Hearing Loss in Older Adults Study

ID#: NCT03382769

Age: 65 - 85 years

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Enrolling by invitation

Start Date: March 27, 2019

End Date: February 02, 2022

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.
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
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