OBJECTIVE: To describe the early surgical and audiometric outcomes in pediatric patients implanted with a new active transcutaneous bone conduction implant system. STUDY DESIGN: Retrospective case review. SETTING: Tertiary pediatric hospital. PATIENTS: Pediatric patients (18 or younger) with conductive or mixed hearing loss that completed postoperative aided testing following implantation with the Cochlear Osia system from December 2019 to December 2020. INTERVENTION: Rehabilitative. MAIN OUTCOME MEASURE: Preoperative air conduction (AC), preoperative bone conduction (BC), and postoperative aided thresholds were compared. Pure-tone averages (PTA), air-bone gap (ABG), and functional gain were calculated. Surgical complications and patient satisfaction were summarized from the chart review. RESULTS: Sixteen patients (20 implants) met the inclusion criteria. The average age at the time of implantation was 12.9 ± 2.4 years. The preoperative AC and BC thresholds were 64.4 dB (±11.9 dB) and 7.9 dB (±4.90 dB), respectively, with an average ABG of 56.5 dB (±12.8 dB). The average postoperative aided threshold was 21.2 dB (± 4.25 dB) with a mean functional gain of 43.1 dB (±10.2 dB). One patient developed seroma postoperatively, which was treated conservatively. No other complications were reported over a mean follow-up time of 7.1 ± 4 months. For 13 patients with previous passive bone conduction implants or devices, the Osia system was universally favored. CONCLUSIONS: The new active transcutaneous bone conduction system showed favorable early clinical and audiometric outcomes. Repeated processor connectivity issues represent a potential area for future device development. This is the largest pediatric case series to date.Level of Evidence: Level 4-Retrospective Review.
OBJECTIVE: To describe the early surgical and audiometric outcomes in pediatric patients implanted with a new active transcutaneous bone conduction implant system. STUDY DESIGN: Retrospective case review. SETTING: Tertiary pediatric hospital. PATIENTS: Pediatric patients (18 or younger) with conductive or mixed hearing loss that completed postoperative aided testing following implantation with the Cochlear Osia system from December 2019 to December 2020. INTERVENTION: Rehabilitative. MAIN OUTCOME MEASURE: Preoperative air conduction (AC), preoperative bone conduction (BC), and postoperative aided thresholds were compared. Pure-tone averages (PTA), air-bone gap (ABG), and functional gain were calculated. Surgical complications and patient satisfaction were summarized from the chart review. RESULTS: Sixteen patients (20 implants) met the inclusion criteria. The average age at the time of implantation was 12.9 ± 2.4 years. The preoperative AC and BC thresholds were 64.4 dB (±11.9 dB) and 7.9 dB (±4.90 dB), respectively, with an average ABG of 56.5 dB (±12.8 dB). The average postoperative aided threshold was 21.2 dB (± 4.25 dB) with a mean functional gain of 43.1 dB (±10.2 dB). One patient developed seroma postoperatively, which was treated conservatively. No other complications were reported over a mean follow-up time of 7.1 ± 4 months. For 13 patients with previous passive bone conduction implants or devices, the Osia system was universally favored. CONCLUSIONS: The new active transcutaneous bone conduction system showed favorable early clinical and audiometric outcomes. Repeated processor connectivity issues represent a potential area for future device development. This is the largest pediatric case series to date.Level of Evidence: Level 4-Retrospective Review.