Multicenter Clinical Investigation of a New Active Osseointegrated Steady-State Implant System

Abstract

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 n..