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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
32
Healing cap II is used instead of the traditional healing cap as part of the surgical dressing after bone anchored hearing aid implant surgery
Dept. of Otolaryngology - Head & Neck Surgery and Audiology, Gentofte/Rigshospitalet
Gentofte Municipality, Hellerup, Denmark
Department of Oto-Rhino-Laryngology & Audiology, Aalborg University Hospital
Aalborg, Denmark
Skin reactions according to Holgers
Focus is on healing, post-operative complications and skin reactions after the first 7-14 days after surgery.
Time frame: At time of sugical follow up visit (visit window of 7-14 days after surgery)
Fitting of sound processor at surgical follow-up visit
Implant stability is monitored before and after sound processor fitting through ISQ and clinical assessments.
Time frame: At time of surgical follow up visit (visit window of 7-14 days after surgery)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.