Clinical Survey of Different Abutment Topologies

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Brief Title

Clinical Survey of Different Abutment Topologies

Official Title

C49:Clinical Survey of Different Abutment Topologies Installed With a Minimally Invasive Surgery for Bone Anchored Hearing Systems

Brief Summary

      This study is designed to compare two different surfaces of bone anchored hearing aid
      abutments in terms of bacterial colonization, inflammatory response and skin reactions.
    



Study Type

Interventional


Primary Outcome

Number of colony forming units (CFU)

Secondary Outcome

 Number of colony forming units (CFU) on abutment (CFU/abutment)

Condition

Conductive Hearing Loss

Intervention

Bone anchored hearing aid

Study Arms / Comparison Groups

 Oticon Medical Machined Abutment
Description:  A non surface modified abutment is used

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

14

Start Date

October 2014

Completion Date

December 2017

Primary Completion Date

March 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Any adult (18 years of age or older) patient eligible for a bone anchored hearing
             system

        Exclusion Criteria:

          -  Inability or unwillingness to participate in follow-up

          -  Skin thickness of > 10 mm

          -  Diseases known to compromise bone quality

          -  Irradiated in the implant area
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Sofia Jonhede, , 

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT02304692

Organization ID

C49


Responsible Party

Sponsor

Study Sponsor

Oticon Medical


Study Sponsor

Sofia Jonhede, Study Chair, Sponsor GmbH


Verification Date

February 2018