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Cochlear ImplantCDEX2NCT06142682

Dexamethasone Eluting Cochlear Implant: a Pivotal Study

A study testing Cochlear Implant in people with Cochlear Implant, run by MED-EL Elektromedizinische Geräte GmbH at 7 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Cochlear Implant
What is being tested?
Cochlear Implant
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
7 sitesGermany
Study dates
2 Sep 2024to 18 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Germany7 sites

  • HNO-Klinik der Ruhr-Universität Bochum

    Bochum

  • Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde

    Dresden

  • Universitätsklinikum Frankfurt Klinik für HNO-Heilkunde

    Frankfurt

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

    Halle, 06097

  • HNO-Klinik der Medizinischen Hochschule Hannover

    Hanover

  • Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde

    Tübingen

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

    Würzburg

Other trials in Germany

About this study

Official title: Dexamethasone-Eluting Cochlear Implant Electrode (CIDEXEL): Pivotal Study

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.

Read the detailed description

The Cochlear Implant 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.

None of the components mentioned above incorporates, as an integral part transplants or tissues or cells of human or animal origin. No products incorporating or derived from tissues or cells of human or animal origin were used during its manufacturing.

  • Primary Objective

The primary objective of this clinical investigation is to confirm the clinical performance of the CIDEXEL by comparing Speech intelligibility results measured pre-operatively to those measured at the 6-months follow-up.

For this clinical investigation to be successful, mean speech test results at the 6-months visit shall be superior to the mean speech test results obtained pre-operatively. (Monosyllables)

  • Secondary Objectives

The secondary objectives of this clinical investigation are to measure:

  • Impedance Field Telemetry (IFT) values and derived measures
  • Fitting Maps reiteration appraisal
  • Electrically evoked Compound Action Potential (eCAP) and derived measures
  • Unaided audiograms obtained pre- and post-operatively
  • Hearing Preservation (HP) %
  • The improvement in generic quality of life (measured by the Health Utilities Index (HUI2\&3)) pre- to the 6-months visit
  • The improvement in disease specific quality of life (measured by the Nijmegen Cochlear Implant Questionnaire (NCIQ)) pre- to the 6-months visit
  • Surgical Usability and satisfaction (Ad Hoc questionnaire for the surgeons )
  • Sentence test in noise results across the tested intervals (OlSa)
  • Speech, spatial and quality of hearing across the tested intervals (Speech, Spatial and Qualities of hearing scale (SSQ12))
  • Sound quality over time (Hearing Implant Sound Quality Index (HISQUI))
  • Wearing time (data Logging)
  • Safety Objective

The purpose of this clinical investigation is to establish and verify the clinical safety of the CIDEXEL. To confirm the safety profile of the device which will be evaluated through the analysis of adverse events during the follow-up period. For the study to be considered a success, the results of the adverse event analysis shall never cause an unbalanced risk vs. benefit assessment biased towards the former.

Being tested
Cochlear Implant
Keywords
cochlear implantation, CI, Dexamethasone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cochlear ImplantDevice

    cochlear implantation with dexamethasone eluting electrode

Study groups in NCT06142682
Study groupRoleWhat they receive
CIDEXELExperimentalMED-EL Cochlear Implant Mi1250 +FLEX28 DEX (CIDEXEL)
Receives: Device: Cochlear Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months visit

Secondary outcomes (10)

  1. IFT

    Impedance Field Telemetry data in kOhm per channel

    Measured: 6 months visit

  2. eCAP

    Interphase Gap analysis per electrode in charge units

    Measured: 6 months visit

  3. Hearing Preservation %

    Hearing preservation calculated according to the HEARRING HP scale in %

    Measured: 6 months visit

  4. HUI 3 (Health Utility Index)

    Questionnaire outcomes (scale where dead = 0.00 and perfect health = 1.00)

    Measured: 6 months visit

  5. NCIQ (Nijmegen Cochlear Implant Questionnaire)

    Questionnaire outcomes (Physical, Psychological and Social functioning) score 0-100

    Measured: 6 months visit

  6. ad Hoc Surgical questionnaire

    Questionnaire outcomes descriptively apprised

    Measured: 6 months visit

  7. OlSa

    Speech Intelligibility testing outcomes in dB

    Measured: 6 months visit

  8. SSQ12 (Speech Spatial Quality of hearing)

    Questionnaire outcomes Scores 0-10

    Measured: 6 months visit

  9. HISQUI (Hearing Implant Sound Quality Index)

    Questionnaire outcome: very poor sound quality < 30, poor sound quality 30 - 60, moderate sound quality 60 - 90, good sound quality 90 - 110, very good sound quality 110 - 133

    Measured: 6 months visit

  10. Wearing time

    Audio processor wearing time in min

    Measured: 6 months visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2023
  2. Study start2 Sep 2024
  3. Primary completion18 Aug 2026
  4. Study completion18 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06142682
Sponsor's protocol ID
CDEX2_MED-EL_CRD_2021_01
Acronym
CDEX2
Status last verified
Aug 2026
First submitted
7 Nov 2023
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cochlear Implant in people with Cochlear Implant, run by MED-EL Elektromedizinische Geräte GmbH at 7 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 6 months visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06142682.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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