very Confident).(Day 1)
- Subjective Feedback, Pleasantness of Experience(Day one)
- Sub-investigator Clinician Subjective Rating of Ease of Procedure on a Scale From 1 (Not at All Easy) to 10 (Most Ease)(Day 1)
- Sub-investigator Clinician Subjective Rating of Individual Potential for Improvement When Performing Each Procedure 1 (no Potential for Improvement) to 3 (a Lot of Potential for Improvement)(Day 1)
- Subjective Feedback on the Perceived Improvement of Actual Device Fitting Using Each Impression Procedure Compared to a Non-custom Hearing Aid Fitting(Day one)
- Clinician Subjective Rating of Overall Experience of Each Procedure.(Day 1)
- Subjective Feedback of Overall Experience of Both Ear Impression Procedures(Day one)