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Surgical Considerations for an Osseointegrated Steady State Implant (OSIA2®) in Children

INTRODUCTION Bone conduction devices provide access to sound in children who are otherwise unable to wear or gain benefit from conventional hearing aids. They are used to treat conductive and sensorineural hearing losses resulting from a variety of etiologies, such as aural atresia or single-sided deafness. The application of such devices has been limited in part by soft tissue complications, particularly those associated with skin-penetrating abutments. The osseointegrated steady state implant 2 (OSIA2) System was developed to provide hearing through bone conduction while avoiding complications previously reported in children using percutaneous devices. We aim to describe the candidacy and surgical technique developed for implantation of this device in a pediatric cohort. METHODS AND MATERIALS The study protocol was approved by the Research Ethics Board at the Hospital for Sick Children (REB# 1000073263) (REB#1000058120). All devices were purchased by our institution. The first five devices were inserted following case-by-case approval through Health Canada’s special access program. The remaining 38 devices were implanted after the OSIA2 was approved for clinical use. The described use of the OSIA2 in children under 12 is considered off-label from the perspective of the United States Food and Drug Administration.