Hearing Loss in Older Adults Study

Cochlear1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hearing Loss, Sensorineural Hearing Loss, Bilateral

Interventions

Cochlear implantationDEVICE

Unilateral implantation with a commercially approved Nucleus cochlear implant

Eligibility

Sex: ALLMin age: 65 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (8)

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

Outcomes

Primary Outcomes

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.

Time frame: 6 months after enrollment

Data from ClinicalTrials.gov

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