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Updated: Sep 3, 2025
Bioelectric Analyses of an Osseointegrated Intelligent Implant Design System for Amputees
Published on: July 15, 2009
Clinical Performance, Safety, and Patient-Reported Outcomes of an Active Osseointegrated Steady-State Implant System
Robert Briggs1, Catherine S Birman2, Nicholas Baulderstone2
1Department of Otolaryngology, The University of Melbourne, Melbourne.
Objective:
To investigate the clinical performance, safety, and patient-reported outcomes of an active osseointegrated steady-state implant system that uses piezoelectric technology.
Study Design:
A prospective, multicenter, open-label, single-arm, within-subject clinical investigation.
Setting:
Three tertiary referral clinical centers located in Melbourne, Sydney, and Hong Kong.
Patients:
Twenty-nine adult subjects, 24 with mixed hearing loss or conductive hearing loss and 5 with single-sided sensorineural deafness.
Intervention:
Implantation with the Cochlear Osia 2 System.
Main Outcome Measures:
Audiological threshold evaluation and speech recognition in quiet and in noise. Patient satisfaction and safety.
Results:
At 6-month follow-up after surgery, a mean improvement in pure-tone average of 26.0 dB hearing level and a mean improvement of 8.8 dB signal-to-noise ratio in speech reception threshold in noise was achieved with the investigational device as compared with the unaided situation. Usability of the investigational device was rated 71.4/100 mm for sound processor retention and 81.4/100 mm for overall comfort using a visual analog scale.
Conclusion:
These outcomes confirm the clinical safety, performance, and benefit of an innovative active transcutaneous bone conduction implant using a piezoelectric transducer design in subjects with conductive hearing loss, mixed hearing loss, or single-sided sensorineural deafness.
