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
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
Inclusion Criteria2
- 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)
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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.
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT06930781
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