Dexamethasone Eluting Cochlear Implant: a Pivotal Study

Launched by MED-EL ELEKTROMEDIZINISCHE GERÄTE GESMBH · Nov 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new type of cochlear implant called the MED-EL Cochlear Implant Mi1250 + FLEX28 DEX, which includes a medication called dexamethasone. This medication is designed to be released gradually after the implant surgery to help reduce inflammation and support healing, particularly addressing issues that can arise from the surgery itself. The goal of the trial is to gather important information about how safe and effective this new implant is for patients.

To participate in the trial, individuals must be at least 18 years old and have hearing loss in one ear where the implant will be placed. They should also have a functioning auditory nerve and have used well-fitted hearing aids for at least three months before considering the implant. Participants will undergo some tests and evaluations to ensure they are suitable for the implant, and they will be closely monitored throughout the study. It’s important for potential participants to understand the eligibility criteria and discuss any concerns with their healthcare provider before enrolling.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • 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.
• • 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.
• • 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.