NCT04606823

Ponto Implantation Using a Minimally Invasive Surgical Technique

Evaluation of Clinical Performance of Ponto Implantation Using a Minimally Invasive Surgical Technique - a Prospective Multicentre Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Oticon Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
PROCEDURE	Minimally invasive surgery	The subjects will be implanted with a bone anchored hearing system using a minimally invasive surgery.
OTHER	Glasgow Benefit Inventory (GBI)	A quality of life-questionnaire is to be completed by the subjects at one occasion.
OTHER	Additional follow-up visits after surgery	There are 1-3 additional follow-up visits after surgery (compared to the routine clinical practice of the surgeons/clinics).

Timeline

• Start date: 2020-11-04
• Primary completion: 2022-08-09
• Completion: 2023-04-26
• First posted: 2020-10-28
• Last updated: 2026-01-29
• Results posted: 2026-01-29

Locations

7 sites across 4 countries: Denmark, Netherlands, Sweden, United Kingdom