Clinical Evaluation of a Cochlear Implant System

NCT ID: NCT03467399

Last Updated: 2018-03-16

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

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2017-09-07

Brief Summary

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The primary objective of this study is to assess the usability of a Cochlear implant system.

Detailed Description

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Measure participant ratings on satisfaction of a Cochlear implant system via use of validated and non-validated questionnaires.

Conditions

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Sensorineural 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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Cochlear implant users

This is a within-subject, repeated measures study. There was one arm in this study, each subject served as their own control. All subjects received all interventions.

Group Type EXPERIMENTAL

Nucleus 7 Cochlear Implant System

Intervention Type DEVICE

A new cochlear implant sound processor system.

Interventions

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Nucleus 7 Cochlear Implant System

A new cochlear implant sound processor system.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Eighteen years of age or older
2. At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear
3. At least 3 months experience with the CP810,CP920 or CP910 sound processor
4. Fluent speaker in the language used to assess speech perception performance
5. Willingness to participate in and to comply with all requirements of the protocol
6. Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test

Exclusion Criteria

1. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device
2. Additional disabilities that would prevent participation in evaluations
3. Nucleus 22 Implant
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cochlear

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary Beth Brinson

Role: PRINCIPAL_INVESTIGATOR

Cochlear Ltd

Locations

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Cochlear Ltd

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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CLTD5620

Identifier Type: -

Identifier Source: org_study_id

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