Patient selection for incus body coupling of a totally implantable middle ear implant.

Objective—To evaluate audiologic selection criteria for incus body coupling (IBC) of a totally implantable middle ear implant (TI-MEI) for the treatment of sensorineural hearing loss (SNHL). Material and Methods—The protocol is specified in the Investigational Device Exemption of a Food and Drug Administration-approved multicenter clinical trial. The prospective study compared pre- and postoperative hearing levels using each patient as their own control. In addition, an implant on/off comparison was made. All patients had a follow-up interval of at least 6 months. Audiologic assessment tests included speech discrimination in quiet as the primary efficacy variable and pure-tone audiometry (aided thresholds), gain, speech recognition in noise and subject satisfaction using standardized questionnaires and visual analog scales (VASs) as secondary efficacy variables. The study group of patients (n = 13) was divided into 3 subgroups based on their pure-tone and speech discrimination scores: Group A consisted of...