Back to resultsEvaluation of Subjective Ratings on a New Sound Processor and Compatible Products
Primary Purpose
Hearing Loss
Status
Withdrawn
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
A New Sound Processor
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- 12 months old or older
- Implanted with a CI24RE (Freedom implant) or later implant in at least one implanted ear
- Use of the CP810, CP920 or CP910 sound processor
- Willingness to participate in and to comply with all requirements of the protocol
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 or illnesses that would prevent participation in evaluations or compromise the integrity of the investigation or quality of data collected
- Nucleus 22 or Nucleus 24 Implant in ear to be fitted with the investigational device
Sites / Locations
- SINT-Augustinus Antwerpen
- University of Southampton - Auditory Implant Service Highfield
- Nottingham University Hospitals - Queens Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
A New Sound Processor
Subject's own sound processor
Arm Description
Sound Processor is the next generation sound processor.
Outcomes
Primary Outcome Measures
Subjective rating with a new sound processor compared to ratings with each subjects own processor
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02934373
Brief Title
Evaluation of Subjective Ratings on a New Sound Processor and Compatible Products
Official Title
Evaluation of Subjective Ratings on a New Sound Processor and Compatible Products
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Clinical study designed to collect user feedback from Cochlear Implant recipients on a new Sound Processor System
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A New Sound Processor
Arm Type
Active Comparator
Arm Description
Sound Processor is the next generation sound processor.
Arm Title
Subject's own sound processor
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
A New Sound Processor
Primary Outcome Measure Information:
Title
Subjective rating with a new sound processor compared to ratings with each subjects own processor
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
12 months old or older
Implanted with a CI24RE (Freedom implant) or later implant in at least one implanted ear
Use of the CP810, CP920 or CP910 sound processor
Willingness to participate in and to comply with all requirements of the protocol
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 or illnesses that would prevent participation in evaluations or compromise the integrity of the investigation or quality of data collected
Nucleus 22 or Nucleus 24 Implant in ear to be fitted with the investigational device
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Beth Brinson
Organizational Affiliation
Head of Clinical Affairs
Official's Role
Study Chair
Facility Information:
Facility Name
SINT-Augustinus Antwerpen
City
Antwerp
State/Province
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
University of Southampton - Auditory Implant Service Highfield
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO17 1BJ
Country
United Kingdom
Facility Name
Nottingham University Hospitals - Queens Medical Centre
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of Subjective Ratings on a New Sound Processor and Compatible Products
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