Comprehensive Audiological Outcomes of the Osia 2 System: A Prospective, Single-Arm Clinical Study

OBJECTIVE: To investigate the audiological benefits and surgical outcomes of Osia 2 System implantation in patients with conductive and mixed hearing loss (CHL and MHL), over a 6-month follow-up. DESIGN: Prospective, single-arm clinical study. SETTING: Single tertiary hospital. PATIENTS: Eighteen patients with CHL or MHL who are unable to use hearing aids, between May 2023 and July 2024. INTERVENTION: Osia 2 implantation through a minimal incision along the hairline. MAIN OUTCOMES AND MEASURES: Audiological evaluations including pure tone audiometry (PTA), speech audiometry (SA), recognition of hearing in noise tests (HINT), sound localization tests (LT), and the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. Surgical outcomes and complications were also assessed preoperatively and postoperatively. RESULTS: Of the 18 patients (11 men; mean age: 61.94 y), 15 had implantation alone (mean operation time: 53.67±10.43 min), and 13 under local anesthesia. No complications were observed. Significant improvements in aided PTA, with a gain of 35.56±22.22 dB HL at 4 kHz one month postoperatively. In SA, the mean speech recognition threshold, most comfortable level, and speech discrimination score also improved. In the HINT, the signal-to-noise ratio improved with various noise and stimulus orientations. In the LT, localization ability improved when stimuli were from the implant side. The APHAB score improved over time. CONCLUSIONS: The Osia 2 System provides effective audiological improvements in patients with CHL or MHL, unable to use hearing aids. With high-frequency amplification through a piezoelectric actuator and a minimal incision technique, the Osia 2 System offers reliable performance and safety.