RecruitingNCT06930781

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

Sponsor

Oticon Medical

Enrollment

270 participants

Start Date

May 7, 2025

Study Type

OBSERVATIONAL

Conditions

Hearing Loss Bone Anchored Hearing Aids

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Ponto implantation for people with bone anchored hearing aids and hearing loss. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPonto 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.