Clinical Evaluation of a Cochlear Implant System

March 9, 2018 updated by: Cochlear
The primary objective of this study is to assess the usability of a Cochlear implant system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2109
        • Cochlear Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Nucleus 7 Cochlear Implant System
A new cochlear implant sound processor system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cochlear implant subjects' ratings on hearing performance, connectivity, streaming, phone use, comfort, retention, ease of use and controls obtained with their own Sound Processor and the CP1000 Sound Processor.
Time Frame: One year
Non-inferiority of subjects' overall satisfaction ratings for the CP1000 Sound Processor and related components measured following 3 months of use, compared to subjects' overall satisfaction rating for their own Sound Processor and related components measured at study onset.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech perception performance of the CP1000 Sound Processor in quiet and in noise.
Time Frame: One year
Data to substantiate the speech perception scores of the subjects for different quiet and noise conditions for different configurations of sound processor and / or accessories.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cochlear

Investigators

  • Principal Investigator: Mary Beth Brinson, Cochlear Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

September 7, 2017

Study Completion (Actual)

September 7, 2017

Study Registration Dates

First Submitted

September 16, 2016

First Submitted That Met QC Criteria

March 9, 2018

First Posted (Actual)

March 16, 2018

Study Record Updates

Last Update Posted (Actual)

March 16, 2018

Last Update Submitted That Met QC Criteria

March 9, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLTD5620

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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