Cochlear implant with dexamethasone for improved hearing outcomes

Dexamethasone-Eluting Cochlear Implant Electrode (CIDEXEL): Pivotal Study

This study is testing a new cochlear implant that includes a medication to see if it helps adults with certain types of hearing loss hear better after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: MED-EL Elektromedizinische Geräte GesmbH (Industry-sponsored)
• Locations: 7 sites (Bochum and 6 other locations)
• Trial ID: NCT06142682 on ClinicalTrials.gov

What this trial studies

This clinical investigation evaluates the MED-EL Cochlear Implant Mi1250 +FLEX28 DEX, which incorporates dexamethasone to reduce post-operative inflammation and improve hearing outcomes. The study aims to confirm the device's safety and performance by comparing speech intelligibility results before and six months after implantation. Participants will undergo various assessments, including impedance telemetry and audiograms, to gather comprehensive data on the device's effectiveness. The study is designed for adults with specific hearing loss criteria who have previously used hearing aids.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with post-lingual hearing impairment and a functional auditory nerve who have used hearing aids for at least three months.

Not a fit: Patients with non-functional auditory nerves or those who do not meet the specific audiological criteria for cochlear implantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance speech understanding and overall hearing performance for cochlear implant recipients.

How similar studies have performed: While the use of dexamethasone in cochlear implants is a novel approach, similar studies have shown promise in reducing inflammation and improving outcomes in other surgical contexts.

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.

Where this trial is running

Bochum and 6 other locations

• HNO-Klinik der Ruhr-Universität Bochum — Bochum, Germany (Recruiting)
• Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde — Dresden, Germany (Recruiting)
• Universitätsklinikum Frankfurt Klinik für HNO-Heilkunde — Frankfurt, Germany (Recruiting)
• Martin-Luther-Universität Halle-Wittenberg, Universitätsklinik und Poliklinik für Hals-Nasen-OhrenHeilkunde, Kopf- und Hals-Chirurgie — Halle, Germany (Recruiting)
• HNO-Klinik der Medizinischen Hochschule Hannover — Hanover, Germany (Recruiting)
• Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde — Tübingen, Germany (Recruiting)
• Klinik und Poliklinik für Hals-, Nasen- und Ohrenkrankheiten, plastische und ästhetische Operationen. Die Universitäts-HNO-Klinik Würzburg — Würzburg, Germany (Recruiting)

Study contacts

• Principal investigator: Stefan Plontke, Prof. Dr. — Martin-Luther-Universität Halle-Wittenberg, Universitätsklinik und Poliklinik für Hals-Nasen-OhrenHeilkunde, Kopf- und Hals-Chirurgie
• Study coordinator: Stefano Morettini, PhD

Conditions Cochlear Implant; cochlear implantation; CI; Dexamethasone