Reverberation Effects on MED-EL Recipients

Not Applicable

Completed

• Conditions: Hearing Loss, Sensorineural
• Interventions: Other: Simulated reverberant environment

• Registration Number: NCT03143296
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-08
• Study Start: 2018-08-16
• Primary Completion: 2021-04-16
• Study Completion: 2021-04-16
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Future Med-El Recipient	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.
Current recipient of a Med-El cochlear implant	Simulated reverberant environment	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.

Primary Outcome Measures

Name	Time	Method
Coding strategy	Two hours	Speech scores, in percent correct, recorded from simulated reverberant speech tests will be compared between fine structure and envelope coding strategies.
Speech Performance	Up to six months	Speech performance recorded as percent correct compared to different electrode lengths.

Trial Locations

Locations (1)

University of Miami Department of Otolaryngology; 🇺🇸 Miami, Florida, United States