Dexamethasone Eluting Cochlear Implant: a Pivotal Study

Inclusion Criteria:

Minimum age of eighteen (18) years at time of enrolment.

• Hearing loss on the ipsilateral ear (see Figure 8 for the specific audiologicalcriteria).

• A functional auditory nerve in the ear to be implanted.

• Subjects reporting to having used an optimally fit hearing aids for a minimum ofthree 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 professionalstandards, as reported by the implanting surgeon.

• General health condition, psychological and emotional condition deemed compatiblewith the treatment and tests performed in this study and realistic expectations, asdeemed 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.

• Evidence of ossification or any other cochlear anomaly that might prevent completeinsertion 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 thestimulator 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 isnon-functionality of the auditory nerve and/or the upper auditory pathway.

• Evidence of active external or middle ear infection or history of recurrent middleear 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 4weeks before enrolment.

• Evidence of concomitant use of medicinal substances that, in the opinion of theinvestigator, could alter the therapeutic efficacy of dexamethasone.

• Unwillingness or inability of the candidate to comply with all investigationalrequirements.

• Evidence of medical contraindications to surgery of the middle and inner ear andanaesthesia.

• Additional disabilities that would prevent or restrict participation in theaudiological and medical evaluations required of the clinical investigation.

• Subject not capable of giving consent.

• Individual subjected to court-ordered or government-authorized deprivation ofliberty as defined by § 27 MPDG.

• Evidence of Pregnancy.