Multi-Centre Study on the Performance of the Ponto BHX Implant System (in

Status Active, not recruiting

Clinical Trial Summary

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Hearing Loss

Clinical Trial Details

NCT number	NCT04310202
Study type	Observational
Source	Oticon Medical
Contact
Status	Active, not recruiting
Phase
Start date	January 17, 2021
Completion date	January 31, 2024

View Details

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Multi-Centre Study on the Performance of the Ponto BHX Implant System (in Adult Patients)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms