Trials / Completed
CompletedNCT04310202
Multi-Centre Study on the Performance of the Ponto BHX Implant System (in Adult Patients)
A Prospective Multi-Centre Study on the Performance of the Ponto BHX Implant System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (actual)
- Sponsor
- Oticon Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. A total of 50 patients will be included in the study. The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Biohelix (BHX) Implant system.
Detailed description
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. A total of 50 patients will be included in the study. The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto BHX Implant system. The implant, coupled to a skin-penetrating abutment, is implanted in the bone behind the ear and is later loaded with a sound processor which transforms sound waves to sound vibrations that can be sent directly to the inner ear via the skull bone. The primary objective of this study is to investigate the proportion of implant/abutment complexes providing a reliable anchorage for a sound processor, 3 months after implantation/surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Abbreviated Profile of Hearing Aid Benefit (APHAB) | An intervention in this study which is outside the routine clinical practice of the clinics is the APHAB questionnaire that will be completed by the subjects on two occasions. |
| OTHER | Glasgow Benefit Inventory (GBI) | An intervention in this study which is outside the routine clinical practice of the clinics is the GBI questionnaire that will be completed by the subjects on two occasions. |
| OTHER | Additional follow-up visits after surgery | There are 1-2 additional follow-up visits after surgery (compared to the routine clinical practice of the surgeons/clinics). |
Timeline
- Start date
- 2021-01-17
- Primary completion
- 2023-04-24
- Completion
- 2023-12-20
- First posted
- 2020-03-17
- Last updated
- 2024-08-29
Locations
6 sites across 3 countries: Denmark, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT04310202. Inclusion in this directory is not an endorsement.