A Multicentre, Open, Long-term Clinical Investigation Evaluating Safety, Performance and Patient Reported Outcomes With an Active Osseointegrated Steady-State Implant System in Adult Subjects With Conductive Hearing Loss, Mixed Hearing Loss or Single-sided Sensorineural Deafness.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- Concomitant Medication Used
研究概览
简要总结
The aim of this clinical investigation is to collect long-term safety and performance data with the Active Osseointegrated Steady-State Implant System by following subjects from the previous Osia clinical investigation CBAS5751. In addition, questions regarding device satisfaction, sound satisfaction, usability and health care utilisation will be asked.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Subject has performed Hearing assessment at 3 and/or 6 months in the clinical investigation CBAS5751
- •Willing and able to provide written informed consent
排除标准
- •Unable to follow investigational procedures, e.g. to complete quality of life scales, or unwilling to comply with the requirements of the clinical investigation as determined by the investigator
- •Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator
结局指标
主要结局
Concomitant Medication Used
时间窗: 6 months post-surgery to 24 months post-surgery
Concomitant medication are collected from the participant's last visit in study CBAS5751 (6 months post-surgery)
Number and Type of Reported Device Deficiencies
时间窗: 6 months post-surgery to 24 months post-surgery
The device deficiencies are collected from the participant's last visit in study CBAS5751 (6 months post-surgery) and categorized by relationship
Change in Audiometric Thresholds With the Active Osseointegrated Steady-State Implant System at 12 Months Post-surgery and 24 Months Post-surgery Compared to Preoperative Thresholds Via an Audiogram
时间窗: Baseline before surgery, 12 months and 24 months post-surgery
Bone- and air conduction thresholds, masked and unmasked
Number and Type of Reported Adverse Events
时间窗: 6 months post-surgery to 24 months post-surgery
The adverse events are collected from the participant's last visit in study CBAS5751 (6 months post-surgery) and categorized by system organ class system
Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
时间窗: 24 months post-surgery
Demographic data (marital status, cohabitation, usual place of residence, education level), employment status, Healthcare utilization and Hearing rehabilitation data are collected
次要结局
- Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Audiometric Thresholds(3 or 6 months post-surgery, 12 and 24 months post-surgery)
- Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Adaptive Speech Recognition in Noise(3 or 6 months post-surgery, 12 and 24 months post-surgery)
- Magnet Choice of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study(3 or 6 months post-surgery, 12 and 24 months post-surgery)
- Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 Months and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Audiometric Thresholds(3 or 6 months post-surgery, 12 and 24 months post-surgery)
- Change in Health-related Quality of Life With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study(3 or 6 months post-surgery, 12 and 24 months post-surgery)
- Change in Self-reported Hearing Outcome With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study(3 or 6 months post-surgery, 12 and 24 months post-surgery)
- Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale(24 months post-surgery)
- Daily Use of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study(3 or 6 months post-surgery, 12 and 24 months post-surgery)
- Daily Streaming Time of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study(3 or 6 months post-surgery, 12 and 24 months post-surgery)
- Use of SoftWear Pad for the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study(3 or 6 months post-surgery, 12 and 24 months post-surgery)
- Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Bone Conduction (BC) Direct(3 or 6 months post-surgery, 12 and 24 months post-surgery)
- Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale(24 months post-surgery)
- Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale(24 months post-surgery)
- Retention of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study(3 or 6 months post-surgery, 12 and 24 months post-surgery)
- Difference in Self-reported Hearing Outcome With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study(3 or 6 months post-surgery, 12 and 24 months post-surgery)
- Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No.(24 months post-surgery)
- Battery Lifetime of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study(3 or 6 months post-surgery, 12 and 24 months post-surgery)
- Wearing Comfort of the Osia 2 Sound Processor at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study(3 or 6 months post-surgery, 12 and 24 months post-surgery)