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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion 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.

Exclusion Criteria

  • 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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Experimental: CI632D Investigational Medical Device (IMD) Adults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632D cochlear implant
  • Device: CI632D
    CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells
Active Comparator: CI632 Comparator Device Adults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632 cochlear implant
  • Device: CI632
    CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone

Recruiting Locations

Rocky Mountain Ear Center
Englewood, Colorado 80113
Contact:
Aaron Parkinson
800 523 5798
aparkinson@cochlear.com

University of Iowa
Iowa City, Iowa 52242
Contact:
Aaron Parkinson
800 523 5798
aparkinson@cochlear.com

University Hospitals Cleveland
Cleveland, Ohio 44106
Contact:
Aaron Parkinson
800 523 5798
aparkinson@cochlear.com

More Details

Status
Recruiting
Sponsor
Cochlear

Study Contact

PRS Specialist
+61 2 9428 6555
cltd-prs-admin@cochlear.com