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New cochlear implant aims to help those with partial hearing hear better

NCT ID NCT04741009

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 2 times

Summary

This study tested a new cochlear implant (CI632) in 10 adults who have some low-frequency hearing but poor high-frequency hearing. The goal was to see if the implant improves speech understanding and overall hearing. Participants received the implant and were followed to measure hearing performance.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CI632 cochlear implant with Slim Modiolar Electrode
What this could lead to
If successful, this implant could help adults with low-frequency hearing loss hear speech more clearly, expanding who can benefit from cochlear implants.
What could go wrong
This is a small, early feasibility study with only 10 participants, so results may not apply to everyone. The implant is a device, not a cure, and hearing may still require ongoing management.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

10 people

The number who actually took part.

Started

Dec 2021

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 69 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 18 years-of-age or older at the time of surgery. 2. 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. 3. Pure-tone average (PTA) (0.5k, 1k, 2k Hz) \> 30 dB HL in the contralateral ear. 4. CNC word recognition scores (mean of two lists) ≤ 60% in the ear to be implanted and ≤ 80% in the contralateral ear. 5. English spoken as a primary language. 6. Willing and able to provide written informed consent. Exclusion Criteria: 1. Individuals greater than or equal to 70 years at the time of surgery. 2. Duration of severe to profound sensorineural hearing loss \> 20 years per self-report. 3. Onset of sensorineural hearing loss, for the purpose of this study, prior to 5 years-of-age. 4. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array. 5. 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. 6. Hearing loss of neural or central origin. 7. Diagnosis of Auditory Neuropathy. 8. Active middle-ear infection. 9. Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator. 10. 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. 11. Additional handicaps that would prevent or restrict participation in the audiological evaluations as determined by the Investigator. 12. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator. 13. Investigator site personnel directly affiliated with this study and/or their immediate family (spouse, parent, child, or sibling). 14. Cochlear employees or employees of a Contract Research Organization (CRO) or contractors engaged by Cochlear for the purposes of this investigation. 15. Currently participating, or has participated in the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44106, United States

  • Midwest Ear Institute

    Kansas City, Missouri, 64111, United States

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655, United States

  • University Hospitals

    Cleveland, Ohio, 44106, United States

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