Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array (CI-DEX-LTFU)

Cochlear

Status: Enrolling

Conditions: Bilateral Hearing Loss; Sensorineural Hearing Loss

Treatments: Device: CI632D; Device: CI632

Study type: Observational

Funder types: Industry

Identifiers

NCT06936449

CLTD5759-S1

Details and patient eligibility

About

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.

Enrollment: 19 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

19 participants in 2 patient groups

Experimental: CI632D Investigational Medical Device (IMD)

Description:

Adults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632D cochlear implant

Treatment:

Device: CI632D

Active Comparator: CI632 Comparator Device

Description:

Adults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632 cochlear implant

Treatment:

Device: CI632