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Hearing Loss in Older Adults Study

NCT03382769 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-12-22

Study results available
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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.

Conditions

  • Hearing Loss, Sensorineural
  • Hearing Loss, Bilateral

Interventions

DEVICE

Cochlear implantation

Unilateral implantation with a commercially approved Nucleus cochlear implant

Sponsors & Collaborators

  • CogState Ltd.

    collaborator INDUSTRY

  • Syneos Health

    collaborator OTHER

  • Cochlear

    lead INDUSTRY

Principal Investigators

  • David N Cade, MD, MBA · Cochlear

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-27
Primary Completion
2020-01-04
Completion
2020-01-04
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03382769 on ClinicalTrials.gov