Can a Drug-Releasing electrode make cochlear implants work better?

NCT ID NCT06142682

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This trial tests a new type of cochlear implant electrode that slowly releases dexamethasone, an anti-inflammatory drug, to reduce the trauma of insertion and improve hearing outcomes. The study involves adults with hearing loss who are candidates for cochlear implantation. Researchers will measure speech perception before and six months after implantation, along with other safety and performance measures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A cochlear implant with an electrode that slowly releases the anti-inflammatory drug dexamethasone
What this could lead to
If successful, this could improve hearing outcomes for cochlear implant recipients by reducing post-surgical inflammation and preserving residual hearing.
What could go wrong
This is a pivotal study with a relatively small number of participants, and results may not confirm safety or performance. Risks include surgical complications and potential adverse effects from the drug-eluting electrode.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

59 people

The number who actually took part.

Started

Sep 2024

Finished

Aug 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • HNO-Klinik der Medizinischen Hochschule Hannover

    Hanover, Germany

  • HNO-Klinik der Ruhr-Universität Bochum

    Bochum, Germany

  • Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde

    Dresden, Germany

  • Klinik und Poliklinik für Hals-, Nasen- und Ohrenkrankheiten, plastische und ästhetische Operationen. Die Universitäts-HNO-Klinik Würzburg

    Würzburg, Germany

  • Martin-Luther-Universität Halle-Wittenberg, Universitätsklinik und Poliklinik für Hals-Nasen-OhrenHeilkunde, Kopf- und Hals-Chirurgie

    Halle, 06097, Germany

  • Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde

    Tübingen, Germany

  • Universitätsklinikum Frankfurt Klinik für HNO-Heilkunde

    Frankfurt, Germany

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