Middle ear electromagnetic implantable hearing device - Initial clinical results

This article describes the authors' recent experiences with electromagnetic middle ear hearing devices and introduces a new device, the SOUNDTEC (TM) Direct Drive Hearing System (DDHS). A description of the device, details of the surgical procedure and results of a five-subject Food and Drug Administration (FDA) feasibility study are included. The system is composed of two elements: an neodymium iron boron (NdFeBo) magnet implant encased in a titanium laser-welded cylinder, and an external portion composed of a behind the ear (BTE) sound processor/coil assembly. The implant is secured around the incudo-stapedial joint via a titanium wireform. Outcome measures six months postoperatively were compared to preoperative baseline data in four subjects. Significant improvements in high frequency functional gain (16 dB increase for high frequency warble tone average (HFWTA)), speech discrimination (18.5% increase), functional absence of acoustic feedback, reduced occlusive effect, as well as significant improvement in subjective measures of patient satisfaction, were noted with the SOUNDTEC DDHS when compared to results achieved with a well-fitted hearing aid.