Cochlear implants could help those deaf in one ear hear better in noise
NCT ID NCT05318417
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study is testing whether a cochlear implant can help children and adults who have severe hearing loss or deafness in one ear but normal hearing in the other. The implant is a device placed behind the ear and under the skin that sends electrical signals to the hearing nerve. Researchers will measure how well participants can hear speech in noisy settings and track any side effects over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cochlear™ Nucleus® Cochlear Implant System (a surgically implanted device that converts sound into electrical signals to stimulate the auditory nerve)
- What this could lead to
- If successful, this could confirm that cochlear implants are a safe and effective option for people with single-sided deafness, improving their ability to hear in noisy environments.
- What could go wrong
- This is a post-approval study with only 60 participants, so results may not apply to everyone. Risks include surgery-related complications and device issues.
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
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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
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2022
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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5 years and older
- Sex
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Anyone
- Healthy volunteers
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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: • Individuals 18 years or older (Group A) Ear to be Implanted: Severe sensorineural hearing loss (HL) defined as: Pure-tone average at 0.5, 1, 2, 4 kHz \>80 dB HL ; Aided Consonant-Nucleus-Consonant Test (CNC) score ≤5% and Normal Hearing Ear: Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL • Children 5 years to 17 years, 11 months (Group B) Ear to be Implanted: Severe sensorineural HL defined as: Pure-tone average at 0.5, 1, 2, 4 kHz \>80 dB HL; Aided CNC score ≤5% and Normal Hearing Ear: Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL * Previous experience with a current conventional treatment option for unilateral \[SSD\] HL (HA, bone-conduction device, or CROS technology), if no previous experience a minimum trial period of two weeks is required * English spoken as a primary language * Willing and able to provide written informed consent Exclusion Criteria: * Ossification, abnormal cochlear nerve or any other cochlear anomaly that might prevent complete insertion of the electrode array * Previous cochlear implantation * Hearing loss of neural or central origin, including auditory neuropathy * Duration of profound sensorineural HL \>10 years per self-report * Active / chronic middle-ear infection; conductive HL in either ear * Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator * Unrealistic expectations on the part of the participant/family, regarding the possible benefits, risks, and limitations that are inherent as determined by the Investigator * Evidence of and/or suspected cognitive or developmental concern * 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 Organizations (CROs) or contractors engaged by Cochlear for the purposes of this investigation * Pregnant or breastfeeding women * Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
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Get notified about this study
Sign up to get updates when this study changes or when new studies for Deafness, unilateral 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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Nationwide Children's Hospital
WITHDRAWNColumbus, Ohio, 43205, United States
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New York Eye and Ear Infirmary
RECRUITINGNew York, New York, 10003, United States
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Rocky Mountain Ear Center
RECRUITINGEnglewood, Colorado, 80113, United States
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Stanford University
RECRUITINGPalo Alto, California, 94304, United States
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University of Iowa
RECRUITINGIowa City, Iowa, 52242, United States
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University of North Carolina
RECRUITINGChapel Hill, North Carolina, 27517, United States
Contact Email: •••••@•••••
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University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck Surgery
WITHDRAWNDallas, Texas, 75390, United States
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Virginia Mason Medical Center
RECRUITINGSeattle, Washington, 98101, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new bone conduction implant restore hearing for the long haul?
- Could a cochlear implant help babies hear in one ear?
- Brain scans reveal how deafness in one ear rewires Kids' hearing centers
- Which hearing test works best for preschoolers? major study aims to find out
- Robot arm aims to improve cochlear implant surgery for kids
- Hearing aid study explores link between better hearing and brain health