Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)

The study is observational and non interventional and follows clinical practice at participating clinics with the only exception of three questionnaires given to consenting patients after surgery and during follow-up, after loading of the sound processor.

The study is a combined retro- and prospective study. The retrospective part consists of a chart review of patients who have undergone Ponto-implantation out of OR from 2019 and onwards. The prospectively recruited subjects are patients who are planned to undergo Ponto-implantation surgery out-of-OR.

• Assessment of procedure room variables [Срок оценки: 12 months after study start]
• To assess surgical parameters [Срок оценки: During Ponto-implantation surgery]
• Evaluation of patient experience of surgical procedure based on Ponto procedure questionnaire [Срок оценки: 5-10 days after Ponto surgery]
• To assess postoperative events and complications [Срок оценки: From day of surgery, through study completion, an average of 1 year]
• To assess rate of implant survival [Срок оценки: 3 months after surgery, and through study completion, an average of 1 year.]
• To assess time from surgery to sound processor loading [Срок оценки: Time from surgery to sound processor loading which happens at an average of 3 months after surgery.]
• To assess sound processor usage time [Срок оценки: 3 months after surgery, and through study completion, an average of 1 year.]
• To assess effectiveness of hearing rehabilitation using IOI-HA questionnaire [Срок оценки: 3 months after surgery]
• To assess patient-reported benefit after BAHS treatment using the questionnaire Glasgow Benefit Inventory (GBI) [Срок оценки: 3 months after surgery]