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Recruiting NCT06930781

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

Conditions: Hearing Loss, Bone Anchored Hearing Aids

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Enrollment: 270

Sponsor: Oticon Medical

Location: Northern California Veterans Affairs Healthcare System Sacramento California

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 Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06930781). StuddyBuddy aggregates publicly available trial information.