Reverberation Effects on MED-EL Recipients

NCT ID: NCT03143296

Last Updated: 2021-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-16

Study Completion Date

2021-04-16

Brief Summary

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

Detailed Description

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

Conditions

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Hearing Loss, Sensorineural

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Current recipient of a Med-El cochlear implant

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.

Group Type EXPERIMENTAL

Simulated reverberant environment

Intervention Type OTHER

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

Future Med-El Recipient

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.

Group Type ACTIVE_COMPARATOR

Simulated reverberant environment

Intervention Type OTHER

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

Interventions

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Simulated reverberant environment

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Med-El Corporation

INDUSTRY

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Sandra Prentiss

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sandra Prentiss, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami Department of Otolaryngology

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20170198

Identifier Type: -

Identifier Source: org_study_id

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