Long-term follow-up of a cochlear implant with a drug-eluting electrode

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study involves a long-term follow-up of patients who have received a cochlear implant with a dexamethasone-eluting electrode array. The aim is to observe the effects of the implant on sensorineural and bilateral hearing loss over time, particularly focusing on the reduction of inflammatory responses due to the drug elution. Participants must have previously completed obligations of a related study and be willing to provide informed consent. The study is observational and does not involve new interventions.

Why it matters

Who can join: the full rules

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.

Where it's running

• Rocky Mountain Ear Center
  Englewood, Colorado, United States Recruiting
• University of Iowa
  Iowa City, Iowa, United States Recruiting
• University Hospitals Cleveland
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: PRS Specialist
• Email: cltd-prs-admin@cochlear.com
• Phone: +61 2 9428 6555

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.