Outcome of the bone-anchored hearing aid procedure without skin thinning: a prospective clinical trial.

OBJECTIVE: To evaluate the outcome of Bone-Anchored Hearing Aid surgery without skin thinning, a test group with direct implantation without such thinning was compared with a control group that underwent the traditional procedure.

STUDY DESIGN: This was a single-center, prospective clinical trial designed to evaluate a novel approach to Bone-Anchored Hearing Aid implantation. Eligible patients were enrolled consecutively in the test group or selected to be age-matched controls.

SETTING: University Hospital.

PATIENTS: Eighteen adult patients, suffering from hearing loss, suitable for implantable hearing aid.

METHODS: Single-step surgery was performed on 18 patients under local anesthesia. In 9 of these, a linear incision was made, a hole was punched through the skin above the bone-anchored implant, and a longer abutment (8.5-12 mm) was introduced, whereas the other 9 were subjected to the standard protocol, using a dermatome and skin thinning. All of the patients were followed for 12 months.

RESULTS: The test group exhibited good preservation of the tissue, no increasing skin reactions and no adverse events. The time required for this surgery was reduced, as was their healing time. These patients also experienced less numbness and pain in the surrounding area and had an improved cosmetic outcome. MAIN OUTCOME AND CONCLUSION: This clinical trial indicates that introduction of the abutment to the osseointegrated screw directly through the skin, without skin thinning, could be beneficial. This approach had fewer negative effects than the conventional procedure during the 12- month follow-up period.