Dexamethasone Eluting Cochlear Implant: a Pivotal Study

Recruiting now · Not applicable

Conditions studied: Cochlear Implant

In brief

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.

Key facts

Study ID

NCT06142682

Run by

MED-EL Elektromedizinische Geräte GesmbH

People needed

60

Starts

2024-09-02

Expected to finish

2026-05-30

Last updated by the study team

2025-08-12

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Minimum age of eighteen (18) years at time of enrolment.
• Hearing loss on the ipsilateral ear (see Figure 8 for the specific audiological criteria).
• A functional auditory nerve in the ear to be implanted.
• Subjects reporting to having used an optimally fit hearing aids for a minimum of three months before the decision that a cochlear implant is the preferential option.
• Cochlea anatomy compatible with the insertion of a FLEX28 electrode array.
• Compatibility with a soft surgery approach as per clinical practice at the site.
• Post-lingual hearing impairment.
• Subject fulfilling indication criteria for a CI according to the local professional standards, as reported by the implanting surgeon.
• General health condition, psychological and emotional condition deemed compatible with the treatment and tests performed in this study and realistic expectations, as deemed appropriate by the implanting surgeon.
• Signed and dated informed consent before the start of any study-specific procedure.

You may not qualify if…

• Lack of compliance with any inclusion criterion.
• Previously having received a cochlear implant on the ear chosen for placing the IMD.
• Evidence of ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or might cause increased risk of infection (e.g. dysplastic cochlea), as confirmed by medical examination and/or as per CT/MRT.
• Evidence of anatomic abnormalities that would prevent appropriate placement of the stimulator housing in the bone of the skull.
• Known allergic reaction or intolerance to the materials used in the implant (including medical grade silicone, platinum, iridium, parylene c, DEX).
• Known absence of cochlear development or if the cause of deafness is non-functionality of the auditory nerve and/or the upper auditory pathway.
• Evidence of active external or middle ear infection or history of recurrent middle ear infection in the ear to be implanted.
• Evidence of perforated tympanic membrane in the ear to be implanted.
• Patient reporting immunosuppressive therapy or corticosteroids therapy in the 4 weeks before enrolment.
• Evidence of concomitant use of medicinal substances that, in the opinion of the investigator, could alter the therapeutic efficacy of dexamethasone.
• Unwillingness or inability of the candidate to comply with all investigational requirements.
• Evidence of medical contraindications to surgery of the middle and inner ear and anaesthesia.
• Additional disabilities that would prevent or restrict participation in the audiological and medical evaluations required of the clinical investigation.
• Subject not capable of giving consent.
• Individual subjected to court-ordered or government-authorized deprivation of liberty as defined by § 27 MPDG.
• Evidence of Pregnancy.

Where it is running

• HNO-Klinik der Ruhr-Universität Bochum — Bochum, Germany (enrolling)
• Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde — Dresden, Germany (enrolling)
• Universitätsklinikum Frankfurt Klinik für HNO-Heilkunde — Frankfurt, Germany (enrolling)
• Martin-Luther-Universität Halle-Wittenberg, Universitätsklinik und Poliklinik für Hals-Nasen-OhrenHeilkunde, Kopf- und Hals-Chirurgie — Halle, Germany (enrolling)
• HNO-Klinik der Medizinischen Hochschule Hannover — Hanover, Germany (enrolling)
• Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde — Tübingen, Germany (enrolling)
• Klinik und Poliklinik für Hals-, Nasen- und Ohrenkrankheiten, plastische und ästhetische Operationen. Die Universitäts-HNO-Klinik Würzburg — Würzburg, Germany (enrolling)

Full record on ClinicalTrials.gov

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