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Updated: Dec 9, 2025
Bioelectric Analyses of an Osseointegrated Intelligent Implant Design System for Amputees
Published on: July 15, 2009
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.
Objective:
A new active transcutaneous bone conduction hearing implant system that uses piezoelectric technology has been developed: an active osseointegrated steady-state implant system (OSI). This was the first clinical investigation undertaken to demonstrate clinical performance, safety, and benefit of the new implant system.
Study Design And Setting:
A multicenter prospective within-subject clinical investigation was conducted.
Patients:
Fifty-one adult subjects with mixed and conductive hearing loss (MHL/CHL, n = 37) and single-sided sensorineural deafness (SSD, n = 14) were included.
Main Outcome Measure:
Audiological evaluations included audiometric thresholds, speech recognition in noise, and quiet. Hearing and health-related patient-reported outcomes (PROs; health utilities index [HUI], abbreviated profile of hearing aid benefit [APHAB], and speech, spatial of qualities of hearing scale [SSQ]), daily use, surgical and safety parameters were collected.
Results:
Intra- and postoperative complications were few. One implant was removed before activation due to post-surgical infection. Compared with the preoperative softband tests, a significant improvement in speech recognition-in-noise was observed in the MHL/CHL group (-7.3 dB, p ≤ 0.0001) and the SSD group (-8.1 dB, p = 0.0008). In quiet, word recognition improved in the MHL/CHL group, most markedly at lower intensity input of 50 dB SPL (26.7%, p ≤ 0.0001). The results of all PROs showed a significant improvement with the new device compared with preoperative softband in the MHL/CHL group. In the SSD group significant improvements were observed in the APHAB and SSQ questionnaires.
Discussion:
The results confirmed the clinical safety, performance, and benefit of this new treatment modality for subjects with CHL, MHL, and SSD.
