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Multicenter Clinical Investigation of a New Active Osseointegrated Steady-State Implant System
Emmanuel A M Mylanus1, Håkan Hua2, Stina Wigren2
1Department of Otorhinolaryngology, Donders Center for Neurosciences, Radboud university medical center, Nijmegen, The Netherlands.
Summary
A new piezoelectric bone conduction hearing implant system demonstrated significant improvements in speech recognition for patients with conductive, mixed, and single-sided deafness. This innovative active osseointegrated steady-state implant system (OSI) offers a safe and effective new treatment option.
Area of Science:
- Otolaryngology
- Biomedical Engineering
- Audiology
Background:
- Conductive hearing loss (CHL), mixed hearing loss (MHL), and single-sided deafness (SSD) significantly impact quality of life.
- Existing bone conduction hearing solutions have limitations.
- A novel active osseointegrated steady-state implant system (OSI) utilizing piezoelectric technology has been developed.
Purpose of the Study:
- To evaluate the clinical performance, safety, and benefit of the new OSI system.
- To assess audiological outcomes and patient-reported outcomes (PROs) in subjects with CHL/MHL and SSD.
- To compare the OSI system's efficacy against preoperative softband test results.
Main Methods:
- A multicenter prospective within-subject clinical investigation.
- Inclusion of 51 adult subjects with CHL/MHL (n=37) and SSD (n=14).
- Comprehensive audiological evaluations and PRO assessments (HUI, APHAB, SSQ), alongside surgical and safety monitoring.
Main Results:
- The OSI system showed a significant improvement in speech recognition in noise for both MHL/CHL and SSD groups (p≤0.0001).
- Word recognition in quiet improved significantly in the MHL/CHL group (26.7% at 50 dB SPL, p≤0.0001).
- All PROs indicated significant improvements with the OSI system in the MHL/CHL group, and APHAB/SSQ showed improvements in the SSD group.
Conclusions:
- The OSI system is clinically safe and effective for treating CHL, MHL, and SSD.
- This piezoelectric-driven active bone conduction implant represents a beneficial new treatment modality.
- The study confirms the OSI system's potential to enhance hearing outcomes and patient quality of life.
