Electric-Acoustic Stimulation Extended Follow-up Post Approval Study

August 24, 2020 updated by: Med-El Corporation

Office of Device Evaluation Lead-MED-EL EAS Extended f/u Study

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Palo Alto, California, United States, 94303
        • Stanford Unversity
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas University Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • University of North Carolina
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Hospital of the University of Pennsylvania
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College Of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Study procedures
Combination of a cochlear implant and a hearing aid
Other Names:
  • EAS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
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.
Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
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.
Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

January 13, 2017

First Submitted That Met QC Criteria

January 23, 2017

First Posted (Estimate)

January 25, 2017

Study Record Updates

Last Update Posted (Actual)

September 10, 2020

Last Update Submitted That Met QC Criteria

August 24, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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