Evaluation of New Custom Made Hearing Product Technology and Shell Modification
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Objective measurement from the position of the outer ear related to the test subject.
研究概览
简要总结
The purpose of this evaluation is to receive the greatest benefit of new custom made hearing product technology and shell modification for the end customer and to continual improve the custom made hearing products.
详细描述
This is a controlled, single blinded comparative study which is conducted monocentric at Phonak Headquarters in Staefa.
The purpose of the studies is to evaluate the strengths and weaknesses of new custom product development in comparison to existing/old products. The results should promote the custom product development, to provide a maximum of benefit and wearing comfort to the hearing aid user.
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
- Single (Participant)
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
- •Only adult participants between 18 and 99 years
- •lnformed Consent as documented by signature (Appendix lnformed Consent Form)
- •Ability to fill in a questionnaire conscientious
- •Healthy outer ear (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,
- •Limited mobility and not in the position to attend weekly appointments
- •Limited ability to describe listening impressions/experiences and the use of the hearing aid
- •lnability to produce a reliable hearing test result when pure tone audiometry is attempted by the audiologist
- •Massively limited dexterity
- •Psychological problems
- •Central hearing problems
研究组 & 干预措施
Hearing Device Type A
In the ear (ITE) hearing aid, 1-3 weeks wearing
干预措施: hearing aid (MD class IIa) - ITE, BTE, RIC (Device)
Hearing Device Type B
In the ear (ITE) hearing aid, 1-3 weeks wearing
干预措施: hearing aid (MD class IIa) - ITE, BTE, RIC (Device)
结局指标
主要结局
Objective measurement from the position of the outer ear related to the test subject.
时间窗: 5 years
Measurement in degree.
Objective measurement from the size of the outer ear related to the test subject.
时间窗: 5 years
Measurement in micron.
Objective measurement of humidity in the ear canal related to the test subject and the intervention.
时间窗: 5 years
Measurement in percent.
Objective measurement of speech intelligibility related to the intervention.
时间窗: 5 years
SNR (speech to noise ratio) in decibel.
Objective measurement of the transfer function related to the intervention.
时间窗: 5 years
REM (real ear measurement) in decibel.
Objective measurement of temperature in the ear canal related to the test subject and the intervention.
时间窗: 5 years
Measurement in degree centigrade.
次要结局
- Subjective rating of the intervention via questionnaire.(5 years)