Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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) Exclusion Criteria: * No exclusion criteria have been set for this observational investigation
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)
- Northern California Veterans Affairs Healthcare SystemSacramento, California
- Clinical Hospital from the Ribeirão Preto Medical SchoolSão Paulo, São Paulo
- Queen Elizabeth II Health Sciences CentreHalifax, Nova Scotia
- Hospital Virgen de las NievesGranada, Andalusia
- Sunderby SjukhusLuleå, Norrbotten County
- Skåne University HospitalLund, Skåne County