At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Soft Tissue Healing and Implant Stability of Cochlear Baha BI300/BA400 Implant System Loaded From 1 Week Post-surgery After Linear Incision Without Soft Tissue Reduction.
In Brief
A clinical study evaluating One week loading of Bone Anchored Hearing Aid (BAHA) and Cochlear Baha BI300/BA400 Implant System for Hearing Loss - Conductive. Completed, enrolled 25 participants across 1 site.
Detailed Summary
Objectives * To evaluate the safety of processor loading of the Cochlear BI300/BA400 implant system 1 week after implantation * To evaluate the short term soft tissue healing and the long term skin reaction, with the new Cochlear BI300/BA400 implant system using the linear incision without subcutaneous tissue reduction. * To produce reference data regarding the stability of the BI300/BA400 implant system. Study design: Prospective cohort study. Patients: 24 adults with anticipated normal skin and bone quality eligible for bone anchored implant surgery. Intervention: Loading of the sound processor one week after surgery Main outcome measures: Implant stability, soft tissue reaction, skin overgrowth, pain and numbness will be assessed. It is hypothesized that implant loading can be performed one week after surgery without any changes in implant stability, soft tissue reaction, skin overgrowth, pain or numbness around implant.
Study Details
Timeline
Interventions
Patients in this arm will be fitted with the BAHA one week after surgery.