Actively Recruiting
Dexamethasone-Eluting Cochlear Implant Electrode (CIDEXEL): Pivotal Study
Led by MED-EL Elektromedizinische Geräte GesmbH · Updated on 2025-08-12
60
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the MED-EL Cochlear Implant Mi1250 +FLEX28 DEX (CIDEXEL), a new cochlear implant device that incorporates the anti-inflammatory drug dexamethasone into its electrode array. This device is designed to reduce post-operative impedance caused by insertion trauma. The main goal is to confirm the safety and performance of this investigational device among patients needing cochlear implantation. The study involves implanting the CIDEXEL device along with compatible external audio and speech processor components. This device does not contain any human or animal tissue-derived materials. The study aims to compare speech intelligibility before implantation and six months after. Secondary measures include impedance telemetry, electrically evoked potentials, hearing preservation, quality of life assessments, surgical usability, speech tests in noise, hearing quality, wearing time, and safety through adverse event monitoring. Participants will be evaluated before implantation and at a six-month follow-up. Assessments include speech perception tests, hearing tests, quality of life questionnaires, and device performance measurements. Safety is tracked by recording any adverse events during follow-up. The total participation includes the implantation procedure and monitoring for at least six months to gather comprehensive data on device performance and safety.
CONDITIONS
Brief Title
Dexamethasone Eluting Cochlear Implant: a Pivotal Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Minimum age of eighteen (18) years at time of enrolment.
- Hearing loss in the ear to be implanted.
- Functional auditory nerve in the ear to be implanted.
- Use of optimally fitted hearing aids for at least three months before deciding on cochlear implantation.
- Cochlea anatomy compatible with FLEX28 electrode insertion.
- Compatibility with a soft surgery approach.
- Post-lingual hearing impairment.
- Meets local professional criteria for cochlear implantation as determined by the implanting surgeon.
- Good general health, psychological and emotional condition suitable for treatment and testing.
- Signed informed consent prior to any study procedures.
You will not qualify if you...
- Failure to meet any inclusion criterion.
- Previous cochlear implant in the ear chosen for this implant.
- Cochlear ossification or anomalies preventing electrode insertion or increasing infection risk.
- Anatomic abnormalities preventing proper placement of the implant housing.
- Known allergy or intolerance to implant materials.
- Absence of cochlear development or non-functioning auditory nerve or pathway.
- Active or recurrent middle or external ear infections in the ear to be implanted.
- Perforated tympanic membrane in the ear to be implanted.
- Use of immunosuppressive or corticosteroid therapy within 4 weeks before enrolment.
- Use of medications that may alter dexamethasone efficacy.
- Inability or unwillingness to comply with study requirements.
- Medical contraindications to ear surgery or anesthesia.
- Additional disabilities preventing participation in evaluations.
- Inability to provide informed consent.
- Subject to court-ordered deprivation of liberty.
- Pregnancy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo implantation of the dexamethasone-eluting cochlear implant device and receive immediate post-surgery care.
1 visit (in-person)
Duration - 6 months
Participants are monitored and evaluated through follow-up visits to assess device performance, hearing outcomes, and safety up to 6 months after surgery.
Multiple visits over 6 months including a key 6-month follow-up visit
Trial Site Locations
Total: 7 locations
1
HNO-Klinik der Ruhr-Universität Bochum
Bochum, Germany
Actively Recruiting
2
Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde
Dresden, Germany
Actively Recruiting
3
Universitätsklinikum Frankfurt Klinik für HNO-Heilkunde
Frankfurt, Germany
Actively Recruiting
4
Martin-Luther-Universität Halle-Wittenberg, Universitätsklinik und Poliklinik für Hals-Nasen-OhrenHeilkunde, Kopf- und Hals-Chirurgie
Halle, Germany, 06097
Actively Recruiting
5
HNO-Klinik der Medizinischen Hochschule Hannover
Hanover, Germany
Actively Recruiting
6
Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde
Tübingen, Germany
Actively Recruiting
7
Klinik und Poliklinik für Hals-, Nasen- und Ohrenkrankheiten, plastische und ästhetische Operationen. Die Universitäts-HNO-Klinik Würzburg
Würzburg, Germany
Actively Recruiting
Research Team
S
Stefano Morettini, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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