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

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

This study is a combined retro- and prospective, single arm, multicentre investigation designed to follow clinical practice for Ponto-implantations performed out of OR. The overall objective is to investigate the complication rate for procedures performed 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.

Inclusion Criteria:

• Adult subjects (≥18 years old) undergoing Ponto implantation in an out-of-OR setting from 2019 and onwards
• Signed informed consent (applicable for subjects answering questionnaires)

Exclusion Criteria:

• No exclusion criteria have been set for this observational investigation