Outcomes Following Cochlear Osia 2 Implantation in Patients Ages 5-11 Years: A Multi-Center Trial.

INTRODUCTION

The Osia 2 System is an active transcutaneous bone conduction hearing device. From 2022 to 2024, an FDA-approved, prospective, multi-center, open-label clinical trial was run through seven US-based centers. This trial sought to demonstrate the safety and efficacy of the Osia2 system in children aged 5-11 to expand indications.

METHODS

Fifty children aged 5-11 years (mean 7.4 years), presenting with conductive/mixed hearing loss (N = 37) or single-sided deafness (N = 13) were enrolled prospectively and followed to 12 months post-surgery. Intraoperative findings were collected via surgeon questionnaire. Safety outcomes included adverse events/complications tracked out to 12 months post-surgery. Efficacy outcomes included hearing sensitivity, speech perception in quiet and noise, hours of use, retention, and a parental questionnaire.

RESULTS

Fifty subjects were implanted. Forty-nine subjects completed the trial through the 12-month post-implantation endpoint. Surgical bone stock was good in all subjects. Bone bed polishing was required in 36%. 34% (N = 17/50) reported a procedure and/or device-related adverse event. The majority of these were minor and expected issues postoperatively. No patients required explant. Patients experienced statistically significant improvements in word scores (CNC), speech in noise testing (BKB-SIN), and pure tone averages at 6 months post-implantation compared to the pre-surgical unaided condition. Retention scores were good at the study endpoint. Mean daily use was 9.8 +/- 3.2 h/day.

CONCLUSION

The data from this trial suggest the Osia 2 system is safe and effective to use in children aged 5-11. FDA clearance for this new age indication was approved in spring 2024.

TRIAL REGISTRATION: This study was part of a Multi-center prospective trial, submitted to and approved by the FDA (Clinicaltrials.gov number: NCT05000931; FDA IDE number: G2000325).