Could cochlear implants help more people hear? new study expands eligibility.
NCT ID NCT06293482
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether cochlear implants are safe and effective for adults with severe hearing loss in both ears who currently don't meet standard implant criteria. Fifty participants will receive an implant and be followed for 6 months to measure improvements in word recognition and sentence understanding in noise. The goal is to see if expanding who can get these implants can help more people hear better.
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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 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Oct 2028
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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18 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 or older at the time of consent * Meets the following audiometric criteria for the ear to be implanted: clinically established sensorineural hearing loss (SNHL) defined by a four frequency pure tone average (PTA) at 500, 1000, 2000, \& 4000 Hz of: ≥60 dB HL and compromised functional hearing in the aided condition defined as \<50% correct on a word recognition test * Meets the following audiometric criteria for the non-implanted contralateral ear: clinically established SNHL defined by a four frequency PTA at 500, 1000, 2000, \& 4000 Hz of \>30 dB HL * Candidate is a fluent speaker in the language used to assess speech perception performance as determined by the investigator. * Willing and able to provide written informed consent. Exclusion Criteria: * Meets current indications on audiometric thresholds for traditional adult CI candidates (i.e., bilateral moderate to profound hearing loss in the low frequencies and profound \[≥ 90 dB HL\] hearing loss in the mid to high speech frequencies) * Absence of cochlea development or a cochlear nerve * Presence of active middle ear infection in the ear to be implanted * Tympanic membrane perforation in the presence of active middle ear disease in the ear to be implanted * Medical or psychological conditions that contraindicate general anaesthesia, surgery, or participation in the clinical investigation. * Existing contralateral cochlear implant or medical plan to implant a contralateral cochlear implant during the clinical investigation. * Pregnant or breastfeeding women. Women who plan to become pregnant during the course of the clinical investigation. * Unrealistic expectations on the part of the participant, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the investigator. * Additional disabilities that may affect the participant's participation of safety during the clinical investigation. * Unable or unwilling to comply with all of 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. * Employees of Cochlear. * Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation.
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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
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Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
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Centre for Neurosciences
Tucson, Arizona, 85718, United States
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Indiana University
Indianapolis, Indiana, 46202, United States
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Midwest Ear Institute
Kansas City, Missouri, 64111, United States
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New York University
New York, New York, 10016, United States
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Pacific Neuroscience Institute
Santa Monica, California, 90404, United States
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University of Miami
Coral Gables, Florida, 33146, United States
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University of Pennsylvania Hospitals
Philadelphia, Pennsylvania, 19104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a custom sound map unlock better hearing for cochlear implant users?
- Can a new bone conduction implant restore hearing for the long haul?
- Can brain scans unlock the secret to hearing in crowded rooms?
- Can eye movements reveal the hidden toll of hearing loss?
- Could a blood concentrate make cochlear implants work better?