Actively Recruiting
Dexamethasone Eluting Cochlear Implant: a Pivotal Study
Led by MED-EL Elektromedizinische Geräte GesmbH · Updated on 2025-08-12
60
Participants Needed
7
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The newly developed MED-EL Cochlear Implant Mi1250 +FLEX28 DEX (CIDEXEL) incorporates the anti-inflammatory agent dexamethasone (DEX) into the electrode array. The passive elution of DEX during the post-implantation period has the purpose of counteracting the increase of the post-operative impedance induced by the insertion trauma. The aim of this clinical investigation is to obtain confirmatory data concerning safety and performances of the investigational device in the clinical population.
CONDITIONS
Official Title
Dexamethasone Eluting Cochlear Implant: a Pivotal Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Minimum age of eighteen (18) years at time of enrolment.
- Hearing loss on the ear to be implanted.
- Functional auditory nerve in the ear to be implanted.
- Use of optimally fitted hearing aids for at least three months before deciding on cochlear implantation.
- Cochlea anatomy suitable for insertion of a FLEX28 electrode array.
- Compatibility with a soft surgery approach as per clinical practice.
- Post-lingual hearing impairment.
- Meeting local professional criteria for cochlear implantation as determined by the implanting surgeon.
- General health, psychological, and emotional condition compatible with treatment and study tests as assessed by the implanting surgeon.
- Signed and dated informed consent before any study procedures.
You will not qualify if you...
- Failure to meet any inclusion criterion.
- Prior cochlear implant in the ear selected for implantation.
- Cochlear ossification or anomalies preventing electrode insertion or increasing infection risk.
- Anatomical abnormalities preventing placement of the stimulator housing in the skull bone.
- Known allergy or intolerance to implant materials including silicone, platinum, iridium, parylene c, or dexamethasone.
- Absence of cochlear development or non-functionality of auditory nerve or upper auditory pathway.
- Active or recurrent middle or external ear infections in the ear to be implanted.
- Perforated eardrum in the ear to be implanted.
- Immunosuppressive or corticosteroid therapy within 4 weeks before enrollment.
- Use of medications that could affect dexamethasone efficacy as judged by the investigator.
- Inability or unwillingness to comply with study requirements.
- Medical contraindications to middle/inner ear surgery or anesthesia.
- Disabilities preventing participation in audiological or medical evaluations.
- Inability to give informed consent.
- Legal deprivation of liberty.
- Pregnancy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
HNO-Klinik der Ruhr-Universität Bochum
Bochum, Germany
Actively Recruiting
2
Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde
Dresden, Germany
Actively Recruiting
3
Universitätsklinikum Frankfurt Klinik für HNO-Heilkunde
Frankfurt, Germany
Actively Recruiting
4
Martin-Luther-Universität Halle-Wittenberg, Universitätsklinik und Poliklinik für Hals-Nasen-OhrenHeilkunde, Kopf- und Hals-Chirurgie
Halle, Germany, 06097
Actively Recruiting
5
HNO-Klinik der Medizinischen Hochschule Hannover
Hanover, Germany
Actively Recruiting
6
Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde
Tübingen, Germany
Actively Recruiting
7
Klinik und Poliklinik für Hals-, Nasen- und Ohrenkrankheiten, plastische und ästhetische Operationen. Die Universitäts-HNO-Klinik Würzburg
Würzburg, Germany
Actively Recruiting
Research Team
S
Stefano Morettini, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here