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

Autor: Diane Martinez, George Alexiades, Allison I. Racey, Hinrich Staecker, Douglas D. Backous, Hussam K. El-Kashlan, David R. Friedland, Frank M. Warren, Craig A. Buchman, David M. Kaylie, Carisa Reyes, Michael J. Ruckenstein, Richard T. Miyamoto, Christina L. Runge, Peter S. Roland, Oliver F. Adunka, Douglas C. Bigelow, Margaret T. Dillon, Heidi K. Slager, Harold C. Pillsbury, Sandra M. Prentiss, Nikolas H. Blevins, Jannine Larky, Fred F. Telischi
Rok vydání: 2018
Předmět:
Adult
Male
Hybrid cochlear implant
Electric acoustic stimulation
medicine.medical_specialty
Adolescent
Hearing loss
Hearing Loss
Sensorineural
medicine.medical_treatment
Treatment outcome
Young Adult
03 medical and health sciences
Hearing Aids
0302 clinical medicine
Physical medicine and rehabilitation
Surveys and Questionnaires
Cochlear implant
otorhinolaryngologic diseases
medicine
Humans
Prospective Studies
030223 otorhinolaryngology
Cochlear implantation
Prospective cohort study
Aged
business.industry
Middle Aged
Cochlear Implantation
Sensory Systems
Clinical trial
Cochlear Implants
Treatment Outcome
Acoustic Stimulation
Otorhinolaryngology
Multicenter study
Speech Perception
Electric-acoustic stimulation
Female
Neurology (clinical)
Hearing preservation
medicine.symptom
business
030217 neurology & neurosurgery
Zdroj: Otology & Neurotology
ISSN: 1537-4505
1531-7129
DOI: 10.1097/mao.0000000000001691
Popis: 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 FLEX24 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.
Databáze: OpenAIRE
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