Conductive Hearing Loss Clinical Trial
Official title:
Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation
A bone anchored hearing system is used to improve hearing for patients with e.g.
conductive/mixed hearing loss or single sided deafness.
With this type of system, a titanium implant is installed in the temporal bone, where it
osseointegrates, i.e. integrates with the bone. An abutment (also in titanium) is attached to
the implants and penetrates the skin. The sound processor (hearing aid) is then connected to
the abutment, and can be attached and removed by the patient via a snap-coupling. This type
of system has been successfully implanted in more than 100.000 patients. Recently, a
simplified surgical procedure, where no skin thinning around the abutment is made, was
approved. The results after using this installation technique, here called soft tissue
preservation, are the focus of this study.
The objective of the study is to compare the outcomes after a surgical procedure with soft
tissue preservation (test) and a surgery with soft tissue reduction (control) for placing
Oticon Medical Ponto implants and abutments. The main hypothesis is that patient numbness
around the implant is less in the test group compared to the control group.
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