Multicenter US Clinical Trial With an Electric-Acoustic Stimulation (EAS) System in Adults: Final Outcomes
Year: 2018
Type: article
Study design: Clinical Trial
Abstract: 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.
Source: Otology & Neurotology
Authors: Harold C. Pillsbury, Margaret T. Dillon, Craig A. Buchman, Hinrich Staecker, Sandra M. Prentiss, Michael J. Ruckenstein, Douglas C. Bigelow, Fred F. Telischi, Diane M. Martinez, Christina L. Runge, David R. Friedland, Nikolas H. Blevins, Jannine B. Larky, George Alexiades, David M. Kaylie, Peter S. Roland, Richard T. Miyamoto, Douglas D. Backous, Frank M. Warren, Hussam K. El-Kashlan, Heidi K. Slager, Carisa Reyes, Allison I. Racey, Oliver F. Adunka
Institutions: University of North Carolina at Chapel Hill, University of Kansas Medical Center, Hospital of the University of Pennsylvania, University of Miami, Medical College of Wisconsin, Stanford University, New York Eye and Ear Infirmary, Duke University, The University of Texas Southwestern Medical Center, Indiana University Hospital, Indiana University Indianapolis, Swedish Medical Center, Oregon Health & Science University, University of Michigan, Boys Town National Research Hospital
Language: English
Subfield: Cognitive Neuroscience
Field: Neuroscience
Domain: Life Sciences
Open Access status: hybrid
OpenAlex ID: W2793131691