Hearing Loss in Older Adults Study

Cochlear

Status: Terminated

Conditions: Hearing Loss, Bilateral; Hearing Loss, Sensorineural

Treatments: Device: Cochlear implantation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03382769

CLTD5693

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1 participants in 2 patient groups

Group A (Immediate Cochlear Implantation)

Experimental group

Description:

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.

Treatment:

Device: Cochlear implantation

Group B (Delayed Cochlear Implantation)

Active Comparator group

Description:

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.

Treatment:

Device: Cochlear implantation