Dexamethasone Eluting Cochlear Implant: a Pivotal Study

NCT06142682 | Recruiting

• 1 other identifier: CDEX2_MED-EL_CRD_2021_01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 7

Brief Summary

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

Cochlear Implant

Keywords

cochlear implantation; CI; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• Change in mean/median speech perception outcome as % correct of speech test in quiet from prior to implantation to the 6-months follow-up with the CIDEXEL

  Speech intelligibility results measured pre-operatively to those measured at the 6-months follow-up.

  6 months visit

Secondary Outcomes (10)

• IFT

  6 months visit

• eCAP

  6 months visit

• Hearing Preservation %

  6 months visit

• HUI 3 (Health Utility Index)

  6 months visit

• NCIQ (Nijmegen Cochlear Implant Questionnaire)

  6 months visit

Study Arms (1)

CIDEXEL

EXPERIMENTAL

MED-EL Cochlear Implant Mi1250 +FLEX28 DEX (CIDEXEL)

Device: Cochlear Implant

Interventions

Cochlear Implant DEVICE

cochlear implantation with dexamethasone eluting electrode

CIDEXEL

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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.

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead

Study Sites (7)

HNO-Klinik der Ruhr-Universität Bochum

Bochum, Germany

RECRUITING

Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde

Dresden, Germany

RECRUITING

Universitätsklinikum Frankfurt Klinik für HNO-Heilkunde

Frankfurt, Germany

RECRUITING

Martin-Luther-Universität Halle-Wittenberg, Universitätsklinik und Poliklinik für Hals-Nasen-OhrenHeilkunde, Kopf- und Hals-Chirurgie

Halle, 06097, Germany

RECRUITING

HNO-Klinik der Medizinischen Hochschule Hannover

Hanover, Germany

RECRUITING

Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde

Tübingen, Germany

RECRUITING

Klinik und Poliklinik für Hals-, Nasen- und Ohrenkrankheiten, plastische und ästhetische Operationen. Die Universitäts-HNO-Klinik Würzburg

Würzburg, Germany

RECRUITING

MeSH Terms

Interventions

Cochlear Implants

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Study Officials

• Stefan Plontke, Prof. Dr.

  Martin-Luther-Universität Halle-Wittenberg, Universitätsklinik und Poliklinik für Hals-Nasen-OhrenHeilkunde, Kopf- und Hals-Chirurgie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Morettini, PhD

CONTACT

+43664607051034; stefano.morettini@medel.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The Cochlear Implant (CI) Mi1250 +FLEX28 DEX (CIDEXEL) is the Investigational Medical Device (IMD) under investigation. MED-EL CI systems consist of an implantable part (i.e. CIDEXEL), external components (i.e. technically compatible audio/speech processor and its accessories) and software that controls and powers the implant. The IMD CIDEXEL will be the implantable part of this new MED-EL CI System and shall only be used together with technically compatible MED-EL external components.

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 21, 2023
• Study Start: September 2, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7)