Clinical Survey of Different Abutment Topologies

Study Overview
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Brief Summary
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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.

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

Conditions
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Mixed Hearing Loss, Conductive Hearing Loss, Unilateral Partial Deafness

Intervention / Treatment
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* Device: Bone anchored hearing aid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Oticon Medical Machined Abutment<br>A non surface modified abutment is used | Device: Bone anchored hearing aid<br> <br> * Other names: BAHA;|
| Experimental: Oticon Medical Modified Abutment<br>A surface modified abutment is used | Device: Bone anchored hearing aid<br> <br> * Other names: BAHA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of colony forming units (CFU) | The primary end point is CFU counts 3 months post-surgery. | 3 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of colony forming units (CFU) on abutment (CFU/abutment) |  | 3 months post-surgery | 
| Number of colony forming units (CFU) on abutment (CFU/abutment) |  | 12 months post-surgery | 
| Number of colony forming units (CFU), strip (CFU/strip) |  | 3 months post-surgery | 
| Number of colony forming units (CFU), strip (CFU/strip) |  | 12 months post-surgery | 
| Number of colony forming units (CFU) in tissue samples (CFU/mg |  | 3 months post-surgery | 
| Number of colony forming units (CFU) in tissue samples (CFU/mg |  | 12 months post-surgery | 
| RNA level for host inflammatory response |  | 3 months post-surgery | 
| RNA level for tissue repair |  | 3 months post-surgery | 
| RNA level for host host microbial infection response |  | 3 months post-surgery | 
| RNA level for host inflammatory response |  | 12 months post-surgery | 
| RNA level for tissue repair |  | 12 months post-surgery | 
| RNA level for host host microbial infection response |  | 12 months post-surgery | 
| Histology investigation of tissue biopsy |  | 3 months post-surgery | 
| Histology investigation of tissue biopsy |  | 12 months post-surgery |