MED-EL HEARING SOLUTIONS (MEHS): AN OBSERVATIONAL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 16
- 主要终点
- Hearing Threshold level
研究概览
简要总结
This Registry represents a non-interventional systematic collection of clinical data in which prospective data from children and adults are collected as fully anonymized data sets, derived from original clinical records on appropriately informed subjects.
This is a patient-outcomes Registry for subjects of any age who are provided in routine clinical practice with one or more MED-EL hearing devices. The Registry aims to collect data for hypothesis generation on subject device use, auditory performance, quality of life and health-related utilities, across different types of implantable and non-implantable hearing devices from MED-EL company. Subjects will be evaluated with a set of standardized tests and questionnaires prior to implantation or prior to initial device activation (baseline) and at follow-up intervals according to the clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For children and adults receiving an implant: Subjects submitted or planned to be submitted to unilateral or bilateral implantation, using simultaneous or sequential procedures.
- •For children and adults receiving a non-implantable device: Subjects submitted or planned to be submitted to unilateral or bilateral treatment with a non-implantable device from MED-EL.
- •Unilateral, bilateral or bimodal users (children and adults) of cochlear implants (CIs), electric-acoustic devices, bone conduction implants, middle ear implants or any other implantable or non-implantable hearing solution from MED-EL.
- •Signed written informed consent for data collection for Registry purposes.
排除标准
- •Lack of compliance with any inclusion criteria.
- •Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the Registry procedures
结局指标
主要结局
Hearing Threshold level
时间窗: 5 years
Audiometry testing (unaided)
Speech test
时间窗: 5 years
Results from speech tests
HISQUI (Hearing Implant Sound Quality Index)
时间窗: 5 years
Results from the HISQUI questionnaire
Subject Demographics
时间窗: 5 years
APHAB (Abbreviated Profile of Hearing Aid Benefit)
时间窗: 5 years
Results from the APHAB questionnaire
ASC (Auditory Skills Checklist)
时间窗: 5 years
Results from the ASC questionnaire
APSQ (Audio Processor Satisfaction Questionnaire)
时间窗: 5 years
Results from the APSQ questionnaire
LEAQ (LittlEars Auditory Questionnaire)
时间窗: 5 years
Results from the LEAQ questionnaire
HL-QOL
时间窗: 5 years
Results from the HL-QOL questionnaire
次要结局
未报告次要终点