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

Launched by OTICON MEDICAL · Apr 8, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and outcomes of a procedure called Ponto implantation, which helps people with hearing loss. The study focuses on procedures done outside of the main operating room, in more everyday settings, to see how often complications happen when the surgery is performed this way. Researchers want to gather information from both past and current patients to get a better understanding of these procedures.

To be eligible for this study, participants must be adults aged 18 and older who have had a Ponto implant placed in an out-of-OR setting since 2019. There are no specific health conditions that would exclude someone from participating, and if you choose to join, you'll be asked to provide consent and may answer some questionnaires about your experience. Overall, this trial aims to improve the care and safety of patients receiving bone-anchored hearing aids in more accessible locations.

Gender

ALL

Eligibility criteria

• 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