Author(s)
Samantha Goh
MBBS MA PGDip FRCS
Sharon L. Cushing, MD MSc FRCSC
Vicky Papaioannou, M.CI.Sc
Karen A. Gordon, PhD
Blake C. Papsin, MD FRCSC
Affiliation(s)
1 ) Department of Otolaryngology – Head and Neck Surgery, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.2 ) Department of Communication Disorders, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.3 ) Institute of Medical Science, University of Toronto, Toronto, ON, Canada4 ) Archie’s Cochlear Implant Laboratory, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.;
Abstract:
Introduction:
The osseointegrated steady-state implant (Osia®) system is an active transcutaneous bone-conduction device (BCD) that avoids soft tissue complications of percutaneous BCD in children. Early access to sound improves developmental outcomes, but current U.S. Food and Drug Administration (FDA) approval for Osia® is >12 years-of-age.
Objectives:
To report our experience of pediatric Osia®, comparing candidacy and outcomes between young children(<12y) and adolescents(>12y).
Methods:
A retrospective review of patients (<18y) receiving Osia® in our centre, from 2018-2023, was conducted. Surgical outcomes of patients >12y and <12y at time-of-implant were compared (primary outcome - adverse events(AE) requiring re-operation; difficulty proxy measure - operative time).
Results:
98 patients(age-range, mean(SD); 4-18y, 11(4)y) received unilateral (n=91) or bilateral (n=7) Osia®(N=106 OSIA® implants). Approximately half, 53%(56/106), were <12y (mean(SD)= 7(2)y) at the time of implantation and 47%(50/106) were >12y (mean(SD)= 15(1)y). Mean(SD) operative times were similar between groups (<12y, 71(24); >12y, 80(23)min). Most patients had prior experience with other BCD, 50% wore non-surgical BCD (<12y n=36; >12y n=17), 39% had a prior surgical BCD (<12y n=14; >12y n=27) and 11% did not use BCD.
Devices implanted in <12y (4.7%(5/106)) experienced fewer post-op complications compared to >12y (14.1%(15/106)). In <12y, there were no adverse events requiring re-operation, all complications resolved with conservative management (i.e., implant-site pain, irritation). In >12y, majority of implant-site complications were conservatively managed (9.4% (10/106)), however, one (0.9%) implant-site infection required intravenous antibiotics, and four (3.7%) were AE requiring re-operation (i.e., infected hematoma(n=2) leading to device-exposure and explantation; thick overlying skin surgically revised (n=2)). Of note, one patient had a particularly difficult recovery with AE: 1st device – infected hematoma (explanted); 2nd device (re-implantation) – subsequent skin revision.
Conclusions:
Osia® devices have been provided in our centre to children across a wide age-range with low morbidity rates, demonstrating their feasibility in both adolescents and young children.