Single-Sided Deafness and Asymmetric Hearing Loss

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Med-El Corporation
Study ID
NCT04506853
Status
Recruiting
Apply to this trial

Conditions

  • Hearing Loss, Sensorineural
  • Hearing Loss, Unilateral

Eligibility Criteria

Sex
ALL
Age
5 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MED-EL Cochlear Implant System — DEVICE
    Cochlear implant and audio processor

Study Details

The purpose of the study is to evaluate the long-term safety and effectiveness of cochlear implantation of the approved population in adults and children with single-sided deafness and asymmetric hearing loss.

Key Dates

Start date
Feb 22, 2021
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
65 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Study Procedure

Primary Outcome Measure

Long-term performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through three years (36 months) post implantation [ Time Frame: Three years (36 months) post implantation ]

Locations (5)

FacilityCityStateZIPSite coordinators
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611-
University of IowaIowa CityIowa52242-1078
Camille Dunn, PhD
[email protected]
319-353-8776
Camille Dunn, PhD (PRINCIPAL_INVESTIGATOR)
New York Eye and Ear InfirmaryNew YorkNew York10003
Samantha Udondem, MPH
[email protected]
347-978-3973
Maura Cosetti, MD (PRINCIPAL_INVESTIGATOR)
University of North CarolinaChapel HillNorth Carolina27517-
Virginia Mason Medical CenterSeattleWashington98101
Kelly Robertson
[email protected]
206-287-6263
Daniel Zietler, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
Ann & Robert H. Lurie Children's Hospital of Chicago· Chicago, ILUniversity of Iowa· Iowa City, IANew York Eye and Ear Infirmary· New York, NYUniversity of North Carolina· Chapel Hill, NCVirginia Mason Medical Center· Seattle, WA

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