MED-EL Bonebridge implantation in pediatric patients age 11 Years and younger: Is it safe and effective?

Abstract

Objective: To present our experience with off-label MED-EL Bonebridge implantation in pediatric patients younger than 12 years of age and compare outcomes to pediatric patients 12 years and older.

Methods: Pediatric patients who underwent Bonebridge implantation were included in a retrospective cohort study and were categorized by off-label use (<12 years) and ≥12 years at time of bone conduction implantation (BCI). Hearing outcomes were collected after implant activation, which was typically 4-8 weeks post-implantation. Mann-Whitney U tests were performed to assess for differences between audiometric outcomes. Significance was set at p < 0.05.

Results: Twenty patients (25 implants) < 12 years of age and 17 patients (23 implants) ≥12 years of age underwent BCI. Pre-BCI speech recognition threshold (SRT) was better for the older patient group (median 50 dB) than the younger patient group (median 60 dB). Post-BCI SRT, however, was significantly lower in the younger patient group (median 22.5 dB) as compared to the older patient group (median 35 dB), (p < 0.001, Z = 3.1). The two groups performed similarly on age-appropriate wordlists presented at 50 dB HL in aided conditions (p > 0.05, -1

Conclusion: Pediatric patients younger than 12 years showed similar or better audiometric benefit from off-label Bonebridge implantation when compared to older patients. Pediatric patients younger than 12 years can be considered Bonebridge implant candidates if clinically indicated; Bonebridge implantation in this age group appears safe and technically feasible.