Hearing Loss in Older Adults Study

Stopped early · Not applicable

Conditions studied: Hearing Loss, Sensorineural, Hearing Loss, Bilateral

In brief

This is a prospective, 1:1 randomized controlled trial of immediate versus delayed cochlear implantation (CI) on hearing handicap, communicative function, loneliness, mental wellbeing, and cognitive functioning. Participants are randomized 1:1 to an immediate cochlear implant intervention group versus a hearing aid control intervention.

Key facts

Study ID

NCT03382769

Run by

Cochlear

People needed

1

Starts

2019-03-27

Expected to finish

2020-01-04

Last updated by the study team

2022-12-22

Who can join

Age: 65 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Center for Neurosciences — Tucson, Arizona, United States
• House Ear Institute — Los Angeles, California, United States
• Washington University — St Louis, Missouri, United States
• New York Eye and Ear Infirmary of Mount Sinai — New York, New York, United States
• University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States
• University of Cincinnati Health — Cincinnati, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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