Back to resultsN6 Input Processing in Traditional CI Recipients
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nucleus 6 Sound Processor
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- Greater than 12 years
- Unilateral cochlear implant recipient (CI24RE, CI500, CI422)
- Minimum of 3 months experience with the N5 sound processor
- Prior documentation of sentence recognition testing in noise at a difficulty of +10 dB SNR or better
- Native English speaker
- Willingness to participate in and comply with all requirements of the protocol
Exclusion Criteria:
- Unrealistic expectations
- Unwillingness to comply with investigational requirements of the protocol
- Additional handicaps that would prevent or restrict participation in the evaluations
Sites / Locations
- Rocky Mountain Ear Center
- Center for Hearing and Balance
- Hospital of the University of Pennsylvania
- Houston Ear Research Foundation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
N6 Input Processing Features
Arm Description
Outcomes
Primary Outcome Measures
Endpoint 1: Evaluation of Signal to Noise Ratio - Noise Reduction
Speech understanding in noise using AzBio sentences with and without the SNR - noise reduction algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off.
Endpoint 2: Evaluation of SCAN
Speech understanding in noise using AzBio sentences with and without SCAN algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02239263
Brief Title
N6 Input Processing in Traditional CI Recipients
Official Title
Investigation of Nucleus 6 Sound Processor Input Processing in Cochlear Implant Recipients.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
January 2015 (Actual)
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
The purpose of this study is to evaluate the enhanced signal processing features of the Nucleus 6 Sound Processor on existing Nucleus cochlear implant recipients currently using the Nucleus 5 Sound Processor.
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
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N6 Input Processing Features
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Nucleus 6 Sound Processor
Primary Outcome Measure Information:
Title
Endpoint 1: Evaluation of Signal to Noise Ratio - Noise Reduction
Description
Speech understanding in noise using AzBio sentences with and without the SNR - noise reduction algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off.
Time Frame
Visit 2, 1 month after baseline testing
Title
Endpoint 2: Evaluation of SCAN
Description
Speech understanding in noise using AzBio sentences with and without SCAN algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off.
Time Frame
Visit 2, 1 month after baseline testing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Greater than 12 years
Unilateral cochlear implant recipient (CI24RE, CI500, CI422)
Minimum of 3 months experience with the N5 sound processor
Prior documentation of sentence recognition testing in noise at a difficulty of +10 dB SNR or better
Native English speaker
Willingness to participate in and comply with all requirements of the protocol
Exclusion Criteria:
Unrealistic expectations
Unwillingness to comply with investigational requirements of the protocol
Additional handicaps that would prevent or restrict participation in the evaluations
Facility Information:
Facility Name
Rocky Mountain Ear Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Center for Hearing and Balance
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Houston Ear Research Foundation
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
12. IPD Sharing Statement
Learn more about this trial
N6 Input Processing in Traditional CI Recipients
We'll reach out to this number within 24 hrs