Pediatric Expansion Study of the Sentio System
Recruiting
N/A
Interventional Study
Hearing Loss, Conductive
Hearing Loss, Mixed
Single Sided Deafness
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 3 – 11
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- Oticon Medical · Industry
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About This Trial
This study is performed to collect safety and performance data supporting the use of the Sentio system in children below 12 years of age. The system is currently available on the market for patients 12 years and above. It is a prospective study conducted at eight European hospitals, aiming to treat 50 patients with a hearing loss than would benefit from treatment with a bone-anchored hearing syste…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Signed Informed Consent Form (depending on age of child, signed by parent or legal guardian and child)
2. Subject aged 3 to 11 years
3. Subject with:
3.1 conductive or mixed hearing losses with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 …
Contacts