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Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy

NCT01337076 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2016-10-27

Study results available
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Summary

The Sponsor values the progression of hearing healthcare practice and acknowledges a need for re-evaluation of indications for determining adult cochlear implant candidacy. This need arises from current research, peer reviewed literature, and technological advancement with concomitant performance outcomes. To address this specifically, the Sponsor proposes to evaluate the safety and efficacy of the Cochlear™ Nucleus® implant system with a revised indication.

Conditions

Interventions

DEVICE

cochlear implant

Cochlear implant surgery

Sponsors & Collaborators

  • Cochlear

    lead INDUSTRY

Principal Investigators

  • Colin Driscoll, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01337076 on ClinicalTrials.gov