Dexamethasone-Eluting Cochlear Implant Electrode

  • STATUS
    Recruiting
  • End date
    Oct 1, 2021
  • participants needed
    10
  • sponsor
    MED-EL Elektromedizinische Geräte GesmbH
Updated on 27 January 2021
deafness
cochlear implant
dexamethasone
hearing impairment
AIDS
sensorineural hearing loss
hard of hearing
audiogram
profound sensorineural hearing loss

Summary

A newly developed MED-EL Cochlear Implant 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 a first experience in use of the investigational device in the adult clinical population, and to initially assess tools, techniques and performance outcome measures that may be considered in future clinical studies of similar devices.

Description

The principal objective of this study is to exploratively investigate 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.

The secondary objectives of this study aim at investigating the usefulness of possible outcome measures in evaluating the performance of the device.

Details
Condition Sensorineural hearing loss, Hearing Loss, Auditory Loss and Deafness, Hearing Impairment
Treatment CIDEXEL implant
Clinical Study IdentifierNCT04450290
SponsorMED-EL Elektromedizinische Geräte GesmbH
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Minimum age of eighteen (18) years at time of enrolment
Severe to profound sensorineural hearing loss on the ipsilateral ear
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 (CI) 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

Exclusion Criteria

Lack of compliance with any inclusion criterion
Previously having received a cochlear implant on the ear chosen for placing the IMD (Investigational Medical Device)
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 (Computed Tomography/Magnetic Resonance Tomography)
Evidence of anatomic abnormalities that would prevent appropriate placement of the stimulator housing in the bone of the skull
Evidence of otosclerosis
Known allergic reaction or intolerance to the materials used in the implant (including medical grade silicone, platinum, iridium, parylene c, dexamethasone)
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
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