Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array

Description

A long-term follow-up of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.

Conditions

Sensorineural Hearing Loss, Bilateral Hearing Loss

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Study Overview

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Study Details

Study overview

A long-term follow-up of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.

Long-term Follow-up of a Cohort of Adult CI632D and CI632 Participants in the CLTD5759 CI-DEX Study

Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array

Condition
Sensorineural Hearing Loss
Intervention / Treatment

-

Contacts and Locations

Englewood

Rocky Mountain Ear Center, Englewood, Colorado, United States, 80113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Subjects who completed study obligations of the CLTD5759 CI-DEX study and enrolled at a site selected for participation.
  • * Subjects implanted with a CI632D or a CI632 cochlear implant under the CLTD5759 (NCT04750642).
  • * Willing and able to provide written informed consent.
  • * Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to participation as determined by the Investigator.
  • * Additional disabilities that may affect the subject's participation or safety during the clinical investigation.
  • * Unable or unwilling to comply with all the requirements of the clinical investigation as determined by the Investigator.
  • * Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cochlear,

Study Record Dates

2028-03