N6 Input Processing in Traditional CI Recipients

NCT ID: NCT02239263

Last Updated: 2021-02-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-01-31

Brief Summary

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The purpose of this study is to evaluate the enhanced signal processing features of the Nucleus 6 Sound Processor on existing Nucleus cochlear implant recipients currently using the Nucleus 5 Sound Processor.

Detailed Description

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Conditions

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Hearing Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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N6 Input Processing Features

Group Type EXPERIMENTAL

Nucleus 6 Sound Processor

Intervention Type DEVICE

Interventions

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Nucleus 6 Sound Processor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Greater than 12 years
* Unilateral cochlear implant recipient (CI24RE, CI500, CI422)
* Minimum of 3 months experience with the N5 sound processor
* Prior documentation of sentence recognition testing in noise at a difficulty of +10 dB SNR or better
* Native English speaker
* Willingness to participate in and comply with all requirements of the protocol

Exclusion Criteria

* Unrealistic expectations
* Unwillingness to comply with investigational requirements of the protocol
* Additional handicaps that would prevent or restrict participation in the evaluations
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cochlear

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rocky Mountain Ear Center

Englewood, Colorado, United States

Site Status

Center for Hearing and Balance

Chesterfield, Missouri, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Houston Ear Research Foundation

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CAM5555

Identifier Type: -

Identifier Source: org_study_id

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