Sensorineural Hearing LossNCT04741009
Perimodiolar Implant Performance in Adults With Low-Frequency Residual Hearing
A study testing CI632 Slim Modiolar Electrode in people with Sensorineural Hearing Loss and Low-Frequency Residual Hearing, run by Cochlear at 4 sites in United States.
Trial summary
The purpose of the feasibility study is to investigate hearing performance (audiometry and speech perception) using the CI632 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 69 years
- Conditions the study is for
- Sensorineural Hearing Loss, Low-Frequency Residual Hearing
- What is being tested?
- CI632 Slim Modiolar Electrode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Dec 2021to 16 Jun 2025
- 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 to 69 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 greater than or equal to 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
4 sites in 1 country.
United States4 sites
Cleveland Clinic
Cleveland, Ohio, 44106
University Hospitals
Cleveland, Ohio, 44106
Midwest Ear Institute
Kansas City, Missouri, 64111
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: A Pre-market, Open-label Feasibility, Prospective, Single-arm Multicenter Feasibility Investigation of Hearing Performance Using the CI632 in Adults With Low-frequency Residual Hearing.
The purpose of the feasibility study is to investigate hearing performance (audiometry and speech perception) using the CI632 in a group of adults (n=15) with low-frequency residual hearing who meet inclusion criteria.
- Being tested
- CI632 Slim Modiolar 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.
CI632 Slim Modiolar ElectrodeDevice
Cochlear Ltd CI632 cochlear implant with Slim Modiolar Electrode
| Study group | Role | What they receive |
|---|---|---|
| CI632 Slim Modiolar Electrode | Experimental | Not described Receives: Device: CI632 Slim Modiolar Electrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Characterize Hearing Performance of the CI632 in an Adult Population Under Expanded Indications for Use.
To characterize hearing performance of the CI632 using the Consonant-Nucleus-Consonant (CNC) monosyllabic word recognition test in quiet (unilateral). Two CNC word lists will be administered at a level equal to 60 dBA in the sound field and scored as a total number of words correct, expressed as a percentage correct.
Measured: 14 months (12 months postactivation)
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 start16 Dec 2021
- Primary completion16 Jun 2025
- Study completion16 Jun 2025
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 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741009
- Sponsor's protocol ID
- CAM5776
- Status last verified
- Aug 2024
- First submitted
- 6 Jan 2021
- Last updated
- 17 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. 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 CI632 in Adults With Low-frequency Residual Hearing.
- ClinicalTrials.gov ID
- NCT04741009
- Acronym / sponsor ID
- CAM5776
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Posted 24 Jun 2026
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 CI632 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 |
|---|---|---|
| CI632 Slim Modiolar Electrode | Experimental | Device: CI632 Slim Modiolar Electrode |
Who may qualify
- Ages
- 18 to 69 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 greater than or equal to 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 |
|---|---|---|
| CI632 Slim Modiolar ElectrodeCochlear Ltd CI632 cochlear implant with Slim Modiolar Electrode | Device | CI632 Slim Modiolar Electrode |
Primary outcome
To Characterize Hearing Performance of the CI632 in an Adult Population Under Expanded Indications for Use.
Time frame: 14 months (12 months postactivation)
To characterize hearing performance of the CI632 using the Consonant-Nucleus-Consonant (CNC) monosyllabic word recognition test in quiet (unilateral). Two CNC word lists will be administered at a level equal to 60 dBA in the sound field and scored as a total number of words correct, expressed as a percentage correct.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CI632 Slim Modiolar Electrode in people with Sensorineural Hearing Loss and Low-Frequency Residual Hearing, run by Cochlear at 4 sites 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: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 24 Jun 2026). 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?
To Characterize Hearing Performance of the CI632 in an Adult Population Under Expanded Indications for Use. (time frame: 14 months (12 months postactivation)). 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 17 Aug 2026.