Clinical Trial: Clinical Survey of Oticon Medical Healing Cap

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: C51 - Clinical Survey of Oticon Medical Healing Cap

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 Summary: 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.
Sponsor: Oticon Medical

Current Primary Outcome: Skin reactions according to Holgers [ Time Frame: At time of sugical follow up visit (visit window of 7-14 days after surgery) ]

Focus is on healing, post-operative complications and skin reactions after the first 7-14 days after surgery.


Original Primary Outcome: Same as current

Current Secondary Outcome: Fitting of sound processor at surgical follow-up visit [ Time Frame: At time of surgical follow up visit (visit window of 7-14 days after surgery) ]

Implant stability is monitored before and after sound processor fitting through ISQ and clinical assessments.


Original Secondary Outcome: Same as current

Information By: Oticon Medical

Dates:
Date Received: October 14, 2014
Date Started: July 2014
Date Completion:
Last Updated: April 7, 2017
Last Verified: April 2017