Ponto Implantation Using a Minimally Invasive Surgical Technique

Status Completed

Clinical Trial Summary

Clinical Trial Description

This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Sweden, Denmark and the Netherlands). In total, 50 adult patients with a hearing loss that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. The purpose of the study is to investigate the rate of successful BAHS use after implantation of the Ponto implant system using a minimally invasive surgical technique. 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 three months after implantation/surgery. ;

Study Design

Related Conditions & MeSH terms

Hearing Loss

Clinical Trial Details

NCT number	NCT04606823
Study type	Interventional
Source	Oticon Medical
Contact
Status	Completed
Phase	N/A
Start date	November 4, 2020
Completion date	April 26, 2023

View Details

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