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

Launched by OTICON MEDICAL · Mar 12, 2020

Keywords

ClinConnect 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 BHX Implant system. The implant, coupled to a skin-penetrating abutment, is implanted in the bone behind the ear and is later loade...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years of age or older
• • Patients indicated for surgical intervention with a bone anchored hearing system according to local clinic's standard guidelines
• • Adequate bone quality to allow for a Ponto BHX implant insertion, as judged by the investigator, and an expected bone thickness above 3 mm, where no complications during surgery are expected
• Exclusion Criteria:
• • Patients undergoing re-implantation
• • Patients who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales.
• • Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus
• • Known conditions (e.g. uncontrolled diabetes) that could jeopardize skin condition and wound healing over time as judged by the investigator
• • Any other known condition that the investigator determines could interfere with compliance or study assessments