Study of Outcomes and Safety for Ponto Implant Surgeries Performed Outside the Main Operating Room

What this Trial Is About

This research aims to follow clinical practice for Ponto-implantation surgeries performed outside the main operating room out-of-OR to investigate the complication rates associated with these procedures. It is a combined retrospective and prospective observational study conducted at multiple centers, focusing on patients with hearing loss who receive bone-anchored hearing aids. The study includes patients who had the procedure from 2019 onward and those planned for surgery in the future. The study observes Ponto implantation, a surgical procedure that implants a bone-anchored hearing device to improve hearing by transmitting sound through bone conduction directly to the inner ear. The retrospective part reviews charts of past patients treated out-of-OR since 2019. The prospective part includes patients undergoing planned out-of-OR Ponto implantation who also complete three questionnaires after surgery and during follow-up, including after the sound processor is loaded. Participants contribute data through retrospective chart reviews or by completing questionnaires about their surgical and hearing experiences. The study measures intraoperative complications during surgery and assesses procedure room factors, surgical parameters, post-operative events, implant survival rates, time to sound processor loading, device usage time, and hearing rehabilitation effectiveness. Follow-up extends on average about one year after surgery to monitor outcomes and patient-reported benefits.

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