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New surgical guide may help cochlear implant patients keep more natural hearing

NCT ID NCT06268340

Disease control Sponsor: Advanced Bionics AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether using a real-time hearing monitoring technique called ECochG during cochlear implant surgery helps preserve natural hearing and inner ear structure better than standard surgery. About 102 adults with severe-to-profound hearing loss will be randomly assigned to either ECochG-guided surgery or routine surgery. The goal is to see if the guidance helps maintain low-frequency hearing and improves speech understanding after the implant.

What this could mean

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

Active substance
electrocochleography (ECochG) monitoring with corrective action guide during cochlear implant surgery
What this could lead to
If successful, this could make cochlear implant surgery more precise, helping preserve natural hearing and improve speech understanding for people with severe hearing loss.
What could go wrong
This is a relatively small, early-stage study (102 participants) comparing two surgical approaches, so results may not apply to all patients. The benefit of ECochG guidance is not yet proven, and surgery always carries risks like infection or device issues.

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

About 102 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

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 years and older

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: * Aged 18 years of age or older * Within cochlear implant inclusion criteria by local regulations/guidelines at the time of implantation * Severe to profound hearing loss (average air conduction unaided hearing threshold of ≥ 70 dB HL for 500, 1000, 2000 and 4000 Hz) in the ear to be implanted * Air conduction unaided hearing threshold ≤ 70 dB HL at 500 Hz in the ear to be implanted * Less than 15 years of severe to profound deafness on the implant ear prior to surgery * Post-lingually acquired hearing loss in the ear to be implanted * Normal cochlear anatomy as confirmed by pre-operative imaging in the ear to be implanted * Listed for an Advanced Bionics HiRes Ultra (3D) HiFocus SlimJ electrode array * Listed for cochlear implant surgery under general anaesthesia * Fluent in local language * Given informed consent to participate in the study Exclusion Criteria: * Abnormal cochlear anatomy (including ossification) as identified by pre-operative radiological evaluation in the ear to be implanted * Any pre-existing cochlear or middle ear pathology, such as otosclerosis, cholesteatoma, or previous middle ear surgery in the ear to be implanted * Any medical conditions that would increase the risk of local complications during cochlear implantation, such as autoimmune diseases or active local infections * Diagnosis of auditory spectrum neuropathy disorder * Deafness due to lesions of the acoustic nerve or central auditory pathway * Deafened by meningitis * Single sided deafness (average for 500, 1000, 2000 and 4000 Hz in the better ear ≤ 30 dB HL) * Asymmetric hearing loss (average for 500, 1000, 2000 and 4000 Hz in the better ear \> 30 dB HL and ≤ 55 dB HL) * History of previous cochlear implantation/re-implantation on either ear * Any contraindications to computed tomography (CT) scans * Concurrent participation in other cochlear implant related studies

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Conditions

The condition(s) this trial relates to.

hearing loss disorder Hearing Loss, Sensorineural sensorineural hearing loss disorder

As listed by the trial registrant

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

Hearing loss, sensorineural Severe to profound hearing loss

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cambridge University Hospitals NHS Foundation Trust

    RECRUITING

    Cambridge, England, CB2 0QQ, United Kingdom

  • Hospital Universitario Clinico San Cecilio

    RECRUITING

    Granada, Granada, 18007, Spain

  • Le Centre Hospitalier Régional Universitaire de Tours

    RECRUITING

    Tours, Tours, 37000, France

  • Ospedale Martini

    RECRUITING

    Torino, TO, 10141, Italy

  • Universitair Ziekenhuis Gent

    RECRUITING

    Ghent, Gent, 9000, Belgium

  • Universitätsklinikum Freiburg Klinik

    RECRUITING

    Freiburg im Breisgau, Freiburg, 79106, Germany

  • World Hearing Center

    RECRUITING

    Warsaw, Nadarzyn, 05-830, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.