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Acceptance and Performance of the CP1170 Sound Processor in Experienced Adult Cochlear Implant Recipients (POLAR) (POLAR)

Primary Purpose

Hearing Impairment

Status
Active
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
CP1170 sound processor
CP1150 Sound processor
Sponsored by
Cochlear
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hearing Impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged 18 years or older Post lingually deafened Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522); Freedom Series (CI24RE(CA), CI24RE(ST), CI422) or N24 Series (CIC3). At least 6 months experience with a cochlear hearing implant At least 3 months experience with any Nucleus sound processor and SCAN program Able to score 30% or more at +15 SNR with CI alone on a sentence in babble 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 Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures 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, as determined by the Investigator. Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).

Sites / Locations

  • Cochlear Macquarie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CP1170 sound processor

CP1150 sound processor

Arm Description

Take home use of CP1170 Sound processor for 2 weeks followed by in booth testing of the investigational device.

In booth testing of CP1150 sound processor.

Outcomes

Primary Outcome Measures

Speech perception testing - Speech in Noise using CP1170 sound processor using FF (forwardfocus)
Paired difference in dB SRT between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) (65 dB SPL (sound pressure level) S0Nrearhalf 4Talker Babble).

Secondary Outcome Measures

Speech perception testing - Speech in Noise using CP1170 sound processor using FF (forwardfocus)
Paired difference in dB SRT between the CP1170 SCAN 2 FF (ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF), (65 dB SPL S0N3 Babble).
Speech perception in quiet with CP1170 and CP1150 Sound Processors
Paired difference in percentage CNC (consonant-nucleus-consonant) Words correct in quiet (50 dB) between the CP1170 sound processor and CP1150 sound processor (commercial version)
Subjective acceptance and satisfaction between the CP1170 sound processor and the subject's own processor.
Ratings based on the CP1170 Questionnaire after a minimum 2-weeks actual-use of the CP1170 sound processor in the home environment and the subject's own processor. The CP1170 Questionnaire has a 5-point Likert scale for each rating in the questionnaire for at home usage ( with the values ranging from) : 1 = least favourable option to 3 = Neutral to 5 = most favourable option.
Subjective hearing performance between the CP1170 sound processor and the subject's own processor
Paired difference in Global SSQ12 scores after experience with the CP1170 sound processor and own processor. The SSQ-12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item. The change from baseline is then calculated and the theoretical score could vary between -10 to +10. The higher the score the better benefit and positive score indicates improved hearing, a negative value an impaired hearing.

Full Information

First Posted
November 9, 2022
Last Updated
April 18, 2023
Sponsor
Cochlear
Collaborators
Avania
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1. Study Identification

Unique Protocol Identification Number
NCT05619575
Brief Title
Acceptance and Performance of the CP1170 Sound Processor in Experienced Adult Cochlear Implant Recipients (POLAR)
Acronym
POLAR
Official Title
A Pre-market, Open-label, Within Subject Study, of Acceptance and Performance of the CP1170 Sound Processor in Experienced Adult Cochlear Implant Recipients Compared With the CP1150 Sound Processor and Their Current Sound Processor.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

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
Acceptance and performance of the CP1170 sound processor in experienced adult cochlear implant recipients compared with the CP1150 sound processor and their current sound processor.
Detailed Description
This investigation is planned to investigate the performance and clinical benefits of features that are new to the CP 1170 Sound Processor. This study will build on the evidence previously collected on OTE (off the ear) sound processors and ForwardFocus, with particular focus on the acceptance and satisfaction of the automation of ForwardFocus in the CP1170 Sound Processor and associated components in general.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Impairment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CP1170 sound processor
Arm Type
Experimental
Arm Description
Take home use of CP1170 Sound processor for 2 weeks followed by in booth testing of the investigational device.
Arm Title
CP1150 sound processor
Arm Type
Active Comparator
Arm Description
In booth testing of CP1150 sound processor.
Intervention Type
Device
Intervention Name(s)
CP1170 sound processor
Intervention Description
The CP 1170 sound processor will be used to determine the hearing performance with the new implementation of ForwardFocus in SCAN 2 (SCAN 2 FF), as assessed by speech perception in noise.
Intervention Type
Device
Intervention Name(s)
CP1150 Sound processor
Intervention Description
Active comparator off the ear sound processor.
Primary Outcome Measure Information:
Title
Speech perception testing - Speech in Noise using CP1170 sound processor using FF (forwardfocus)
Description
Paired difference in dB SRT between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) (65 dB SPL (sound pressure level) S0Nrearhalf 4Talker Babble).
Time Frame
One day (in booth testing)
Secondary Outcome Measure Information:
Title
Speech perception testing - Speech in Noise using CP1170 sound processor using FF (forwardfocus)
Description
Paired difference in dB SRT between the CP1170 SCAN 2 FF (ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF), (65 dB SPL S0N3 Babble).
Time Frame
One day (in booth testing)
Title
Speech perception in quiet with CP1170 and CP1150 Sound Processors
Description
Paired difference in percentage CNC (consonant-nucleus-consonant) Words correct in quiet (50 dB) between the CP1170 sound processor and CP1150 sound processor (commercial version)
Time Frame
One day (in booth testing)
Title
Subjective acceptance and satisfaction between the CP1170 sound processor and the subject's own processor.
Description
Ratings based on the CP1170 Questionnaire after a minimum 2-weeks actual-use of the CP1170 sound processor in the home environment and the subject's own processor. The CP1170 Questionnaire has a 5-point Likert scale for each rating in the questionnaire for at home usage ( with the values ranging from) : 1 = least favourable option to 3 = Neutral to 5 = most favourable option.
Time Frame
2 weeks
Title
Subjective hearing performance between the CP1170 sound processor and the subject's own processor
Description
Paired difference in Global SSQ12 scores after experience with the CP1170 sound processor and own processor. The SSQ-12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item. The change from baseline is then calculated and the theoretical score could vary between -10 to +10. The higher the score the better benefit and positive score indicates improved hearing, a negative value an impaired hearing.
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 (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522); Freedom Series (CI24RE(CA), CI24RE(ST), CI422) or N24 Series (CIC3). At least 6 months experience with a cochlear hearing implant At least 3 months experience with any Nucleus sound processor and SCAN program Able to score 30% or more at +15 SNR with CI alone on a sentence in babble 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 Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures 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, as determined by the Investigator. Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).
Facility Information:
Facility Name
Cochlear Macquarie
City
Macquarie
State/Province
Sydney
ZIP/Postal Code
2109
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Acceptance and Performance of the CP1170 Sound Processor in Experienced Adult Cochlear Implant Recipients (POLAR)

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