Remote Programming of Cochlear Implants.

OBJECTIVE: This study investigated the safety and efficacy of remote programming of cochlear implants. STUDY DESIGN: Single-subject design SETTING:: Four North American clinical sites PATIENTS:: Forty cochlear implant recipients aged 12 years or older INTERVENTION:: Subjects had their cochlear implants programmed at a location that was remote from their audiologist using telecommunication with and without the support of a facilitator. MAIN OUTCOME MEASURES: Consonant-Nucleus-Consonant (CNC) word scores and the Speech, Spatial, and Qualities of Hearing Scale-C (SSQ-C) were compared using the subject's in-office MAP (program) and MAPs programmed remotely with and without the assistance of a facilitator. Additional subjective preference data were gathered from subjects and audiologists via questionnaires. RESULTS: MAPs programmed via the three different models did not yield significantly different group mean CNC word scores. No device/procedure-related adverse events occurred. SSQ-C questionnaire results indicated that recipients received similar subjective benefit from familiar in-office, remote-facilitated, and remote-unassisted MAPs. CONCLUSIONS: Remote programming is an effective means of cochlear implant service delivery. The practice was approved by the FDA on November 17, 2017 supported by the results of this study.

Multicenter US Clinical Trial With an Electric-Acoustic Stimulation (EAS) System in Adults: Final Outcomes.

OBJECTIVE: To demonstrate the safety and effectiveness of the MED-EL Electric-Acoustic Stimulation (EAS) System, for adults with residual low-frequency hearing and severe-to-profound hearing loss in the mid to high frequencies. STUDY DESIGN: Prospective, repeated measures. SETTING: Multicenter, hospital. PATIENTS: Seventy-three subjects implanted with PULSAR or SONATA cochlear implants with FLEX electrode arrays. INTERVENTION: Subjects were fit postoperatively with an audio processor, combining electric stimulation and acoustic amplification. MAIN OUTCOME MEASURES: Unaided thresholds were measured preoperatively and at 3, 6, and 12 months postactivation. Speech perception was assessed at these intervals using City University of New York sentences in noise and consonant-nucleus-consonant words in quiet. Subjective benefit was assessed at these intervals via the Abbreviated Profile of Hearing Aid Benefit and Hearing Device Satisfaction Scale questionnaires. RESULTS: Sixty-seven of 73 subjects (92%) completed outcome measures for all study intervals. Of those 67 subjects, 79% experienced less than a 30 dB HL low-frequency pure-tone average (250-1000 Hz) shift, and 97% were able to use the acoustic unit at 12 months postactivation. In the EAS condition, 94% of subjects performed similarly to or better than their preoperative performance on City University of New York sentences in noise at 12 months postactivation, with 85% demonstrating improvement. Ninety-seven percent of subjects performed similarly or better on consonant-nucleus-consonant words in quiet, with 84% demonstrating improvement. CONCLUSION: The MED-EL EAS System is a safe and effective treatment option for adults with normal hearing to moderate sensorineural hearing loss in the low frequencies and severe-to-profound sensorineural hearing loss in the high frequencies who do not benefit from traditional amplification.