Evaluation of Subjective Ratings on a New Sound Processor and Compatible Products

November 15, 2016 updated by: Cochlear
Clinical study designed to collect user feedback from Cochlear Implant recipients on a new Sound Processor System

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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

  • Belgium
    • Wilrijk
      • Antwerp, Wilrijk, Belgium, 2610
        • Sint-Augustinus Antwerpen
  • United Kingdom
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO17 1BJ
        • University of Southampton - Auditory Implant Service Highfield
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Nottingham University Hospitals - Queens Medical Centre

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

1 year to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 12 months old or older
  2. Implanted with a CI24RE (Freedom implant) or later implant in at least one implanted ear
  3. Use of the CP810, CP920 or CP910 sound processor
  4. Willingness to participate in and to comply with all requirements of the protocol

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 or illnesses that would prevent participation in evaluations or compromise the integrity of the investigation or quality of data collected
  3. Nucleus 22 or Nucleus 24 Implant in ear to be fitted with the investigational device

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A New Sound Processor
Sound Processor is the next generation sound processor.
Device: A New Sound Processor
No Intervention: Subject's own sound processor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Subjective rating with a new sound processor compared to ratings with each subjects own processor
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Cochlear

Investigators

  • Study Chair: Mary Beth Brinson, Head of clinical affairs

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

Primary Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

October 13, 2016

First Submitted That Met QC Criteria

October 13, 2016

First Posted (Estimate)

October 17, 2016

Study Record Updates

Last Update Posted (Estimate)

November 17, 2016

Last Update Submitted That Met QC Criteria

November 15, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLTD5665

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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