NCT06930781

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 270 (estimated)
• Sponsor: Oticon Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hearing Loss
• Bone Anchored Hearing Aids

Interventions

Type	Name	Description
DEVICE	Ponto implantation	Ponto implantation is a surgical procedure to implant a bone-anchored hearing device, improving hearing by transmitting sound directly to the inner ear through bone conduction.

Timeline

• Start date: 2025-05-07
• Primary completion: 2026-10-30
• Completion: 2026-12-01
• First posted: 2025-04-16
• Last updated: 2025-05-18

Locations

2 sites across 1 country: Sweden

Regulatory

• FDA-regulated device study