Benchmark Ear Impression Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Deviation of Direct ear scanner compared to silicone impressions
研究概览
简要总结
The purpose of this study is to determine the scan quality of the direct ear scanner concerning consistency, accuracy and reliability and to compare the data to common silicone ear impressions by benchmarking the outcome of each impression technique on custom product dummies on participants.
详细描述
Today's standard for ear impression techniques is the impression taking process with silicone impression material. To use the silicone impression for a hearing aid manufacturing process the geometry of the impression is needed. Modern processes scan the silicone ear impression with specific scanners. Afterwards the digitalized ear impression is uploaded in the modeling software for further proceed. A new ear impression technique is now provided with the direct ear scanner technology. The direct ear scanner can create a digital scan of the outer ear and ear canal. The scan than can directly transferred to the modeling software. The research question of this study is to determine the scan quality of the direct ear scanner concerning consistency, accuracy and reliability and to compare the data to common silicone ear impressions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •Only adult participants ≥ 18 years
- •Informed consent form as documented by signature
- •Ability to fill in a questionnaire conscientious
- •Healthy outer ear (Pinna and ear canal, w/o previous surgical procedures)
排除标准
- •Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
研究组 & 干预措施
Direct Ear Scanner
Digitale impression via direct ear scanner
干预措施: Direct Ear Scanner (Device)
Silicone Ear impression
Impression via silicone
干预措施: Standard Impression technique (Device)
结局指标
主要结局
Deviation of Direct ear scanner compared to silicone impressions
时间窗: 1 year
Deviation of the scan of Direct ear scanner compared to silicone impressions with two viscosities \[mm\]
次要结局
未报告次要终点