Adult Cochlear Implant RecipientsPINNANCT05080283

Acceptance and Performance of CP1110 Sound Processor With Experienced Adult Cochlear Implant Recipients.

A study testing CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF), Nucleus 7 Sound Processor (model: CP1000) system and CP1110 Sound Processor System with ForwardFocus Off (SCAN 2) in people with Adult Cochlear Implant Recipients, run by Cochlear at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Adult Cochlear Implant Recipients
What is being tested?: CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF), Nucleus 7 Sound Processor (model: CP1000) system and CP1110 Sound Processor System with ForwardFocus Off (SCAN 2)
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: 2 Nov 2021to 13 Sep 2022
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
Healthy volunteers accepted
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) or Freedom Series (CI24RE(CA), CI24RE(ST), CI422).
At least 6 months experience with a cochlear implant.
At least 3 months experience with a Nucleus 7 (CP1000) Sound Processor
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.
Currently participating, or participated in another interventional clinical study/trial in the past 30 days or if less than 30 days, the prior investigation was Cochlear sponsored and determined by the investigator to not impact clinical findings of this investigation.

Trial locations and contacts

1 site in 1 country.

Australia1 site

Cochlear Sydney
Sydney, New South Wales, 2109

Other trials in Australia

About this study

Official title: A Pre-Marketing, Prospective, Single-Site, Open-Label, Within-Subject, Actual-Use, Interventional Study of Acceptance and Performance With Experienced Adult Cochlear Implant Recipients Using the CP1110 Sound Processor Compared With the CP1000 Sound Processor

Read the detailed description

The clinical study aims to investigate acceptance, actual-use usability and speech performance with a new behind-the-ear sound processor (model number: CP1110) system, compared with the commercially available Nucleus 7 Sound Processor (model: CP1000) system, with particular focus on the acceptance of and satisfaction with a noise reduction feature in the Automatic Scene Classifier 'SCAN 2'. This study will build on the evidence collected in previous Nucleus 7 Sound Processor take home studies and will also aim to confirm the in-booth performance of CP1110 and Nucleus 7 Sound Processors.

Conditions: Adult Cochlear Implant Recipients
Being tested: CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF), Nucleus 7 Sound Processor (model: CP1000) system, CP1110 Sound Processor System with ForwardFocus Off (SCAN 2)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF)Device
Sound Processor
Nucleus 7 Sound Processor (model: CP1000) systemDevice
Sound Processor
CP1110 Sound Processor System with ForwardFocus Off (SCAN 2)Device
Sound Processor

Study groups in NCT05080283
Study group	Role	What they receive
CP1110 with automated ForwardFocus On (SCAN 2 FF), CP1110 with ForwardFocus Off (SCAN 2), and CP1000	Other	All participants assigned to CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF), CP1110 Sound Processor System with ForwardFocus Off (SCAN 2) compared to the previously marketed Nucleus 7 Sound Processor (Model: CP1000) in a random order. Receives: Device: CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF); Device: Nucleus 7 Sound Processor (model: CP1000) system; Device: CP1110 Sound Processor System with ForwardFocus Off (SCAN 2)

What is being measured

The primary outcome is the main question the study is designed to answer.

Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0Nrearhalf)
Paired difference in dB SRT (AuSTIN) between the CP1110 Sound Processor with automated ForwardFocus ON (SCAN 2 FF) and ForwardFocus OFF (SCAN 2) in 65 dB SPL S0Nrearhalf 4TB.
Measured: 6 months

Secondary outcomes (3)

Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0N3)
Paired difference in dB SRT (AuSTIN) between the CP1110 Sound Processor with automated ForwardFocus On (SCAN 2 FF) and ForwardFocus OFF (SCAN 2) in 65 dB SPL S0N3 Babble.
Measured: 6 months
Adult Cochlear Implant Recipient Speech Perception in Quiet With the CP1110 Sound Processor and the Nucleus 7 Sound Processor
Paired difference in percentage CNC Words correct in quiet (50 dB) with the CP1110 Sound Processor and Nucleus 7 Sound Processor.
Measured: 6 months
Adult Cochlear Implant Subjective Hearing Performance and Sound Quality With the CP1110 Sound Processor and Nucleus 7 Sound Processor
Paired difference in Global Speech, Spatial and Qualities of Hearing Scale (SSQ12) scores after experience with the CP1110 Sound Processor and Nucleus 7 Sound Responses. SSQ12 have a minimum value of 0 and a maximum of 10, wherein a higher score means a better outcome.
Measured: Baseline (Nucleus 7) and Visit 2 (6 months, CP1110)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Nov 202113 Sep 2022

First posted15 Oct 2021
Study start2 Nov 2021
Primary completion13 Sep 2022
Study completion13 Sep 2022

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 Adult Cochlear Implant RecipientsStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Prospective, pre-market, single-site, non-randomized.
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05080283
Sponsor's protocol ID: CLTD5810
Acronym: PINNA
Status last verified: Jan 2025
First submitted: 19 Sep 2021
Last updated: 25 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Nel E, Hong W, Playford J, Mashal ME. A clinical and real-world investigation of cochlear implant recipient speech performance in noise with the automation of ForwardFocus. Int J Audiol. 2026 May;65(5):600-608. doi: 10.1080/14992027.2025.2561889. Epub 2025 Oct 4.
PubMed 41046328

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
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All Adult Cochlear Implant Recipients trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pre-Marketing, Prospective, Single-Site, Open-Label, Within-Subject, Actual-Use, Interventional Study of Acceptance and Performance With Experienced Adult Cochlear Implant Recipients Using the CP1110 Sound Processor Compared With the CP1000 Sound Processor
ClinicalTrials.gov ID: NCT05080283
Acronym / sponsor ID: PINNA / CLTD5810
Conditions: Adult Cochlear Implant Recipients
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: CochlearIndustry (pharma, biotech, devices)
Collaborators: Avania
Study start: 2 Nov 2021 (actual)
Primary completion: 13 Sep 2022 (actual)
Study completion: 13 Sep 2022 (actual)
First posted: 15 Oct 2021 (actual)
Results: Posted 25 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Prospective, pre-market, single-site, non-randomized.

Arm	Type	Receives
CP1110 with automated ForwardFocus On (SCAN 2 FF), CP1110 with ForwardFocus Off (SCAN 2), and CP1000	Other	Device: CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF), Device: Nucleus 7 Sound Processor (model: CP1000) system, Device: CP1110 Sound Processor System with ForwardFocus Off (SCAN 2)All participants assigned to CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF), CP1110 Sound Processor System with ForwardFocus Off (SCAN 2) compared to the previously marketed Nucleus 7 Sound Processor (Model: CP1000) in a random order.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: 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) or Freedom Series (CI24RE(CA), CI24RE(ST), CI422).
At least 6 months experience with a cochlear implant.
At least 3 months experience with a Nucleus 7 (CP1000) Sound Processor

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.

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
CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF)Sound Processor	Device	CP1110 with automated ForwardFocus On (SCAN 2 FF), CP1110 with ForwardFocus Off (SCAN 2), and CP1000
Nucleus 7 Sound Processor (model: CP1000) systemSound Processor	Device	CP1110 with automated ForwardFocus On (SCAN 2 FF), CP1110 with ForwardFocus Off (SCAN 2), and CP1000
CP1110 Sound Processor System with ForwardFocus Off (SCAN 2)Sound Processor	Device	CP1110 with automated ForwardFocus On (SCAN 2 FF), CP1110 with ForwardFocus Off (SCAN 2), and CP1000

Primary outcome

Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0Nrearhalf)
Time frame: 6 months
Paired difference in dB SRT (AuSTIN) between the CP1110 Sound Processor with automated ForwardFocus ON (SCAN 2 FF) and ForwardFocus OFF (SCAN 2) in 65 dB SPL S0Nrearhalf 4TB.

3 secondary outcomes

Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0N3)
Time frame: 6 months
Adult Cochlear Implant Recipient Speech Perception in Quiet With the CP1110 Sound Processor and the Nucleus 7 Sound Processor
Time frame: 6 months
Adult Cochlear Implant Subjective Hearing Performance and Sound Quality With the CP1110 Sound Processor and Nucleus 7 Sound Processor
Time frame: Baseline (Nucleus 7) and Visit 2 (6 months, CP1110)

Results and safety

Results posted to the registry on 25 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	20	20

Primary outcome: Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0Nrearhalf)

Time frame: 6 months. Mean (95% Confidence Interval). Unit: dB SRT

Measure	Within-subject Comparison of CP1110 ForwardFocus On Versus ForwardFocus Off in S0Nrearhalf n = 20
CP1110 ForwardFocus On	-10.34 (-11.10 to -9.57)
CP1110 ForwardFocus Off	-6.04 (-7.32 to -4.76)
Difference between CP1110 ForwardFocus On and ForwardFocus off	-4.30 (-5.19 to -3.41)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 20 (0%)	13 of 20 (65%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41046328Nel E, Hong W, Playford J, Mashal ME. A clinical and real-world investigation of cochlear implant recipient speech performance in noise with the automation of ForwardFocus. Int J Audiol. 2026 May;65(5):600-608. doi: 10.1080/14992027.2025.2561889. Epub 2025 Oct 4.
Individual participant dataSharing planned: No

Related trials for Adult Cochlear Implant Recipients

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Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
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An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
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An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App
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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?

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 25 Mar 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 25 Mar 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?

Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0Nrearhalf) (time frame: 6 months). 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 NCT05080283, 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 25 Mar 2025.