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

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 Miyamoto, Douglas D. Backous, Frank M. Warren, Hussam K. El-KashlanHeidi K. Slager, Carisa Reyes, Allison I. Racey, Oliver F. Adunka

Research output: Contribution to journalArticle

12 Citations (Scopus)

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 24 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.

Original languageEnglish (US)
Pages (from-to)299-305
Number of pages7
JournalOtology and Neurotology
Volume39
Issue number3
DOIs
StatePublished - Mar 1 2018

Fingerprint

Acoustic Stimulation
Electric Stimulation
Clinical Trials
Hearing
Sensorineural Hearing Loss
Acoustics
Noise
Outcome Assessment (Health Care)
Speech Perception
Hearing Aids
Cochlear Implants
Hearing Loss
Electrodes
Prospective Studies
Safety
Equipment and Supplies
Therapeutics

Keywords

  • Cochlear implant
  • Electric-acoustic stimulation
  • Hearing preservation
  • Hybrid cochlear implant

ASJC Scopus subject areas

  • Otorhinolaryngology
  • Sensory Systems
  • Clinical Neurology

Cite this

Pillsbury, H. C., DIllon, M. T., Buchman, C. A., Staecker, H., Prentiss, S. M., Ruckenstein, M. J., ... Adunka, O. F. (2018). Multicenter US Clinical Trial with an Electric-Acoustic Stimulation (EAS) System in Adults: Final Outcomes. Otology and Neurotology, 39(3), 299-305. https://doi.org/10.1097/MAO.0000000000001691

Multicenter US Clinical Trial with an Electric-Acoustic Stimulation (EAS) System in Adults : Final Outcomes. / Pillsbury, Harold C.; DIllon, Margaret T.; Buchman, Craig A.; Staecker, Hinrich; Prentiss, Sandra M.; Ruckenstein, Michael J.; Bigelow, Douglas C.; Telischi, Fred F.; Martinez, DIane M.; Runge, Christina L.; Friedland, David R.; Blevins, Nikolas H.; Larky, Jannine B.; Alexiades, George; Kaylie, David M.; Roland, Peter S.; Miyamoto, Richard; Backous, Douglas D.; Warren, Frank M.; El-Kashlan, Hussam K.; Slager, Heidi K.; Reyes, Carisa; Racey, Allison I.; Adunka, Oliver F.

In: Otology and Neurotology, Vol. 39, No. 3, 01.03.2018, p. 299-305.

Research output: Contribution to journalArticle

Pillsbury, HC, DIllon, MT, Buchman, CA, Staecker, H, Prentiss, SM, Ruckenstein, MJ, Bigelow, DC, Telischi, FF, Martinez, DIM, Runge, CL, Friedland, DR, Blevins, NH, Larky, JB, Alexiades, G, Kaylie, DM, Roland, PS, Miyamoto, R, Backous, DD, Warren, FM, El-Kashlan, HK, Slager, HK, Reyes, C, Racey, AI & Adunka, OF 2018, 'Multicenter US Clinical Trial with an Electric-Acoustic Stimulation (EAS) System in Adults: Final Outcomes', Otology and Neurotology, vol. 39, no. 3, pp. 299-305. https://doi.org/10.1097/MAO.0000000000001691
Pillsbury, Harold C. ; DIllon, Margaret T. ; Buchman, Craig A. ; Staecker, Hinrich ; Prentiss, Sandra M. ; Ruckenstein, Michael J. ; Bigelow, Douglas C. ; Telischi, Fred F. ; Martinez, DIane M. ; Runge, Christina L. ; Friedland, David R. ; Blevins, Nikolas H. ; Larky, Jannine B. ; Alexiades, George ; Kaylie, David M. ; Roland, Peter S. ; Miyamoto, Richard ; Backous, Douglas D. ; Warren, Frank M. ; El-Kashlan, Hussam K. ; Slager, Heidi K. ; Reyes, Carisa ; Racey, Allison I. ; Adunka, Oliver F. / Multicenter US Clinical Trial with an Electric-Acoustic Stimulation (EAS) System in Adults : Final Outcomes. In: Otology and Neurotology. 2018 ; Vol. 39, No. 3. pp. 299-305.
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AU - Pillsbury, Harold C.

AU - DIllon, Margaret T.

AU - Buchman, Craig A.

AU - Staecker, Hinrich

AU - Prentiss, Sandra M.

AU - Ruckenstein, Michael J.

AU - Bigelow, Douglas C.

AU - Telischi, Fred F.

AU - Martinez, DIane M.

AU - Runge, Christina L.

AU - Friedland, David R.

AU - Blevins, Nikolas H.

AU - Larky, Jannine B.

AU - Alexiades, George

AU - Kaylie, David M.

AU - Roland, Peter S.

AU - Miyamoto, Richard

AU - Backous, Douglas D.

AU - Warren, Frank M.

AU - El-Kashlan, Hussam K.

AU - Slager, Heidi K.

AU - Reyes, Carisa

AU - Racey, Allison I.

AU - Adunka, Oliver F.

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N2 - 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 24 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.

AB - 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 24 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.

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