Hearing Loss in Older Adults Study

Study Overview
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Brief Summary
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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.

Official Title
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Hearing Loss in Older Adults: A Randomized Controlled Trial of Immediate Versus Delayed Cochlear Implantation.

Conditions
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Hearing Loss, Sensorineural, Hearing Loss, Bilateral

Intervention / Treatment
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* Device: Cochlear implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (Immediate Cochlear Implantation)<br>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. | Device: Cochlear implantation<br>* Unilateral implantation with a commercially approved Nucleus cochlear implant<br>|
| Active Comparator: Group B (Delayed Cochlear Implantation)<br>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. | Device: Cochlear implantation<br>* Unilateral implantation with a commercially approved Nucleus cochlear implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing Handicap | 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. | 6 months after enrollment |