Faculty Collaboration Database

Multicenter US Clinical Trial With an Electric-Acoustic Stimulation (EAS) System in Adults: Final Outcomes. Otol Neurotol 2018 Mar;39(3):299-305

Date

01/18/2018

Pubmed ID

29342054

Pubmed Central ID

PMC5821485

DOI

10.1097/MAO.0000000000001691

Scopus ID

2-s2.0-85042489455 (requires institutional sign-in at Scopus site)   76 Citations

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.

Author List

Pillsbury HC 3rd, Dillon MT, Buchman CA, Staecker H, Prentiss SM, Ruckenstein MJ, Bigelow DC, Telischi FF, Martinez DM, Runge CL, Friedland DR, Blevins NH, Larky JB, Alexiades G, Kaylie DM, Roland PS, Miyamoto RT, Backous DD, Warren FM, El-Kashlan HK, Slager HK, Reyes C, Racey AI, Adunka OF

Authors

David R. Friedland MD Associate Director, Director, Chief, Professor in the Otolaryngology department at Medical College of Wisconsin
Christina Runge PhD Associate Provost, Chief, Professor in the Otolaryngology department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Acoustic Stimulation
Adolescent
Adult
Aged
Cochlear Implantation
Cochlear Implants
Female
Hearing Aids
Hearing Loss, Sensorineural
Humans
Male
Middle Aged
Prospective Studies
Speech Perception
Surveys and Questionnaires
Treatment Outcome
Young Adult