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


Primary Outcome

Number of colony forming units (CFU)

Secondary Outcome

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


Conductive Hearing Loss


Bone anchored hearing aid

Study Arms / Comparison Groups

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


* 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


Estimated Enrollment


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

        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




18 Years - N/A

Accepts Healthy Volunteers



Sofia Jonhede, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Oticon Medical

Study Sponsor

Sofia Jonhede, Study Chair, Sponsor GmbH

Verification Date

February 2018