Acute Human Trial of the Floating Mass Transducer

Abstract

Five patients underwent acute implantation of the Floating Mass Transducer™ (FMT™) to evaluate the ability of the FMT to produce measurable auditory thresholds when temporarily placed in the middle ears of patients undergoing routine stapedotomy procedures. The FMT was placed on the long process of the incus in an inferior position, as is planned for clinical application, and in two additional positions. The ability of the FMT to produce measurable auditory thresholds was demonstrated in all patients. Results were affected by the lack of a healing period, the presence of a fixed stapes and an open middle ear space, and patient sedation.