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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03143296
Other study ID # 20170198
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 16, 2018
Est. completion date April 16, 2021

Study information

Verified date August 2021
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

The study will determine if electrode length and coding strategy effect performance. The investigator will also study performance over time with new recipients.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date April 16, 2021
Est. primary completion date April 16, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Simulated reverberant environment
Reverberant environments simulate real-life situations mimicking a living room, classroom and auditorium. Each simulation lasts up to 2 hours.

Locations

Country Name City State
United States University of Miami Department of Otolaryngology Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Miami Med-El Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Speech Performance Speech performance recorded as percent correct compared to different electrode lengths. Up to six months
Primary 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
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