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Cochlear implants could help those deaf in one ear hear better in noise

NCT ID NCT05318417

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Jun 2027

An estimate. End dates often move.

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

5 years and older

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: • 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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Conditions

The condition(s) this trial relates to.

deafness, unilateral Hearing Loss, Unilateral

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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    6 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Locations

  • Nationwide Children's Hospital

    WITHDRAWN

    Columbus, Ohio, 43205, United States

  • New York Eye and Ear Infirmary

    RECRUITING

    New York, New York, 10003, United States

  • Rocky Mountain Ear Center

    RECRUITING

    Englewood, Colorado, 80113, United States

  • Stanford University

    RECRUITING

    Palo Alto, California, 94304, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of North Carolina

    RECRUITING

    Chapel Hill, North Carolina, 27517, United States

    Contact Email: •••••@•••••

  • University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck Surgery

    WITHDRAWN

    Dallas, Texas, 75390, United States

  • Virginia Mason Medical Center

    RECRUITING

    Seattle, Washington, 98101, United States

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