Health TrialsbyHealthPanel

Dexamethasone Eluting Cochlear Implant: a Pivotal Study

ConditionCochlear Implant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorMED-EL Elektromedizinische Geräte GesmbH

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Cochlear Implant

    Device

    cochlear implantation with dexamethasone eluting electrode

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: CIDEXELExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
6 months visit

Secondary outcomes

1

IFT

Impedance Field Telemetry data in kOhm per channel

Time frame
6 months visit
2

eCAP

Interphase Gap analysis per electrode in charge units

Time frame
6 months visit
3

Hearing Preservation %

Hearing preservation calculated according to the HEARRING HP scale in %

Time frame
6 months visit
4

HUI 3 (Health Utility Index)

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

Time frame
6 months visit

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MED-EL Elektromedizinische Geräte GesmbH

Lead sponsor

Source ClinicalTrials.gov
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