Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Electric-Acoustic Stimulation Extended Follow-up Post Approval Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031678
Recruitment Status : Completed
First Posted : January 25, 2017
Results First Posted : September 10, 2020
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Med-El Corporation

Brief Summary:
The MED-EL EAS Extended Follow-up Study is an extended follow-up of the subjects who were enrolled in the pivotal study to assess long-term safety and device performance.

Condition or disease Intervention/treatment Phase
Hearing Loss, Sensorineural Device: Electric-Acoustic Stimulation (EAS) Cochlear Implant System Not Applicable

Detailed Description:
The study will be conducted as a prospective, non-controlled, non-randomized, multicenter study at the 14 sites. Up to 68 available subjects who were enrolled in the pivotal study will be invited to participate in the extended follow-up. Study subjects will be followed for a minimum of 5 years post-implantation of the device.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Office of Device Evaluation Lead-MED-EL EAS Extended f/u Study
Study Start Date : December 2016
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Study procedures Device: Electric-Acoustic Stimulation (EAS) Cochlear Implant System
Combination of a cochlear implant and a hearing aid
Other Name: EAS




Primary Outcome Measures :
  1. Percentage of Words Correct As Assessed by CUNY Sentence Test. [ Time Frame: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial ]
    Long-term effectiveness of the Electric-Acoustic System will be assessed by speech perception testing in noise with CUNY sentences completed through five years post-implantation.


Secondary Outcome Measures :
  1. Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE. [ Time Frame: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial ]
    The HEARRING Scale was developed by the HEARRING Research Group, a collaboration of surgeons and audiologists in the hearing implant field who work together to develop consensus statements. The Scale was published in 2013 by Skarzynski et al. as means to classify post-operative residual hearing thresholds. Residual hearing is classified as complete (100-76%), partial (26-75%), minimal (1-25%), or none (0%) according to an equation which takes into account pre-operative thresholds, post-operative thresholds, and the limits of the audiometer.

  2. Percentage of Words Correct as Assessed by CNC Words in Quiet. [ Time Frame: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial ]
    Long-term effectiveness of the Electric-Acoustic System will be assessed by speech perception testing in quiet with CNC words completed through five years post-implantation.

  3. Subjective Benefit From EAS Through 5 Years Post Implantation Measured on the APHAB (Abbreviated Profile Hearing Aid Benefit) Questionnaire. [ Time Frame: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial ]
    The APHAB Questionnaire measures percentage of listening difficulty on a scale from 100% (very difficult) to 0% (not difficult at all). Results are reported as the average listening difficulty across subjects.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older at the time of implantation
  • Severe to profound sensorineural hearing loss for frequencies greater than 1500 Hz (i.e., threshold no better than 70 dB HL at 2000-8000 Hz)
  • Low-frequency thresholds up to and including 500 Hz no poorer than 65 dB HL
  • CNC word recognition score less than or equal to 60% in the ear to be implanted
  • CNC word recognition score less than or equal to 60% in the contralateral ear
  • English spoken as the primary language

Exclusion Criteria:

  • Conductive, retrocochlear, or central auditory disorder
  • Hearing loss in the ear to be implanted that has demonstrated a recent fluctuation at two or more frequencies of 15 dB in either direction in the last 2 years
  • Any physical, psychological, or emotional disorder that interferes with surgery or the ability to perform on test and rehabilitation procedures
  • Developmental delays or organic brain dysfunction
  • Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations
  • Unwillingness or inability of the candidate to comply with all investigational requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031678


Locations
Layout table for location information
United States, California
Stanford Unversity
Palo Alto, California, United States, 94303
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Kansas
University of Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27517
United States, Pennsylvania
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Med-El Corporation
  Study Documents (Full-Text)

Documents provided by Med-El Corporation:
Publications:
Layout table for additonal information
Responsible Party: Med-El Corporation
ClinicalTrials.gov Identifier: NCT03031678    
Other Study ID Numbers: P000025/PAS001
First Posted: January 25, 2017    Key Record Dates
Results First Posted: September 10, 2020
Last Update Posted: September 10, 2020
Last Verified: August 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases