Hearing Impairment, SensorineuralNCT05286385
CP1150 Sound Processor Speech Perception Compared With the Next Generation of Signal Processing Technology
A study testing CP1150 Sound Processor, CP1150 NF and CP1150 + FF in people with Hearing Impairment, Sensorineural, run by Cochlear at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Impairment, Sensorineural
- What is being tested?
- CP1150 Sound Processor, CP1150 NF and CP1150 + FF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- 30 May 2022to 29 Jun 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
- 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, 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
Show all 10Show fewer
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Hearing Impairment, Sensorineural
- Being tested
- CP1150 Sound Processor, CP1150 NF, CP1150 + FF, CP1110
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP1150 Sound ProcessorDevice
Speech perception tests whilst the subject is fitted with the CP1150 Sound Processor
CP1150 NFDevice
Speech perception tests whilst the subject is fitted with the CP1150 modified firmware (the addition of notch filters at 978Hz, 1956Hz, 2934Hz, 3912Hz).
CP1150 + FFDevice
Speech perception tests whilst the subject is fitted with the CP1150 Sound Processor with ForwardFocus.
CP1110Device
Speech perception tests whilst the subject is fitted with the CP1110 Sound Processor.
| Study group | Role | What they receive |
|---|---|---|
| Test Order 1 | Experimental | CP1150, then CP1150 NF, then CP1110, then CP1150 + FF Receives: Device: CP1150 Sound Processor; Device: CP1150 NF; Device: CP1150 + FF; Device: CP1110 |
| Test Order 2 | Experimental | CP1150 NF, then CP1150 + FF, then CP1150, then CP1110 Receives: Device: CP1150 Sound Processor; Device: CP1150 NF; Device: CP1150 + FF; Device: CP1110 |
| Test Order 3 | Experimental | CP1150 + FF, then CP1110, then CP1150 NF, then CP1150 Receives: Device: CP1150 Sound Processor; Device: CP1150 NF; Device: CP1150 + FF; Device: CP1110 |
| Test Order 4 | Experimental | CP1110, thenCP1150, then CP1150 + FF, then CP1150 NF Receives: Device: CP1150 Sound Processor; Device: CP1150 NF; Device: CP1150 + FF; Device: CP1110 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Perception in Quiet Using an CP1150 Sound Processor
Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with modified firmware.
Measured: One day (in booth testing)
Secondary outcomes (2)
Speech Perception in Quiet Using CP1150 Sound Processor Using Forward Focus Combined With Standard Microphone Directionality.
Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with forward focus
Measured: One day (in booth testing)
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
Measured: One day (in booth testing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start30 May 2022
- Primary completion29 Jun 2022
- Study completion29 Jun 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.
- Other trials for Hearing Impairment, SensorineuralStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT05286385
- Sponsor's protocol ID
- CLTD5818
- Status last verified
- Feb 2024
- First submitted
- 22 Feb 2022
- Last updated
- 7 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 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, Pilot, Interventional Study of Adult Cochlear Implant Speech Perception With the CP1150 Sound Processor Compared With the Next Generation of Signal Processing Technology
- ClinicalTrials.gov ID
- NCT05286385
- Acronym / sponsor ID
- CLTD5818
- Conditions
- Hearing Impairment, Sensorineural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 30 May 2022 (actual)
- Primary completion
- 29 Jun 2022 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Posted 5 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test Order 1 | Experimental | Device: CP1150 Sound Processor, Device: CP1150 NF, Device: CP1150 + FF, Device: CP1110CP1150, then CP1150 NF, then CP1110, then CP1150 + FF |
| Test Order 2 | Experimental | Device: CP1150 Sound Processor, Device: CP1150 NF, Device: CP1150 + FF, Device: CP1110CP1150 NF, then CP1150 + FF, then CP1150, then CP1110 |
| Test Order 3 | Experimental | Device: CP1150 Sound Processor, Device: CP1150 NF, Device: CP1150 + FF, Device: CP1110CP1150 + FF, then CP1110, then CP1150 NF, then CP1150 |
| Test Order 4 | Experimental | Device: CP1150 Sound Processor, Device: CP1150 NF, Device: CP1150 + FF, Device: CP1110CP1110, thenCP1150, then CP1150 + FF, then CP1150 NF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| CP1150 Sound ProcessorSpeech perception tests whilst the subject is fitted with the CP1150 Sound Processor | Device | Test Order 1, Test Order 2, Test Order 3, Test Order 4 |
| CP1150 NFSpeech perception tests whilst the subject is fitted with the CP1150 modified firmware (the addition of notch filters at 978Hz, 1956Hz, 2934Hz, 3912Hz). | Device | Test Order 1, Test Order 2, Test Order 3, Test Order 4 |
| CP1150 + FFSpeech perception tests whilst the subject is fitted with the CP1150 Sound Processor with ForwardFocus. | Device | Test Order 1, Test Order 2, Test Order 3, Test Order 4 |
| CP1110Speech perception tests whilst the subject is fitted with the CP1110 Sound Processor. | Device | Test Order 1, Test Order 2, Test Order 3, Test Order 4 |
Primary outcome
Speech Perception in Quiet Using an CP1150 Sound Processor
Time frame: One day (in booth testing)
Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with modified firmware.
2 secondary outcomes
Speech Perception in Quiet Using CP1150 Sound Processor Using Forward Focus Combined With Standard Microphone Directionality.
Time frame: One day (in booth testing)
Speech Perception in Quiet With CP1150 and CP1110 Sound Processors
Time frame: One day (in booth testing)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 CP1150 Sound Processor, CP1150 NF and CP1150 + FF in people with Hearing Impairment, Sensorineural, 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 10 inclusion and 7 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 7 Feb 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 5 Aug 2024). 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 Perception in Quiet Using an CP1150 Sound Processor (time frame: One day (in booth testing)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2025.