Reverberation Effects on MED-EL Recipients
The Effects of Reverberation on Speech Understanding in MED-EL Cochlear Implant Recipients
1 other identifier
interventional
10
1 country
1
Brief Summary
The purpose of this study is to investigate speech understanding in simulated reverberant environments with MED-EL cochlear implant recipients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2017
CompletedFirst Posted
Study publicly available on registry
May 8, 2017
CompletedStudy Start
First participant enrolled
August 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 16, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 16, 2021
CompletedAugust 26, 2021
August 1, 2021
2.7 years
April 26, 2017
August 25, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Speech Performance
Speech performance recorded as percent correct compared to different electrode lengths.
Up to six months
Coding strategy
Speech scores, in percent correct, recorded from simulated reverberant speech tests will be compared between fine structure and envelope coding strategies.
Two hours
Study Arms (2)
Current recipient of a Med-El cochlear implant
EXPERIMENTALParticipants 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.
Future Med-El Recipient
ACTIVE COMPARATORCochlear 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.
Interventions
Reverberant environments simulate real-life situations mimicking a living room, classroom and auditorium. Each simulation lasts up to 2 hours.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- Med-El Corporationcollaborator
Study Sites (1)
University of Miami Department of Otolaryngology
Miami, Florida, 33175, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandra Prentiss, PhD
University of Miami
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 26, 2017
First Posted
May 8, 2017
Study Start
August 16, 2018
Primary Completion
April 16, 2021
Study Completion
April 16, 2021
Last Updated
August 26, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share