Usability of the CP950 Sound Processor (C950)

August 14, 2018 updated by: Cochlear

Usability of the CP950 Sound Processor With Experienced Cochlear Implant Users

Studying usability and gaining feedback of the CP950 Sound Processor in experienced cochlear implant recipients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One month protocol, with 2 study visits. The aim of the study to is to gain patient and audiologist feedback on their experience and usability with the device and wireless programming pod.

Study Type

Interventional

Enrollment (Actual)

30

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

  • United States
    • Colorado
      • Englewood, Colorado, United States, 80013
        • Rocky Mountain Ear Center
    • New York
      • New York, New York, United States, 10523
        • NYU
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Hearts for Hearing

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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear
  2. Subjects age 12 and older who are cognitively and developmentally able to complete all study related questionnaires as deemed by the principal investigator or delegated staff
  3. At least 3 months experience with the CP810,CP920 or CP910 sound processor
  4. Ability to use 2 zinc air batteries with their current program (MAP)
  5. Willingness to participate in and to comply with all requirements of the protocol for the duration of the trial

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. Implant types not currently supported by the CP950 sound processor (i.e.,N22)

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: Treatment group
All patients will receive the CP950 Sound Processor and be part of the treatment group for one month which is programmed via the wireless programming pod
Device: CP950 Sound Processor
An off-the-ear processor configuration with identical functionality to the commercially approved CP910/920 processor
Device: Wireless programming pod
The CP950 Sound Processor will be programmed by the wireless programming pod, which is needed as the interface to commercially approved programming software

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire
Time Frame: 1 month

To evaluate usability of the CP950 sound processor using the CP950 Take Home Questionnaire for existing cochlear implant users.

Specifically:

  1. Patient Reported Hearing Performance
  2. Retention & Comfort
  3. Ease of use
  4. Use of remote controls
  5. Look & feel
  6. Reliability
  7. Maintenance & use
1 month

Collaborators and Investigators

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

Sponsor

Cochlear

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)

April 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

April 4, 2016

First Posted (Estimate)

April 5, 2016

Study Record Updates

Last Update Posted (Actual)

September 12, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAM5657

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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