The new Baha implant: a prospective osseointegration study.

OBJECTIVES: To assess stability of a new-design titanium implant (Cochlear Baha BAI300) in bone-anchored hearing aid (Baha) recipients over time.

STUDY DESIGN AND SETTING: Prospective case series with planned data collection at a tertiary care institution. Twelve patients who underwent Baha surgery over 12 months were analyzed.

SUBJECTS: All patients (3 children, age range 6-10 years, mean 7.7 years, median 7.3 years; 9 adults, age range 34-73 years, mean 52.8 years, median 48 years) underwent the 1-stage procedure following the standard Brånemark technique. In all procedures, the single-skin incision was applied.

METHODS: The stability of the implant was measured with implant stability quotient (ISQ) measurement tests. All patients were tested at surgery and every week after for 1 year. Wound-healing time, degree of soft tissue reactions around the abutment, and need for revision surgery were examined. Two-tailed Student t test and χ(2) for all comparisons were calculated; P < .05 values were considered significant.

RESULTS: The new implant showed a steep increase of ISQ values over the first 2 weeks and reached stable ISQ values 3 weeks after surgery. Complete skin healing time was obtained in 8 days on average (range, 7-12 days; median 7.6 days). Neither implant extrusion nor skin revision surgery was observed in our patients during the first year of follow-up.

CONCLUSIONS: This new implant revealed stability and fast integration. The data from the present study suggest the new implant may be suitable for early loading protocols.