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Performance and Hearing-related Outcomes in Adults Implanted With the CI622D Dexamethasone-eluting Cochlear Implant Compared to Those Implanted With a Standard Cochlear Implant (CI622)

NCT06424262 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-02-27

No results posted yet for this study

Summary

This clinical study will test a newly developed cochlear implant known as CI622D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone. Dexamethasone works to ease inflammation, which is common after any surgical procedure. The goal is to learn if there are added benefits in implant performance and hearing outcomes with the dexamethasone-releasing cochlear implant (CI622D) vs. the standard cochlear implant (CI622) without dexamethasone. The study will be conducted in adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve. The study participants will undergo a series of tests that include testing their implant and their hearing. They will also complete questionnaires to see how they rate their hearing ability and their overall general health.

Conditions

  • Hearing Loss, Bilateral Sensorineural
  • Hearing Loss, Sensorineural
  • Hearing Loss, Bilateral
  • Hearing Loss, Cochlear

Interventions

DEVICE

CI622D

A dexamethasone-eluting Slim Straight electrode

DEVICE

CI622

A standard Slim Straight electrode

Sponsors & Collaborators

  • QbD Clinical

    collaborator INDUSTRY

  • Avania

    collaborator INDUSTRY

  • Cochlear

    lead INDUSTRY

Principal Investigators

  • Antje Aschendorff · Universitätsklinikum Freiburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-17
Primary Completion
2025-11-05
Completion
2026-05-31

Countries

  • Australia
  • France
  • Germany
  • United Kingdom

Study Locations

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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 NCT06424262 on ClinicalTrials.gov