Trial Information
Current as of May 11, 2025
Terminated
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Community-dwelling
- • Proficient in English
- • Oral communicator
- • PTA (500, 1000 \& 2000 Hz) ≥ 70 dB HL hearing loss duration ≥1 and no more than 30 years
- • Active daily hearing aid users
- • HHIE-S score greater than or equal to 24
- • MoCA score greater than or equal to 20
- • Post-linguistic onset sensorineural hearing loss and meet applicable FDA and/or Medicare candidacy criteria for cochlear implantation
- • Willing to consent for the study, to be randomized to either group, to utilize bimodal hearing for the duration of the trial (if clinically appropriate), and follow the study protocol
- Exclusion Criteria:
- • Prelingual or perilingual severe-to-profound hearing loss
- • Previous cochlear implantation in either ear
- • Hearing loss of neural or central origin
- • Permanent conductive hearing impairment (e.g. otosclerosis)
- • Medical, audiological, or psychological conductions that might contraindicate participation in the clinical investigation
- • Self reported disability in 2 or more activities of daily living
- • Vision impairment worse than 20/40 on a near vision card
About Cochlear
Cochlear Limited is a global leader in implantable hearing solutions, dedicated to transforming the lives of individuals with hearing loss through innovative technology and comprehensive clinical research. With a strong commitment to advancing auditory rehabilitation, Cochlear conducts rigorous clinical trials aimed at evaluating the safety and efficacy of its products, including cochlear implants and bone conduction devices. The company collaborates with healthcare professionals and research institutions worldwide to ensure that its solutions meet the highest standards of quality and performance, ultimately enhancing patient outcomes and promoting accessibility to hearing health care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Milwaukee, Wisconsin, United States
Chapel Hill, North Carolina, United States
Columbus, Ohio, United States
Saint Louis, Missouri, United States
Cincinnati, Ohio, United States
Tucson, Arizona, United States
New York, New York, United States
Patients applied
Trial Officials
David N Cade, MD, MBA
Study Director
Cochlear
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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