Back to resultsAcceptance of the CP950 Sound Processor
Primary Purpose
Hearing Loss, Sensorineural
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CP950 OTE Sound processor
Sponsored by
About this trial
This is an interventional other trial for Hearing Loss, Sensorineural
Eligibility Criteria
Inclusion Criteria:
- Eighteen years of age or older
- At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear
- At least 3 months experience with the CP810,CP920 or CP910 sound processor
- Native speaker in the language used to assess speech perception performance
- Willingness to participate in and to comply with all requirements of the protocol
- Able to score 30% or more at +15 SNR with CI alone
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
- Nucleus 22 Implant
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All participants
Arm Description
At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear and at least 3 months experience with the CP810,CP920 or CP910 sound processor.
Outcomes
Primary Outcome Measures
Acceptability Ratings for the CP950 Sound Processor Compared to Subjects' Own Processors, Summarized by the Overall Hearing Performance Score.
Each subject used the Investigational device (CP950) for take home use to obtain subjective ratings.
During the take home use, A subjective questionnaire was asked them to recall and rate how their hearing performance with the Investigational device CP950 OTE processor compared to their hearing performance with their own CP810, CP910 or CP920 BTE processor.
Likert scale was used for each rating in the questionnaire for at home usage ( with the values ranging from) : 1 = much worse; 2 = somewhat worse; 3 = No difference; 4 = somewhat better; 5 = much better.
Secondary Outcome Measures
Speech Reception Threshold (SNR50) for Sentence Testing in Noise With CP950 Sound Processor .
Signal to noise ratio (measured in decibels) providing 50% speech intelligibility for sentences presented in noise to evaluate the benefit from microphone directionality with the CP950 OTE (Off the ear) sound processor.
Percentage of Correct Words Scored With Sentences in Noise With the CP950 Sound Processor
Two lists of twenty sentences presented from front speaker with 4 Talker babble noise presented from rear-half speakers. Higher the percentage of correct words means better outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03613909
Brief Title
Acceptance of the CP950 Sound Processor
Official Title
Acceptance of the CP950 Sound Processor With Experienced CP810/CP910/CP920 BTE Sound Processor Users
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (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
Acceptance of CP950 sound processor with experienced CP810/CP910/CP920 BTE sound processor users.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Repeated measures, single-subject experiment. Each subject received the same treatment.
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All participants
Arm Type
Experimental
Arm Description
At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear and at least 3 months experience with the CP810,CP920 or CP910 sound processor.
Intervention Type
Device
Intervention Name(s)
CP950 OTE Sound processor
Intervention Description
CP950 is Off The Ear (OTE) Cochlear Implant Sound Processor
Primary Outcome Measure Information:
Title
Acceptability Ratings for the CP950 Sound Processor Compared to Subjects' Own Processors, Summarized by the Overall Hearing Performance Score.
Description
Each subject used the Investigational device (CP950) for take home use to obtain subjective ratings.
During the take home use, A subjective questionnaire was asked them to recall and rate how their hearing performance with the Investigational device CP950 OTE processor compared to their hearing performance with their own CP810, CP910 or CP920 BTE processor.
Likert scale was used for each rating in the questionnaire for at home usage ( with the values ranging from) : 1 = much worse; 2 = somewhat worse; 3 = No difference; 4 = somewhat better; 5 = much better.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Speech Reception Threshold (SNR50) for Sentence Testing in Noise With CP950 Sound Processor .
Description
Signal to noise ratio (measured in decibels) providing 50% speech intelligibility for sentences presented in noise to evaluate the benefit from microphone directionality with the CP950 OTE (Off the ear) sound processor.
Time Frame
in booth testing 1 day.
Title
Percentage of Correct Words Scored With Sentences in Noise With the CP950 Sound Processor
Description
Two lists of twenty sentences presented from front speaker with 4 Talker babble noise presented from rear-half speakers. Higher the percentage of correct words means better outcome.
Time Frame
In booth testing 1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eighteen years of age or older
At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear
At least 3 months experience with the CP810,CP920 or CP910 sound processor
Native speaker in the language used to assess speech perception performance
Willingness to participate in and to comply with all requirements of the protocol
Able to score 30% or more at +15 SNR with CI alone
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
Nucleus 22 Implant
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acceptance of the CP950 Sound Processor
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