Dexamethasone-Eluting Cochlear Implant Electrode

NCT04450290 | Completed

• 1 other identifier: MED-EL_CRD_2014_02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hearing Loss, Sensorineural; Sensorineural Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Safety profile of the device which will be evaluated through the analysis of adverse events

  10 months

Secondary Outcomes (8)

• IFT (Impedance Field Telemetry) - impedance

  10 months

• Electrically Evoked Compound Action Potential

  10 months

• MCL (Maximum Comfortable Loudness)

  10 months

• THR (Threshold)

  10 months

• PTA (Pure Tone Audiometry) Audiometrical values

  10 months

Study Arms (1)

single arm - treatment

EXPERIMENTAL

All subjects will be implanted with the investigational device.

Device: CIDEXEL implant

Interventions

CIDEXEL implant DEVICE

The 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.

single arm - treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead

Study Sites (1)

MHH - Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Lenarz, Prof. Prof. h. c. Dr. med.

  Hals-Nasen-Ohrenklinik der Medizinischen Hochschule Hannover

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: First-in-human, single-arm, exploratory, open-label, prospective, longitudinal, monocentric study

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 29, 2020
• Study Start: June 30, 2020
• Primary Completion: May 5, 2022
• Study Completion: May 5, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

DE (1)