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Published on: July 15, 2009
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Active Osseointegrated Steady-State Implant System: Surgical and Clinical Performance
Leornardo Ordoñez-Ordoñez1, José Agustin Caraballo, Jorge Guillermo Cabrera Ortiz
1Hospital Militar Central, Universidad Militar Nueva Granada, Bogotá, Colombia.
Summary
This study shows an active osseointegration implant with piezoelectric technology is safe and effective for hearing loss conditions. Patients experienced significant hearing improvements and benefits after surgery.
Area of Science:
- Otolaryngology
- Biomedical Engineering
- Audiology
Background:
- Osseointegrated implants offer solutions for hearing loss.
- Piezoelectric technology presents a novel approach for active bone conduction implants.
Purpose of the Study:
- To evaluate the surgical outcomes and clinical performance of a new active osseointegration implant system utilizing piezoelectric technology.
- To assess the safety and efficacy of this innovative hearing implant.
Main Methods:
- A national, multicenter, prospective study included patients with conductive hearing loss (CHL), mixed hearing loss (MHL), or single-sided deafness (SSD).
- Surgical parameters, functional gain (FG), effective gain (EG), and subjective benefits via the Client Oriented Scale of Improvement (COSI) questionnaire were assessed post-activation.
Main Results:
- 580 patients (ages 5-73) were enrolled. Mean surgery duration was 54 minutes.
- Significant functional gain was observed: 38.6 dB (CHL), 44.4 dB (MHL), and 66.1 dB (SSD).
- 11.4% of surgeries involved converting existing devices to the piezoelectric system.
Conclusions:
- The active transcutaneous bone conduction implant with piezoelectric transducer is clinically safe and performs well.
- This technology offers significant benefits for patients with CHL, MHL, or SSD.
- The study confirms the effectiveness of this innovative hearing implant solution.
