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
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
Treatments tested in this trial
- Cochlear Implant
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov