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.
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Number and Type of Reported Adverse Events
Timeframe: 6 months post-surgery to 24 months post-surgery
Number and Type of Reported Device Deficiencies
Timeframe: 6 months post-surgery to 24 months post-surgery
Concomitant Medication Used
Timeframe: 6 months post-surgery to 24 months post-surgery
Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
Timeframe: 12 months post-surgery
Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
Timeframe: 24 months post-surgery
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
Timeframe: Baseline before surgery, 12 months and 24 months post-surgery