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Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)
Sponsor: Oticon Medical
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
270
Start Date
2025-05-07
Completion Date
2027-04-01
Last Updated
2026-07-08
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (6)
Northern California Veterans Affairs Healthcare System
Sacramento, California, United States
Clinical Hospital from the Ribeirão Preto Medical School
São Paulo, São Paulo, Brazil
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Hospital Virgen de las Nieves
Granada, Andalusia, Spain
Sunderby Sjukhus
Luleå, Norrbotten County, Sweden
Skåne University Hospital
Lund, Skåne County, Sweden