CompletedNot Applicable

Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population

Sweden15 participantsStarted 2018-09-04

Plain-language summary

The purpose of this study is to in a proactive manner collect high quality data from a pediatric patients who have undergone a bone anchored hearing solution, using the Ponto BHX implant, in clinical practice. This to further increase the knowledge of using the system.

Who can participate

Age range30 Months – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients who have decided to undergo a Bone Anchored Hearing Surgery * Diagnosed with atresia * Signed informed consent * Patients between 2,5 - 18 years of age * Patients eligible for one stage surgery Exclusion Criteria: * Not fluent in Swedish or English; subject and/or legal guardian * Unwillingness to participate in follow up visits

What they're measuring

Stability 12 months

Timeframe: 12 months post surgery

Trial details

NCT IDNCT03723161

SponsorOticon Medical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-01-10

View on ClinicalTrials.gov More Hearing Loss trials