Ignite Creation Date:
2024-05-06 @ 2:18 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04279236
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2020-02-17
Brief Title:
Multi-Center Study on Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery in Adult Patients
Sponsor:
Oticon Medical
Organization:
Oticon Medical
Study Overview
Official Title:
A Prospective Multi-Center Study on the Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery MIPS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 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BAHS will be included in the study The total number of participants included in the study will be 64 Patients who are withdrawn from the study prior to completion will not be replaced
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 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 implantabutment complexes providing a reliable anchorage for a sound processor 3 months after implantationsurgery
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 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 implantabutment complexes providing a reliable anchorage for a sound processor 3 months after implantationsurgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None