๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-01

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

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Cochlear

๐Ÿฉบ 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

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ 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

๐Ÿ’ฐ 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—