Evaluating cochlear implants for adults with severe hearing loss
A Pivotal, Prospective, Open-label, Multi-center Study of Safety and Effectiveness of Cochlear Implantation in an Expanded Population of Adults With Bilateral Sensorineural Hearing Loss
This study is testing if cochlear implants can help adults with severe hearing loss who don’t meet the usual requirements for the surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cochlear Industry-sponsored |
| Locations | 11 sites (Phoenix, Arizona and 10 other locations) |
| Trial ID | NCT06293482 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of cochlear implantation in adults with bilateral sensorineural hearing loss who do not meet the current FDA-approved criteria for the procedure. Participants will undergo cochlear implantation and will be assessed through speech perception tests and questionnaires over seven visits. The goal is to determine if these individuals can benefit from cochlear implants despite not fitting traditional candidacy requirements.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with significant bilateral sensorineural hearing loss who do not meet traditional cochlear implant criteria.
Not a fit: Patients who meet the current FDA indications for cochlear implantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could expand treatment options for adults with severe hearing loss who currently lack access to cochlear implants.
How similar studies have performed: Other studies have explored cochlear implantation in broader populations, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Phoenix, Arizona and 10 other locations
- Barrow Neurological Institute — Phoenix, Arizona, United States (Recruiting)
- Centre for Neurosciences — Tucson, Arizona, United States (Recruiting)
- Pacific Neuroscience Institute — Santa Monica, California, United States (Recruiting)
- University of Miami — Coral Gables, Florida, United States (Recruiting)
- Indiana University — Indianapolis, Indiana, United States (Recruiting)
- Midwest Ear Institute — Kansas City, Missouri, United States (Recruiting)
- New York University — New York, New York, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- University of Pennsylvania Hospitals — Philadelphia, Pennsylvania, United States (Recruiting)
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
- Virginia Mason — Seattle, Washington, United States (Withdrawn)
Study contacts
- Study coordinator: Lavin Entwisle
- Email: lentwisle@cochlear.com
- Phone: 605-354-2917
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.