First Generation Osseointegrated Steady State Implant Benefits in Children With Hearing Loss.

ABSTRACT

OBJECTIVE: To assess outcomes of a new Osseointegrated Steady State Implant (OSSI) for bone conduction in adolescents. METHOD: In an initial trial, 14 adolescents (14.5 years of age, SD = 2.22) were provided with an OSSI; unilateral OSSI (n = 13), bilateral OSSI in sequential surgeries (n = 1). Outcomes measured were surgical duration, complications, hearing thresholds, speech perception and self-reported hearing benefits using the Speech and Spatial Quality of Hearing Questionnaire. RESULTS: The surgical times were mean 93.6 minutes (SD = 33.3). Surgery was slightly longer in three adolescents who required skin flap reduction (n = 1) or significant bone polishing (n = 2) (121.33 minutes, SD = 8.14). Adverse events occurred in two adolescents post-implant poor external device retention in one child requiring revision flap reduction and inflammation at the incision site due to magnet overuse in another. The "Digital Link Calibration" measure was a good proxy predictor of the strength of magnet required for external device adherence (p = 0.002). The OSSI increased audibility in the implanted ear by mean 31.48 dB HL (SE = 1.58). Aided thresholds were best at 1 kHz (mean 25.33 dB HL, SD = 22.60) and only slightly poorer at 3000 and 4000 Hz (estimate decrease = 8.33 dB HL, SE = 3.54), reflecting good auditory sensitivity even at high frequencies. Speech perception when using the new device alone was good (89.67%, SD = 7.84%) and self-reported hearing by participants and parents improved in all domains assessed by the Speech and Spatial Quality of Hearing Questionnaire (estimate = 1.90 points, SE = 0.25, p < 0.0001). CONCLUSION: The OSSI provides hearing benefits with surgical safety in a carefully selected cohort of adolescents.