Surgical Approaches and Complications in OSIA: a Systematic Review

The Osseointegrated Steady-State Implant (OSIA) is an active transcutaneous bone conduction system offering effective hearing rehabilitation via a piezoelectric actuator and osseointegrated anchor, while preserving skin integrity. Despite the growing adoption of OSIA, the literature on optimal surgical approaches and complication patterns remains fragmented.

This is the first systematic review aimed at evaluating intraoperative and postoperative complications associated with OSIA implantation, with a specific focus on incision orientation, patient age, and prior surgical history.

A systematic review was registered with PROSPERO and conducted per PRISMA guidelines. PubMed, Embase, and CENTRAL were searched for studies published from January 2016 to April 2025. Fifteen eligible studies were included, encompassing 784 OSIA implants across prospective and retrospective cohorts.

OSIA implantation was associated with a low pooled intraoperative complication rate of 0.77% and a postoperative complication rate of 5.25%. Most complications were mild and manageable, with no cases requiring permanent device removal. Incisions placed across the device had a significantly higher complication rate (14.4%) compared to incisions placed around the device (4.6%). Pediatric-predominant cohorts experienced more complications (10.2%) than adult-predominant cohorts (4.3%). Patients with prior mastoidectomy had a complication rate of 12.0%.

OSIA is a generally safe hearing solution, but surgical planning should consider patient-specific factors and incision orientation. Incisions placed across the device are linked to higher complication rates. These findings support evidence-based risk stratification and preoperative counseling.