Working... Menu

Reverberation Effects on MED-EL Recipients

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. Identifier: NCT03143296
Recruitment Status : Enrolling by invitation
First Posted : May 8, 2017
Last Update Posted : May 2, 2019
Information provided by (Responsible Party):
Sandra Prentiss, University of Miami

Brief Summary:
The purpose of this study is to investigate speech understanding in simulated reverberant environments with MED-EL cochlear implant recipients.

Condition or disease
Hearing Loss, Sensorineural

Detailed Description:
The study will determine if electrode length and coding strategy effect performance. We will also study performance over time with new recipients.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects of Reverberation on Speech Understanding in MED-EL Cochlear Implant Recipients
Actual Study Start Date : August 16, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Electrode length and performance [ Time Frame: Two hours ]
    Percent correct on simulated reverberant speech test as a factor of electrode length

  2. Coding strategy and performance [ Time Frame: Two hours ]
    Speech scores, in percent correct, recorded from simulated reverberant speech tests will be compared between fine structure and envelope coding strategies.

  3. Performance over time in reverberant situations [ Time Frame: Six months ]
    Outcomes in reverberant situations will be tested over the course of 6 months

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
Sampling Method:   Non-Probability Sample
Study Population
Current Med-EL recipients with a minimum of 6-month experience and new recipients will be included in the study

Inclusion Criteria:

  • MED-EL current cochlear implant recipients of the Flex 24 or 28 will be included
  • Minimum of 6 months experience with their cochlear implant
  • Minimum of 10 new adult Med-El recipients of the Flex 24 or Flex 28 electrodes
  • Patient at the University of Miami

Exclusion Criteria:

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)

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 identifier (NCT number): NCT03143296

Layout table for location information
United States, Florida
University of Miami Department of Otolaryngology
Miami, Florida, United States, 33175
Sponsors and Collaborators
University of Miami
Layout table for investigator information
Principal Investigator: Sandra Prentiss, PhD University of Miami

Layout table for additonal information
Responsible Party: Sandra Prentiss, Assistant Professor, University of Miami Identifier: NCT03143296     History of Changes
Other Study ID Numbers: 20170198
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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
Signs and Symptoms