CompletedNot Applicable

Evaluation of the BHX Implant in Children with a BAHS

United Kingdom15 participantsStarted 2018-05-22

Plain-language summary

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

Who can participate

Age range5 Years – 16 Years

SexALL

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Inclusion criteria

✓. Patients who have decided to undergo a Bone Anchored Hearing Surgery and receive a Ponto system.
✓. Signed informed consent.
✓. Patients between 5 - 16 years of age.
✓. Patients eligible for one stage surgery.
✓. Patients who have been using Ponto sound processor on a soft band for at least 2 weeks.

Exclusion criteria

✕. Patients who cannot attend follow up visits.
✕. Patients with single side deafness (SSD).
✕. In surgeon's opinion, any other disorder and condition that may deem the patient unfit to participate in the study.
✕. Patients who receive other implant than the Ponto BHX.

What they're measuring

Implant stability

Timeframe: 6 months post surgery

Trial details

NCT IDNCT03742089

SponsorOticon Medical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-06-14

View on ClinicalTrials.gov More Hearing Loss, Conductive trials