Back to resultsReverberation Effects on MED-EL Recipients
Primary Purpose
Hearing Loss, Sensorineural
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Simulated reverberant environment
Sponsored by
About this trial
This is an interventional other trial for Hearing Loss, Sensorineural
Eligibility Criteria
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)
Sites / Locations
- University of Miami Department of Otolaryngology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Current recipient of a Med-El cochlear implant
Future Med-El Recipient
Arm Description
Participants who have received a MED-EL cochlear implant as a standard of care for treatment of hearing loss. Participants are tested at one time point with a simulated reverberant environment.
Cochlear implant candidates not yet implanted and chose Med-El device as standard of care for treatment of hearing loss. Participants are tested at 3 time points over 6 months in a simulated reverberant environment.
Outcomes
Primary Outcome Measures
Speech Performance
Speech performance recorded as percent correct compared to different electrode lengths.
Coding strategy
Speech scores, in percent correct, recorded from simulated reverberant speech tests will be compared between fine structure and envelope coding strategies.
Secondary Outcome Measures
Full Information
NCT ID
NCT03143296
First Posted
April 26, 2017
Last Updated
August 25, 2021
Sponsor
University of Miami
Collaborators
Med-El Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03143296
Brief Title
Reverberation Effects on MED-EL Recipients
Official Title
The Effects of Reverberation on Speech Understanding in MED-EL Cochlear Implant Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 16, 2018 (Actual)
Primary Completion Date
April 16, 2021 (Actual)
Study Completion Date
April 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Med-El Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate speech understanding in simulated reverberant environments with MED-EL cochlear implant recipients.
Detailed Description
The study will determine if electrode length and coding strategy effect performance. The investigator will also study performance over time with new recipients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Current recipient of a Med-El cochlear implant
Arm Type
Experimental
Arm Description
Participants who have received a MED-EL cochlear implant as a standard of care for treatment of hearing loss. Participants are tested at one time point with a simulated reverberant environment.
Arm Title
Future Med-El Recipient
Arm Type
Active Comparator
Arm Description
Cochlear implant candidates not yet implanted and chose Med-El device as standard of care for treatment of hearing loss. Participants are tested at 3 time points over 6 months in a simulated reverberant environment.
Intervention Type
Other
Intervention Name(s)
Simulated reverberant environment
Intervention Description
Reverberant environments simulate real-life situations mimicking a living room, classroom and auditorium. Each simulation lasts up to 2 hours.
Primary Outcome Measure Information:
Title
Speech Performance
Description
Speech performance recorded as percent correct compared to different electrode lengths.
Time Frame
Up to six months
Title
Coding strategy
Description
Speech scores, in percent correct, recorded from simulated reverberant speech tests will be compared between fine structure and envelope coding strategies.
Time Frame
Two hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Prentiss, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Department of Otolaryngology
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Reverberation Effects on MED-EL Recipients
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