Back to resultsCP1150 Sound Processor Speech Perception Compared With the Next Generation of Signal Processing Technology
Primary Purpose
Hearing Impairment, Sensorineural
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
CP1150 Sound Processor
CP1150 (modified firmware)
CP1150 + FF
CP1110
Sponsored by
About this trial
This is an interventional other trial for Hearing Impairment, Sensorineural
Eligibility Criteria
Inclusion Criteria:
- Aged 18 years or older
- Post lingually deafened
- Implanted with the CI600 Series, CI500 Series or Freedom Series
- At least 6 months experience with a cochlear implant.
- At least 3 months experience with a CP910/920, CP950, CP1150, or CP1000 Sound Processor
- MAP Total Stimulation Rate of 7.2kHz or greater
- Able to score 30% or more with CI alone on a monosyllabic words in quiet test
- Willingness to participate in and to comply with all requirements of the protocol
- Fluent speaker in English as determined by the investigator
- Willing and able to provide written informed consent
Exclusion Criteria:
- Additional disabilities that would prevent participation in evaluations.
- Implant location that would result in undesirable hearing performance or discomfort with an off-the-ear sound processor, as determined by the investigator.
- Unable or unwilling to comply with the requirements of the clinical investigation, as determined by the Investigator.
- Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
- Currently participating or participated in another interventional clinical study/trial in the past 30 days unless (if less than 30 days) the prior investigation was Cochlear sponsored and determined by the investigator to not impact clinical findings of this investigation.
- Implanted with other active implantable medical devices (e.g. pacemaker, defibrillator).
Sites / Locations
- Cochlear Sydney
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
CP1150
CP1150 (modified firmware)
CP1150 + FF
CP1110
Arm Description
CP1150 will be used as the comparator device for speech perception testing in quiet.
CP1150 Sound Processor with modified firmware.
CP1150 Sound Processor with ForwardFocus.
CP1110 is a BTE Sound Processor.
Outcomes
Primary Outcome Measures
Speech perception in quiet using an OTE Sound Processor
Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with modified firmware.
Secondary Outcome Measures
Speech perception in quiet using an OTE Sound Processor using FF combined with standard microphone directionality
Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with FF
Speech perception in quiet with CP1150 and CP1110 Sound Processors
Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1110 Sound Processor
Full Information
NCT ID
NCT05286385
First Posted
February 22, 2022
Last Updated
July 6, 2022
Sponsor
Cochlear
Collaborators
Avania
1. Study Identification
Unique Protocol Identification Number
NCT05286385
Brief Title
CP1150 Sound Processor Speech Perception Compared With the Next Generation of Signal Processing Technology
Official Title
A Pre-Marketing, Prospective, Single-Site, Open-Label, Within-Subject, Pilot, Interventional Study of Adult Cochlear Implant Speech Perception With the CP1150 Sound Processor Compared With the Next Generation of Signal Processing Technology
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
June 29, 2022 (Actual)
Study Completion Date
June 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
Collaborators
Avania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This clinical study aims to investigate speech performance in quiet with an OTE Sound Processor with modified firmware compared with the commercially available CP1150. The study also investigates CP1110 and CP1150 with Forward Focus.
Detailed Description
This study will build on the evidence previously collected on OTE and BTE Sound Processors and will support the design goals for access to the same sound processing algorithms across future OTE and BTE variants, including evidence required on the automation of FF and future implant compatibility.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Impairment, Sensorineural
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CP1150
Arm Type
Active Comparator
Arm Description
CP1150 will be used as the comparator device for speech perception testing in quiet.
Arm Title
CP1150 (modified firmware)
Arm Type
Experimental
Arm Description
CP1150 Sound Processor with modified firmware.
Arm Title
CP1150 + FF
Arm Type
Experimental
Arm Description
CP1150 Sound Processor with ForwardFocus.
Arm Title
CP1110
Arm Type
Experimental
Arm Description
CP1110 is a BTE Sound Processor.
Intervention Type
Device
Intervention Name(s)
CP1150 Sound Processor
Intervention Description
Speech perception tests whilst the subject is fitted with the CP1150 Sound Processor
Intervention Type
Device
Intervention Name(s)
CP1150 (modified firmware)
Intervention Description
Speech perception tests whilst the subject is fitted with the CP1150 modified firmware.
Intervention Type
Device
Intervention Name(s)
CP1150 + FF
Intervention Description
Speech perception tests whilst the subject is fitted with the CP1150 Sound Processor with ForwardFocus.
Intervention Type
Device
Intervention Name(s)
CP1110
Intervention Description
Speech perception tests whilst the subject is fitted with the CP1110 Sound Processor.
Primary Outcome Measure Information:
Title
Speech perception in quiet using an OTE Sound Processor
Description
Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with modified firmware.
Time Frame
One day
Secondary Outcome Measure Information:
Title
Speech perception in quiet using an OTE Sound Processor using FF combined with standard microphone directionality
Description
Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with FF
Time Frame
One day
Title
Speech perception in quiet with CP1150 and CP1110 Sound Processors
Description
Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1110 Sound Processor
Time Frame
One day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18 years or older
Post lingually deafened
Implanted with the CI600 Series, CI500 Series or Freedom Series
At least 6 months experience with a cochlear implant.
At least 3 months experience with a CP910/920, CP950, CP1150, or CP1000 Sound Processor
MAP Total Stimulation Rate of 7.2kHz or greater
Able to score 30% or more with CI alone on a monosyllabic words in quiet test
Willingness to participate in and to comply with all requirements of the protocol
Fluent speaker in English as determined by the investigator
Willing and able to provide written informed consent
Exclusion Criteria:
Additional disabilities that would prevent participation in evaluations.
Implant location that would result in undesirable hearing performance or discomfort with an off-the-ear sound processor, as determined by the investigator.
Unable or unwilling to comply with the requirements of the clinical investigation, as determined by the Investigator.
Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
Currently participating or participated in another interventional clinical study/trial in the past 30 days unless (if less than 30 days) the prior investigation was Cochlear sponsored and determined by the investigator to not impact clinical findings of this investigation.
Implanted with other active implantable medical devices (e.g. pacemaker, defibrillator).
Facility Information:
Facility Name
Cochlear Sydney
City
Macquarie Park
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CP1150 Sound Processor Speech Perception Compared With the Next Generation of Signal Processing Technology
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