Cochlear Implantation for Treatment of Single-sided Deafness

NCT02532972 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-05-05

Study results available
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Summary

This is a research study to determine whether a cochlear implantation (CI) device can improve hearing in people who are deaf in one ear (known as single-sided deafness).

Conditions

  • Total Unilateral Deafness
  • Unilateral Partial Deafness

Interventions

DEVICE

Med-el MAESTRO Cochlear Implant with Flex 28 electrode array

Cochlear Implant (CI) surgery followed by device activation, testing, and clinical assessment for 12 months following surgery.

Sponsors & Collaborators

  • University of Wisconsin, Madison

    collaborator OTHER
  • Dr. Daniel Lee

    lead OTHER

Principal Investigators

  • Daniel J Lee, MD, FACS · MEEI / MGH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-02-27
Completion
2019-04-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02532972 on ClinicalTrials.gov