Hearing Loss in Older Adults Study

Status:	Not yet recruiting
Conditions:	Other Indications, Other Indications, Other Indications
Therapuetic Areas:	Other
Healthy:	No
Age Range:	65 - 85
Updated:	3/27/2019
Start Date:	March 27, 2019
End Date:	February 2, 2022
Contact:	Michelle Knight, B.Sc. Dip.Aud.
Email:	mknight@cochlear.com
Phone:	+61386623110

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

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.

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

We found this trial at

sites

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599

(919) 962-2211