NCT02274129

Clinical Survey of Oticon Medical Healing Cap

C51 - Clinical Survey of Oticon Medical Healing Cap

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Oticon Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Conductive Hearing Loss
• Mixed Hearing Loss
• Unilateral Partial Deafness

Interventions

Type	Name	Description
DEVICE	Healing cap II	Healing cap II is used instead of the traditional healing cap as part of the surgical dressing after bone anchored hearing aid implant surgery

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-10-01
• Completion: 2016-04-19
• First posted: 2014-10-24
• Last updated: 2017-11-27

Locations

2 sites across 1 country: Denmark