Journal article

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

Emmanuel AM Mylanus, Hakan Hua, Stina Wigren, Susan Arndt, Piotr Henryk Skarzynski, Steven A Telian, Robert JS Briggs

Otology and Neurotology: an international forum | LIPPINCOTT WILLIAMS & WILKINS | Published : 2020

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..

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