Multi-Centre Study on Performance of the Ponto BHX Implant System - v1
Research type
Research Study
Full title
A Prospective Multi-Centre Study on the Performance of the Ponto BHX Implant System
IRAS ID
277035
Contact name
Rupan Banga
Contact email
Sponsor organisation
Oticon Medical AB
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
This prospective, multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). In the UK, the study will be performed at the Queen Elizabeth Hospital Birmingham and St Thomas’ Hospital in London. 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. Twenty-five patients will be included in the UK and the total number of patients in the study will be 50.
The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto BHX implant. 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 vibrations transmitted directly to the inner ear via the bone. The primary objective is to investigate the proportion of implant/abutment complexes providing a reliable anchorage for the sound processor, 3 months after surgery. For a positive outcome of the primary endpoint (reliable anchorage), the implant should be in place and stable without any adverse skin reactions or skin over-growth and pain preventing usage of the sound processor.
The study includes seven visits; one before surgery, surgery visit, and five follow-up visits (last visit 12 months after surgery). At the follow-up visits, the implant stability will be assessed, the skin around the implant will be examined and the patient will be asked about pain around the implant. In addition, complications and adverse events will be collected. Subjective evaluation of quality of life will be performed via two validated questionnaires (APHAB and GBI). This is a post-market study and all products used are CE-marked and used in clinical practice worldwide.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
20/NW/0226
Date of REC Opinion
18 Jun 2020
REC opinion
Further Information Favourable Opinion