A Prospective Multi-Center Study on the Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery (MIPS)
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- STATUS
- Recruiting
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- End date
- Sep 30, 2023
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- participants needed
- 64
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- sponsor
- Oticon Medical
Summary
This prospective, multi-center study funded by Oticon Medical AB will be conducted at six clinical sites in North America. 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. The total number of participants included in the study will be 64.
The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Implant system using the surgical technique Minimally Invasive Ponto Surgery (MIPS).
Description
This prospective, multi-centre study funded by Oticon Medical AB will be conducted at six clinical sites in North America. 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. The total number of participants included in the study will be 64. Patients who are withdrawn from the study prior to completion will not be replaced.
The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Implant system using the surgical technique Minimally Invasive Ponto Surgery (MIPS). 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.
Details
| Condition | Hearing Loss |
|---|---|
| Treatment | Abbreviated Profile Hearing Aid Benefit (APHAB), Glasgow Benefit Inventory (GBI), Additional follow-up visit |
| Clinical Study Identifier | NCT04279236 |
| Sponsor | Oticon Medical |
| Last Modified on | 24 October 2022 |
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