Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population
NCT ID: NCT03723161
Last Updated: 2024-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
15 participants
OBSERVATIONAL
2018-09-04
2024-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Treatment
Bone Anchored Hearing surgery using a BHX implant manufactured by Oticon Medical
Bone Achored Hearing surgery
This is a observational study of pediatric patients undergoing bone anchored hearing surgery. The collected data will be used to assess the implant stability development of the Ponto BHX implant during up tp 24 months after implantation in a pediatric population undergoing bone anchored hearing surgery.
Interventions
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Bone Achored Hearing surgery
This is a observational study of pediatric patients undergoing bone anchored hearing surgery. The collected data will be used to assess the implant stability development of the Ponto BHX implant during up tp 24 months after implantation in a pediatric population undergoing bone anchored hearing surgery.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with atresia
* Signed informed consent
* Patients between 2,5 - 18 years of age
* Patients eligible for one stage surgery
Exclusion Criteria
* Unwillingness to participate in follow up visits
30 Months
18 Years
ALL
No
Sponsors
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Karolinska University Hospital
OTHER
Oticon Medical
INDUSTRY
Responsible Party
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Locations
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Karolinska University Hospital
Stockholm, , Sweden
Countries
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Other Identifiers
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C64
Identifier Type: -
Identifier Source: org_study_id
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