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.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hearing Loss
- Sponsor
- Cochlear
- Enrollment
- 20
- Locations
- 3
- Primary Endpoint
- Concomitant Medication Used
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject has performed Hearing assessment at 3 and/or 6 months in the clinical investigation CBAS5751
- •Willing and able to provide written informed consent
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Concomitant Medication Used
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Secondary Outcomes
- 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)