Status:
COMPLETED
Multi-Center Study on Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery (in Adult Patients)
Lead Sponsor:
Oticon Medical
Conditions:
Hearing Loss
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Detailed Description
This prospective, multi-centre 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
June 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 10 2024
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04279236
Start Date
June 15 2020
End Date
December 10 2024
Last Update
January 27 2025
Active Locations (8)
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1
Silverstein Institute
Sarasota, Florida, United States, 34239
2
Otolaryngology Associates
Indianapolis, Indiana, United States, 46237
3
New York Eye and Ear Infirmary
New York, New York, United States, 10003
4
Northwest Ear Institute
Portland, Oregon, United States, 97210