Dexamethasone-Eluting Cochlear Implant Electrode

NCT ID: NCT04450290

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2022-05-05

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.

Detailed Description

The principal objective of this study is to exploratively investigate the safety profile of the device which will be evaluated through the analysis of adverse events during the follow-up period. For the study to be considered a success, the results of the adverse event analysis shall never cause an unbalanced risk vs. benefit assessment.

The secondary objectives of this study aim at investigating the usefulness of possible outcome measures in evaluating the performance of the device.

Conditions

Hearing Loss, Sensorineural; Sensorineural Hearing Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

single arm - treatment

All subjects will be implanted with the investigational device.

Group Type: EXPERIMENTAL

CIDEXEL implant

Intervention Type: 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.

Interventions

CIDEXEL implant

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Lack of compliance with any inclusion criterion.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MED-EL Elektromedizinische Geräte GesmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Hals-Nasen-Ohrenklinik der Medizinischen Hochschule Hannover

Locations

MHH - Medizinische Hochschule Hannover

Hanover, , Germany

Countries

Germany

Other Identifiers

MED-EL_CRD_2014_02

Identifier Type: -

Identifier Source: org_study_id