Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population (NCT06293482)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
This study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet the FDA-approved indications for cochlear implantation. Following cochlear implantation, participants will complete speech perception assessments and questionnaires over the course of seven visits.
Who can join: Review the eligibility criteria below.
Location: Barrow Neurological Institute โ Phoenix, Arizona
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (9 Sites)
- Barrow Neurological Institute โ Phoenix, Arizona
- Centre for Neurosciences โ Tucson, Arizona
- Pacific Neuroscience Institute โ Santa Monica, California
- University of Miami โ Coral Gables, Florida
- Indiana University โ Indianapolis, Indiana
- Midwest Ear Institute โ Kansas City, Missouri
- New York University โ New York, New York
- Cleveland Clinic โ Cleveland, Ohio
- University of Pennsylvania Hospitals โ Philadelphia, Pennsylvania
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Hearing Loss, Sensorineural
- Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery โ Iowa City, Iowa
- Clinical Utility of Residual Hearing in the Cochlear Implant Ear โ Rochester, Minnesota
- Barriers and Facilitators to OTC Hearing Aids Success โ Iowa City, Iowa
- Characterizing Variability in Hearing Aid Outcomes in Among Older Adults With Alzheimer's Dementia โ Chicago, Illinois
Explore by condition: All Hearing Loss, Sensorineural clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.