Multicenter US Clinical Trial With an Electric-Acoustic Stimulation (EAS) System in Adults: Final Outcomes
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- Harold C. Pillsbury
- Department of Otolaryngology/Head and Neck Surgery, University of North Carolina School of Medicine, Chapel Hill, North Carolina
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- Margaret T. Dillon
- Department of Otolaryngology/Head and Neck Surgery, University of North Carolina School of Medicine, Chapel Hill, North Carolina
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- Craig A. Buchman
- Department of Otolaryngology/Head and Neck Surgery, University of North Carolina School of Medicine, Chapel Hill, North Carolina
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- Hinrich Staecker
- Department of Otolaryngology—Head and Neck Surgery, Kansas University Medical Center, Kansas City, Kansas
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- Sandra M. Prentiss
- Department of Otolaryngology—Head and Neck Surgery, Kansas University Medical Center, Kansas City, Kansas
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- Michael J. Ruckenstein
- Department of Otorhinolaryngology—Head and Neck Surgery, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
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- Douglas C. Bigelow
- Department of Otorhinolaryngology—Head and Neck Surgery, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
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- Fred F. Telischi
- Department of Otolaryngology, Miller School of Medicine of the University of Miami, Miami, Florida
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- Diane M. Martinez
- Department of Otolaryngology, Miller School of Medicine of the University of Miami, Miami, Florida
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- Christina L. Runge
- Department of Otolaryngology and Communication Sciences, Medical College of Wisconsin, Milwaukee, Wisconsin
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- David R. Friedland
- Department of Otolaryngology and Communication Sciences, Medical College of Wisconsin, Milwaukee, Wisconsin
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- Nikolas H. Blevins
- Department of Otolaryngology—Head and Neck Surgery, Stanford University, Palo Alto, California
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- Jannine B. Larky
- Department of Otolaryngology—Head and Neck Surgery, Stanford University, Palo Alto, California
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- George Alexiades
- Department of Otolaryngology, New York Eye and Ear Infirmary, New York, New York
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- David M. Kaylie
- Duke Otolaryngology, Head and Neck, ENT, and Oral Surgery, Duke University, Durham, North Carolina
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- Peter S. Roland
- Department of Otolaryngology—Head and Neck Surgery, University of Texas Southwestern Medical Center, Dallas, Texas
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- Richard T. Miyamoto
- Department of Otolaryngology—Head and Neck Surgery, Indiana University, Indianapolis, Indiana
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- Douglas D. Backous
- Center for Hearing and Skull Base Surgery, Swedish Neuroscience Institute, Seattle, Washington
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- Frank M. Warren
- Department of Otolaryngology—Head and Neck Surgery Oregon Health Sciences University, Portland, Oregon
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- Hussam K. El-Kashlan
- Department of Otolaryngology—Head and Neck Surgery Michigan University, Ann Arbor, Michigan
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- Heidi K. Slager
- Department of Otolaryngology—Head and Neck Surgery Michigan University, Ann Arbor, Michigan
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- Carisa Reyes
- Boys Town National Research Hospital, Omaha, Nebraska
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- Allison I. Racey
- MED-EL Corporation, Durham, North Carolina
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- Oliver F. Adunka
- Department of Otolaryngology/Head and Neck Surgery, University of North Carolina School of Medicine, Chapel Hill, North Carolina
抄録
<jats:sec> <jats:title>Objective:</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Study Design:</jats:title> <jats:p>Prospective, repeated measures.</jats:p> </jats:sec> <jats:sec> <jats:title>Setting:</jats:title> <jats:p>Multicenter, hospital.</jats:p> </jats:sec> <jats:sec> <jats:title>Patients:</jats:title> <jats:p>Seventy-three subjects implanted with PULSAR or SONATA cochlear implants with FLEX<jats:sup>24</jats:sup> electrode arrays.</jats:p> </jats:sec> <jats:sec> <jats:title>Intervention:</jats:title> <jats:p>Subjects were fit postoperatively with an audio processor, combining electric stimulation and acoustic amplification.</jats:p> </jats:sec> <jats:sec> <jats:title>Main Outcome Measures:</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Results:</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusion:</jats:title> <jats:p>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.</jats:p> </jats:sec>
収録刊行物
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- Otology & Neurotology
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Otology & Neurotology 39 (3), 299-305, 2018-03
Ovid Technologies (Wolters Kluwer Health)