Sensorineural Hearing LossNCT04741048
Hearing Implant Performance in Adults With Low-Frequency Residual Hearing
A study testing CI624 Slim 20 Electrode in people with Sensorineural Hearing Loss and Low-Frequency Residual Hearing, run by Cochlear at 1 site in United States.
Trial summary
The purpose of the feasibility study is to investigate hearing performance (audiometry and speech perception) using the CI624 in a group of adults (n=15) with low-frequency residual hearing who meet inclusion criteria. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sensorineural Hearing Loss, Low-Frequency Residual Hearing
- What is being tested?
- CI624 Slim 20 Electrode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2021to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years-of-age or older at the time of surgery.
- Low-frequency threshold at 500 Hz ≤ 50 dB HL and high-frequency pure-tone average (PTA), 2000-8000 Hz ≥ 65 dB HL in the ear to be implanted.
- Pure-tone average (PTA) (0.5k, 1k, 2k Hz) > 30 dB HL in the contralateral ear.
- CNC word recognition scores (mean of two lists) ≤ 60% in the ear to be implanted and ≤ 80% in the contralateral ear.
- English spoken as a primary language.
- Willing and able to provide written informed consent.
Who cannot join
- Individuals older than 70 years at the time of surgery.
- Duration of severe to profound sensorineural hearing loss > 20 years per self-report.
- Onset of sensorineural hearing loss, for the purpose of this study, prior to 5 years-of-age.
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
- Conductive overlay of 15 dB or greater at two or more frequencies, in the range of 250 through 1000 Hz in the ear to be implanted.
- Hearing loss of neural or central origin.
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- Diagnosis of Auditory Neuropathy.
- Active middle-ear infection.
- Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator.
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the device and/or procedure, as determined by the Investigator.
- Additional handicaps that would prevent or restrict participation in the audiological evaluations 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 family (spouse, parent, child, or sibling).
- Cochlear employees or employees of a Contract Research Organization (CRO) or contractors engaged by Cochlear for the purposes of this investigation.
- Currently participating, or has participated in the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jacksonville Hearing and Balance
Jacksonville, Florida, 32256
About this study
Official title: A Pre-market, Open-label Feasibility, Prospective, Single-arm Multicenter Feasibility Investigation of Hearing Performance Using the CI624 in Adults With Low-frequency Residual Hearing.
The purpose of the feasibility study is to investigate hearing performance (audiometry and speech perception) using the CI624 in a group of adults (n=15) with low-frequency residual hearing who meet inclusion criteria.
- Being tested
- CI624 Slim 20 Electrode
- 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.
CI624 Slim 20 ElectrodeDevice
Cochlear Ltd CI624 cochlear implant with Slim 20 Electrode
| Study group | Role | What they receive |
|---|---|---|
| CI624 Slim 20 Electrode | Experimental | Not described Receives: Device: CI624 Slim 20 Electrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize hearing performance of the CI624.
Hearing performance of the CI624 will characterized using Constant Nucleus Constant (CNC) word recognition in quiet. Performance is scored as percent correct words.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start8 Mar 2021
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Why it stopped: Sponsor decided to cancel the study prior to any subjects being enrolled/consented due to the lack of CMS coverage and an internal staffing shortage.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing LossStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741048
- Sponsor's protocol ID
- CAM5777
- Status last verified
- Sep 2021
- First submitted
- 10 Jan 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-market, Open-label Feasibility, Prospective, Single-arm Multicenter Feasibility Investigation of Hearing Performance Using the CI624 in Adults With Low-frequency Residual Hearing.
- ClinicalTrials.gov ID
- NCT04741048
- Acronym / sponsor ID
- CAM5777
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decided to cancel the study prior to any subjects being enrolled/consented due to the lack of CMS coverage and an internal staffing shortage.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the feasibility study is to investigate hearing performance (audiometry and speech perception) using the CI624 in a group of adults (n=15) with low-frequency residual hearing who meet inclusion criteria.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CI624 Slim 20 Electrode | Experimental | Device: CI624 Slim 20 Electrode |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years-of-age or older at the time of surgery.
- Low-frequency threshold at 500 Hz ≤ 50 dB HL and high-frequency pure-tone average (PTA), 2000-8000 Hz ≥ 65 dB HL in the ear to be implanted.
- Pure-tone average (PTA) (0.5k, 1k, 2k Hz) > 30 dB HL in the contralateral ear.
- CNC word recognition scores (mean of two lists) ≤ 60% in the ear to be implanted and ≤ 80% in the contralateral ear.
- English spoken as a primary language.
Key exclusion criteria (15 listed)
- Individuals older than 70 years at the time of surgery.
- Duration of severe to profound sensorineural hearing loss > 20 years per self-report.
- Onset of sensorineural hearing loss, for the purpose of this study, prior to 5 years-of-age.
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
- Conductive overlay of 15 dB or greater at two or more frequencies, in the range of 250 through 1000 Hz in the ear to be implanted.
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 |
|---|---|---|
| CI624 Slim 20 ElectrodeCochlear Ltd CI624 cochlear implant with Slim 20 Electrode | Device | CI624 Slim 20 Electrode |
Primary outcome
Characterize hearing performance of the CI624.
Time frame: 14 months
Hearing performance of the CI624 will characterized using Constant Nucleus Constant (CNC) word recognition in quiet. Performance is scored as percent correct words.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
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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 CI624 Slim 20 Electrode in people with Sensorineural Hearing Loss and Low-Frequency Residual Hearing, run by Cochlear at 1 site in United States.
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 6 inclusion and 15 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: withdrawn, as of the sponsor's last update on 6 Oct 2021. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Characterize hearing performance of the CI624. (time frame: 14 months). 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 6 Oct 2021.