SS06: ACTIVE MIDDLE EAR IMPLANTS AND MHL

OTOLOGICS FULLY IMPLANTABLE HEARING DEVICE PHASE II CLINICAL TRIALS

Jenkins HA, Lupo V, Claycomb S.

University of Colorado Denver School of Medicine, USA.

Abstract: Objectives: In this pivotal FDA clinical trial efficacy of the Otologics Fully-Implantable MET Hearing Device was assessed in adult patients with bilateral moderate to severe sensorineural hearing loss. 

Methods: The totally implanted electromechanical transducer tip was coupled to the incus, via insertion into a laser-drilled hole, followed by post auricular implantation of the microphone/battery/electronics capsule.  A repeated-measures within-subjects design assessed aided sound field thresholds, speech performances and subjective benefit with the subject’s own, appropriately fit, walk-in hearing aid(s) and the Otologics Fully-Implantable Hearing Device.

Results: Twenty of the fifty patients necessary for regulatory submission have been implanted. Two and three month data will be presented and compared to the patient’s walk-in hearing aid.  No significant differences between preoperative (AC = 57 dB, BC = 53 dB) and postoperative (AC = 62 dB, BC = 56 dB) unaided pure tone averages were noted (p > 0.05).  Pure tone average implant aided thresholds (43 dB) were equivalent to that of walk-in-aided (38 dB) condition with no significant differenced (p < 0.05) between patients’ walk-in-aided individual frequency thresholds and implant-aided thresholds. Word recognition scores and hearing in noise scores were similar between the walk-in-aided and for the implant-aided condition.  Patient benefit scales, assessed with the APHAB, showed a preference for the implanted device in all situations, except for similar ratings in aversiveness.  Incremental improvements occurred with time postoperatively as the wound sites matured.

Conclusions: Preliminary results of the Otologics MET Fully-Implantable Hearing Device Pivotal trial provide evidence that this fully implantable is equivalent to currently available hearing aids in patients with moderate to severe sensorineural hearing loss.