Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)
Recruiting
Observational Study
Hearing Loss
Bone Anchored Hearing Aids
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 270 (estimated)
- Sponsor
- Oticon Medical · Industry
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About This Trial
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.
Trial Locations
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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 investigat…
Contacts