Surgical Approaches and Complications in OSIA: a Systematic Review.

Area of Science:

• Otolaryngology
• Biomedical Engineering
• Surgical Innovation

Background:

• The Osseointegrated Steady-State Implant (OSIA) is an active transcutaneous bone conduction hearing system.
• It utilizes a piezoelectric actuator and osseointegrated anchor for hearing rehabilitation while preserving skin integrity.
• Existing literature on OSIA surgical approaches and complications is fragmented.

Purpose of the Study:

• To systematically review intraoperative and postoperative complications of OSIA implantation.
• To analyze the impact of incision orientation, patient age, and prior surgical history on complication rates.
• This is the first systematic review focusing on OSIA complications.

Main Methods:

• Systematic review registered with PROSPERO, adhering to PRISMA guidelines.
• Searched PubMed, Embase, and CENTRAL databases for studies from January 2016 to April 2025.
• Included 15 studies with 784 OSIA implants (prospective and retrospective cohorts).

Main Results:

• Low pooled intraoperative (0.77%) and postoperative (5.25%) complication rates.
• Incisions across the device (14.4%) had higher complication rates than incisions around the device (4.6%).
• Pediatric cohorts (10.2%) and patients with prior mastoidectomy (12.0%) showed higher complication rates than adult cohorts (4.3%).

Conclusions:

• OSIA implantation is generally safe for hearing rehabilitation.
• Surgical planning should consider incision orientation and patient-specific factors.
• Evidence-based risk stratification and preoperative counseling are supported by these findings.