Multi-Center Study on Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery (in Adult Patients)
Completed
Conditions studied: Hearing Loss
In brief
This prospective, multi-center study funded by Oticon Medical AB will be conducted at six clinical sites in North America. 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. The total number of participants included in the study will be 64. The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Implant system using the surgical technique Minimally Invasive Ponto Surgery (MIPS).
Key facts
- Study ID
- NCT04279236
- Run by
- Oticon Medical
- People needed
- 64
- Starts
- 2020-06-15
- Expected to finish
- 2024-12-10
- Last updated by the study team
- 2025-01-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years of age or older
- Patient indicated for surgical intervention with a bone anchored hearing system according to local clinic's standard guidelines.
- Normal bone quality and bone thickness above 3 mm, where no complications during surgery are expected.
- Skin thickness of 12mm or less at the implant site
You may not qualify if…
- 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.
Where it is running
- Silverstein Institute — Sarasota, Florida, United States
- Otolaryngology Associates — Indianapolis, Indiana, United States
- New York Eye and Ear Infirmary — New York, New York, United States
- Northwest Ear Institute — Portland, Oregon, United States
- UT Southwestern Medical Center — Dallas, Texas, United States
- Virginia Commonwealth University — Richmond, Virginia, United States
- The Research Institute of the McGill University Health Centre — Montreal, Quebec, Canada
- Hospital Universitario de Donostia — San Sebastián, Gipuzkoa, Spain
Full record on ClinicalTrials.gov
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