At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Clinical Performance of Ponto Implantation Using a Minimally Invasive Surgical Technique - a Prospective Multicentre Study
In Brief
A clinical study evaluating Minimally invasive surgery, Glasgow Benefit Inventory (GBI), and 1 other intervention for Hearing Loss. Completed, enrolled 52 participants across 7 sites in 4 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
The subjects will be implanted with a bone anchored hearing system using a minimally invasive surgery.
A quality of life-questionnaire is to be completed by the subjects at one occasion.
There are 1-3 additional follow-up visits after surgery (compared to the routine clinical practice of the surgeons/clinics).