Hearing Loss in Older Adults Study

Not Applicable

Terminated

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Group A (Immediate Cochlear Implantation)	Cochlear implantation	Group A will consist of 30 individuals who are candidates for cochlear implantation. They will be unilaterally implanted immediately after initial study testing has been completed and then be followed for 12 months after device activation.
Group B (Delayed Cochlear Implantation)	Cochlear implantation	Group B will consist of 30 individuals who are candidates for cochlear implantation. They will continue to wear hearing aids after enrolling in the study and then be unilaterally implanted 6 months after enrollment and followed for 6 more months after device activation.

Primary Outcome Measures

Name	Time	Method
Hearing Handicap	6 months after enrollment	The SSQ-12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item. Assessment of the impact of cochlear implantation versus continued hearing aid is then calculated and the theoretical score could vary between -10 to + 10. The higher the score the better benefit and positive score indicates improved hearing, a negative value an impaired hearing.

Secondary Outcome Measures

Name	Time	Method

Locations (8): House Ear Institute
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Los Angeles, California, United States
Arizona Center for Neurosciences
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Tucson, Arizona, United States
Washington University
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Saint Louis, Missouri, United States
New York Eye and Ear Infirmary of Mount Sinai
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New York, New York, United States
University of North Carolina Chapel Hill
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Chapel Hill, North Carolina, United States
University of Cincinnati Health
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Cincinnati, Ohio, United States
Ohio State University
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Columbus, Ohio, United States
Medical College of Wisconsin
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Milwaukee, Wisconsin, United States