deafness hearing loss
Conditions
Interventions
The surgical placement (conventional versus the simplified surgical technique)
of the comparator (Baha BA300) or investigational device (Baha BA400)
Sponsors
COCHLEAR BONE ANCHORED SOLUTIONS AB
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Adult patient, i.e. * 18 years of age * Eligible for the Baha system * Signed informed consent
Exclusion criteria
Exclusion criteria: * Patient scheduled for simultaneously bilateral implant surgery * Uncontrolled diabetes as judged by the investigator * Condition that could jeopardize osseointegration and/or wound healing, e.g. osteoporosis, psoriasis and use of corticosteroids * Unable to follow the cleaning instruction * Unable to follow investigational procedures, e.g. to complete quality of life scales * Participation in another investigation with pharmaceuticals and/or device * Condition that may have an impact on the outcome of the investigation as judged by the investigator * Suitable implant position for the 4 mm implant not found during surgery due to insufficient bone quality and/or bone thickness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The first primary endpoint, a combined endpoint of infection/inflammation, overgrowth, pain and numbness,will be evaluated by a function of the Holgers Index, the Soft tissue thickening/over-growth scale, POSAS pain scale, question regarding pain in scar/neuropathic pain and Numbness scale. The second primary variable, the costs of the surgical procedure, complications and number of extra wound dressings sessions will be evaluated by surgical time, Holgers Index and the number of extra dressing sessions. The costs will be estimated and evaluated in local currency. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Wound healing * Numbness * Pain * Aesthetics * Complications * Overgrowth * Quality of Life | — |
Countries
Netherlands
Outcome results
None listed