Hearing Loss in Older Adults Study

Not Applicable

Terminated

• Conditions: Hearing Loss, Bilateral; Hearing Loss, Sensorineural

• Registration Number: NCT03382769
• Lead Sponsor: Cochlear

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2017-12-19
• Study First Posted: 2017-12-26
• Study Start: 2019-03-27
• Primary Completion: 2020-01-04
• Study Completion: 2020-01-04
• Results First Submitted: 2022-09-13
• Status Verified: 2022-11
• Results First Submitted QC: 2022-11-30
• Last Update Submitted: 2022-11-30
• Results First Posted: 2022-12-22
• Last Update Posted: 2022-12-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hearing Handicap	6 months after enrollment	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.

Trial Locations

Locations (8)

Arizona Center for Neurosciences; 🇺🇸 Tucson, Arizona, United States

House Ear Institute; 🇺🇸 Los Angeles, California, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

New York Eye and Ear Infirmary of Mount Sinai; 🇺🇸 New York, New York, United States

University of North Carolina Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

University of Cincinnati Health; 🇺🇸 Cincinnati, Ohio, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States