New cochlear implant aims to help those with partial hearing hear better
NCT ID NCT04741009
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Low-frequency residual hearing are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Turmeric compound tested against the ringing in millions of ears
- Hearing loss in children may hide a balance problem, and doctors are testing for it
- Could talking it out boost hearing aid success?
- Is hearing loss becoming a bigger cause of disability? a national study digs into the data
- Can an antiviral drug protect hearing in infants with congenital CMV?
- Could a new test help hearing aid users hear better in crowds?