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Comprehensive Audiological Outcomes of the Osia 2 System: A Prospective, Single-Arm Clinical Study
Hyun Su Lee1,2, Tae Hoon Kong2,3, Young Joon Seo2,3
1Department of Convergence Medicine, Yonsei University Wonju College of Medicine.
The Osia 2 System significantly improves hearing for patients with conductive or mixed hearing loss who cannot use hearing aids. This implant offers reliable performance and safety through advanced piezoelectric technology and a minimally invasive approach.
Area of Science:
- Otolaryngology
- Audiology
- Biomedical Engineering
Background:
- Conductive hearing loss (CHL) and mixed hearing loss (MHL) can significantly impair quality of life.
- Traditional hearing aids are not suitable for all patients with CHL and MHL.
- The Osia 2 System offers a potential solution for these individuals.
Purpose of the Study:
- To evaluate the audiological benefits of the Osia 2 System in patients with CHL and MHL.
- To assess surgical outcomes and complications associated with Osia 2 System implantation.
- To determine the efficacy over a 6-month follow-up period.
Main Methods:
- Prospective, single-arm clinical study at a tertiary hospital.
- Eighteen patients with CHL/MHL, unsuitable for hearing aids, underwent Osia 2 implantation.
- Audiological tests (PTA, SA, HINT, LT, APHAB) and surgical assessments were performed pre- and post-operatively.
Main Results:
- Significant improvements in aided pure tone audiometry (PTA) at 4 kHz (35.56 dB HL gain).
- Enhanced speech audiometry (SA) including speech recognition thresholds and discrimination scores.
- Improved hearing in noise (HINT), sound localization (LT), and patient-reported outcomes (APHAB).
- No surgical complications were observed in the study cohort.
Conclusions:
- The Osia 2 System demonstrates effective audiological improvements for CHL and MHL patients.
- The system utilizes piezoelectric actuation for high-frequency amplification.
- Minimal incision technique and Osia 2 System implantation show reliable performance and safety.
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