search
Back to results

Usability of the CP950 Sound Processor (C950)

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CP950 Sound Processor
Wireless programming pod
Sponsored by
Cochlear
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring cochlear implant, Sound Processor

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Rocky Mountain Ear Center
  • NYU
  • Hearts for Hearing

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

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

Outcomes

Primary Outcome Measures

Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire
To evaluate usability of the CP950 sound processor using the CP950 Take Home Questionnaire for existing cochlear implant users. Specifically: Patient Reported Hearing Performance Retention & Comfort Ease of use Use of remote controls Look & feel Reliability Maintenance & use

Secondary Outcome Measures

Full Information

First Posted
March 17, 2016
Last Updated
August 14, 2018
Sponsor
Cochlear
search

1. Study Identification

Unique Protocol Identification Number
NCT02727842
Brief Title
Usability of the CP950 Sound Processor
Acronym
C950
Official Title
Usability of the CP950 Sound Processor With Experienced Cochlear Implant Users
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
cochlear implant, Sound Processor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
CP950 Sound Processor
Intervention Description
An off-the-ear processor configuration with identical functionality to the commercially approved CP910/920 processor
Intervention Type
Device
Intervention Name(s)
Wireless programming pod
Intervention Description
The CP950 Sound Processor will be programmed by the wireless programming pod, which is needed as the interface to commercially approved programming software
Primary Outcome Measure Information:
Title
Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire
Description
To evaluate usability of the CP950 sound processor using the CP950 Take Home Questionnaire for existing cochlear implant users. Specifically: Patient Reported Hearing Performance Retention & Comfort Ease of use Use of remote controls Look & feel Reliability Maintenance & use
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear 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 At least 3 months experience with the CP810,CP920 or CP910 sound processor Ability to use 2 zinc air batteries with their current program (MAP) Willingness to participate in and to comply with all requirements of the protocol for the duration of the trial Exclusion criteria: Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device Additional disabilities that would prevent participation in evaluations Implant types not currently supported by the CP950 sound processor (i.e.,N22)
Facility Information:
Facility Name
Rocky Mountain Ear Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80013
Country
United States
Facility Name
NYU
City
New York
State/Province
New York
ZIP/Postal Code
10523
Country
United States
Facility Name
Hearts for Hearing
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Usability of the CP950 Sound Processor

We'll reach out to this number within 24 hrs