Clinical Study of Minimally Invasive Ponto Surgical Technique (MIPS) - Design Iteration

Clinical Study of Minimally Invasive Ponto Surgical Technique (MIPS) - Design Iteration

The objective of the study is to compare the outcomes after a surgical procedure with minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control) for placing Oticon Medical Ponto implants and abutments.

Inclusion Criteria:

• 18 years or older.
• Patient indicated for an ear level bone anchored sound processor.
• Healthy bone quality to allow for 4mm implant insertion.

Exclusion Criteria:

• Intraoperative switch to an alternative surgical technique
• Patients undergoing re-implantation (on the side being included in the study)
• Previous participation in the C47 study.
• Inability to participate in follow-up.
• Psychiatric disease in the medical history.
• Mental disability.
• Presumed doubt, for any reason, that the patient will be able to show up on all follow-ups.
• Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
• Patients with natural skin height of >12mm (as there will be additional skin reduction needed)