Ignite Creation Date:
2024-05-06 @ 3:22 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02274129
Status:
COMPLETED
Last Update Posted:
2017-11-27
First Post:
2014-10-14
Brief Title:
Clinical Survey of Oticon Medical Healing Cap
Sponsor:
Oticon Medical
Organization:
Oticon Medical
Study Overview
Official Title:
C51 - Clinical Survey of Oticon Medical Healing Cap
Status:
COMPLETED
Status Verified Date:
2017-11
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 study investigates the use of a new healing cap which through altered design and choice of material has been improved when it comes to minimizing the risk of it falling off as well as increasing patient comfort
Detailed Description:
This study will primarily investigate the use of a new healing cap Healing cap II The new healing cap has the same function as previous healing caps but it soft instead of hard Due to this the healing cap is anticipated to not fall off as easily but at the same time does not risk transferring larger forces than previously to the implant Secondly the patients will start using the sound processor 1-2 weeks after surgery The implant stability will be monitored before and after loading by the use of resonance frequency analysis an established method to evaluate and monitor osseointegrated implants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None