Conductive Hearing Loss, Mixed Hearing Loss, Unilateral Partial Deafness
Conditions
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.
Interventions
Sponsors
Oticon Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of colony forming units (CFU) | 3 months post-surgery | The primary end point is CFU counts 3 months post-surgery. |
Secondary
| Measure | Time frame |
|---|---|
| Number of colony forming units (CFU), strip (CFU/strip) | 3 months post-surgery |
| Number of colony forming units (CFU) in tissue samples (CFU/mg | 3 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 |
| Histology investigation of tissue biopsy | 3 months post-surgery |
| Number of colony forming units (CFU) on abutment (CFU/abutment) | 3 months post-surgery |
Other
| Measure | Time frame |
|---|---|
| Skin status according to Holgers and clinical assessment | 3 months post surgery |
| Postoperative complications | 3 months post surgery |
| Pain and numbness | Up to 24 months post surgery |
| Implant stability by clinical assessment and implant stability quotient (ISQ)measurements | Up to 24 months post surgery |
| Pocket depth | 6 months post surgery |
Countries
Sweden
Outcome results
None listed