10-year Follow-up of the Ponto Wide-implant

Launched by UNIVERSITY MEDICAL CENTER NIJMEGEN · Jan 9, 2025

Keywords

ClinConnect Summary

This is a single-center, prospective observational study in Nijmegen, Netherlands, following people who already had a Ponto Wide bone-anchored hearing implant implanted at least 10 years ago. Researchers want to learn whether the implant stays in place for 10 years (implant survival) and to explore secondary questions like how often implants or their connecting parts are lost or removed and why, how stable the implant is, skin problems around the implant, how many hours per day the sound processor is used, and overall quality of life after the implant. About 64 participants are planned, and they will be checked during routine clinic visits over the study period.

Eligible participants are children or adults of any sex who received a Ponto Wide implant (4.5 mm diameter, 4.0 mm length) at least 10 years ago and who previously took part in one of two Oticon Medical studies; they must consent to join. There are no specific extra health exclusions listed. Participating involves a clinic visit between November 2024 and March 2025, where clinicians will examine the skin around the implant, measure stability, and have the person complete two questionnaires about hearing-related quality of life. The study does not involve new drugs or treatments, and individual participant data will not be shared publicly.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Implantation with Ponto Wide implant (diameter 4.5 mm, length 4.0 mm)
• • Ten or more years of post-operative follow-up.
• • Valid informed consent
• Exclusion Criteria:
• • No specific exclusion criteria have been set for the study.