Hearing ImpairmentPOLARNCT05619575
Acceptance and Performance of the CP1170 Sound Processor in Experienced Adult Cochlear Implant Recipients
A study testing CP1170 Sound Processor and CP1150 Sound Processor in people with Hearing Impairment, run by Cochlear at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Impairment
- What is being tested?
- CP1170 Sound Processor and CP1150 Sound Processor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 20 Dec 2022to 10 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the detailed description
This investigation is planned to investigate the performance and clinical benefits of features that are new to the CP1170 Sound Processor. This study will build on the evidence previously collected on off-the-ear (OTE) 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.
- Conditions
- Hearing Impairment
- Being tested
- CP1170 Sound Processor, CP1150 Sound Processor
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP1170 Sound ProcessorDevice
The CP1170 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.
CP1150 Sound ProcessorDevice
Active comparator off-the-ear sound processor.
| Study group | Role | What they receive |
|---|---|---|
| CP1170 Sound Processor | Experimental | Take home use of CP1170 Sound Processor for 2 weeks followed by in-booth testing of this investigational device. The SCAN 2 FF (automated ForwardFocus On) program will be compared to the SCAN 2 (ForwardFocus Off) program in the CP1170 Sound Processor. This investigational device will also be compared to the CP1150 Sound Processor and participants' own sound processor. Receives: Device: CP1170 Sound Processor; Device: CP1150 Sound Processor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paired Difference in dB SRT Between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) in 65 dB SPL (Sound Pressure Level) S0Nrearhalf 4Talker Babble (Speech Perception in Noise)
Speech perception in noise was measured using the Australian Speech Test In Noise (AUSTIN), which is a test that uses Bamford-Kowal-Bench (BKB)-like target sentences presented in adaptive noise. The goal of the speech perception test in noise was to provide the speech-to-noise ratio for 50% speech intelligibility.
Measured: During a Single Ad-Hoc Visit (between Day 141 - Day 218)
Secondary outcomes (4)
Paired Difference in dB SRT Between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) in 65 dB SPL S0N3 Babble (Speech Perception in Noise)
Speech perception in noise was measured using the Australian Speech Test In Noise (AUSTIN), which is a test that uses Bamford-Kowal-Bench (BKB)-like target sentences presented in adaptive noise. The goal of the speech perception test in noise was to provide the speech-to-noise ratio for 50% speech intelligibility.
Measured: During a single Ad-Hoc Visit (anytime between Day 141 - Day 218)
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)
Speech perception in quiet was measured using the CNC monosyllabic words at 50 dB SPL from S0 position. The goal of speech perception assessment in quiet was to compare % words correct for each of the conditions.
Measured: During Ad-Hoc Visit (anytime between Day 127 - Day 190)
Subjective Acceptance and Satisfaction Between the CP1170 Sound Processor and the Subject's Own Processor
Number of participants who were somewhat or very satisfied with the overall sound quality of their SCAN program (SCAN in own sound processor, SCAN 2 FF in CP1170) as indicated through two questionnaires. The CP1170 Questionnaire and Baseline Questionnaire have a 5-point Likert scale for each rating (with the values ranging from: 1 = least favourable option to 3 = Neutral to 5 = most favourable option).
Measured: 2 weeks
Paired Difference in Global SSQ12 Scores After Experience With the CP1170 Sound Processor and Own Processor
The SSQ12, which measures subjective hearing performance, is comprised of 12 items using the response format on a scale from 0 to 10, where 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 higher the benefit. A positive score indicates improved hearing, and a negative value indicates impaired hearing.
Measured: During a Single Ad-Hoc Visit (anytime between Day 23 - Day 70)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start20 Dec 2022
- Primary completion7 Sep 2023
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing ImpairmentStudies of the same condition, open and under way.
- More trials run by CochlearThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619575
- Sponsor's protocol ID
- CLTD5836
- Acronym
- POLAR
- Status last verified
- Aug 2025
- First submitted
- 9 Nov 2022
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jones M, Hong W, Schou IM, Mashal ME. Improved Speech Recognition with Automated ForwardFocus in Cochlear Kanso 3 Sound Processor Users. Otol Neurotol Open. 2026 Mar 18;6(1):e087. doi: 10.1097/ONO.0000000000000087. eCollection 2026 Mar.
PubMed 41884522
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05619575
- Acronym / sponsor ID
- POLAR / CLTD5836
- Conditions
- Hearing Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 17 Nov 2022 (actual)
- Results
- Posted 31 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 CP1170 Sound Processor. This study will build on the evidence previously collected on off-the-ear (OTE) 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CP1170 Sound Processor | Experimental | Device: CP1170 Sound Processor, Device: CP1150 Sound ProcessorTake home use of CP1170 Sound Processor for 2 weeks followed by in-booth testing of this investigational device. The SCAN 2 FF (automated ForwardFocus On) program will be compared to the SCAN 2 (ForwardFocus Off) program in the CP1170 Sound Processor. This investigational device will also be compared to the CP1150 Sound Processor and participants' own sound processor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CP1170 Sound ProcessorThe CP1170 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. | Device | CP1170 Sound Processor |
| CP1150 Sound ProcessorActive comparator off-the-ear sound processor. | Device | CP1170 Sound Processor |
Primary outcome
Paired Difference in dB SRT Between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) in 65 dB SPL (Sound Pressure Level) S0Nrearhalf 4Talker Babble (Speech Perception in Noise)
Time frame: During a Single Ad-Hoc Visit (between Day 141 - Day 218)
Speech perception in noise was measured using the Australian Speech Test In Noise (AUSTIN), which is a test that uses Bamford-Kowal-Bench (BKB)-like target sentences presented in adaptive noise. The goal of the speech perception test in noise was to provide the speech-to-noise ratio for 50% speech intelligibility.
4 secondary outcomes
Paired Difference in dB SRT Between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) in 65 dB SPL S0N3 Babble (Speech Perception in Noise)
Time frame: During a single Ad-Hoc Visit (anytime between Day 141 - Day 218)
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: During Ad-Hoc Visit (anytime between Day 127 - Day 190)
Subjective Acceptance and Satisfaction Between the CP1170 Sound Processor and the Subject's Own Processor
Time frame: 2 weeks
Paired Difference in Global SSQ12 Scores After Experience With the CP1170 Sound Processor and Own Processor
Time frame: During a Single Ad-Hoc Visit (anytime between Day 23 - Day 70)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41884522Jones M, Hong W, Schou IM, Mashal ME. Improved Speech Recognition with Automated ForwardFocus in Cochlear Kanso 3 Sound Processor Users. Otol Neurotol Open. 2026 Mar 18;6(1):e087. doi: 10.1097/ONO.0000000000000087. eCollection 2026 Mar.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CP1170 Sound Processor and CP1150 Sound Processor in people with Hearing Impairment, run by Cochlear at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paired Difference in dB SRT Between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) in 65 dB SPL (Sound Pressure Level) S0Nrearhalf 4Talker Babble (Speech Perception in Noise) (time frame: During a Single Ad-Hoc Visit (between Day 141 - Day 218)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05619575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.