Trials / Completed
CompletedNCT03742089
Evaluation of the BHX Implant in Children with a BAHS
Evaluation of Implant Stability and Audiological Benefit of Oticon Medicals BHX Implant in Children Undergoing Surgery for a Percutaneous Bone Anchored Hearing System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 15 (actual)
- Sponsor
- Oticon Medical · Industry
- Sex
- All
- Age
- 5 Years – 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Bone Anchored Hearing Surgery | This is a observational study of pediatric patients undergoing bone anchored hearing surgery. The collected will be used to assess the implant stability development of the Ponto BHX implant during up to 24 months after implantation in a pediatric population undergoing BAHS. The study will also monitor the Ponto BHX implant safety and survival throughout the study period. |
Timeline
- Start date
- 2018-05-22
- Primary completion
- 2023-06-14
- Completion
- 2024-09-22
- First posted
- 2018-11-15
- Last updated
- 2024-10-31
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03742089. Inclusion in this directory is not an endorsement.