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New software could give surgeons a Real-Time view inside the ear during cochlear implant surgery

NCT ID NCT07690995

Knowledge-focused Sponsor: MED-EL Elektromedizinische Geräte GesmbH 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study tests a software tool called OTOGUIDE that helps surgeons monitor the placement of a cochlear implant electrode during surgery. Currently, surgeons lack real-time feedback on where the electrode is inside the cochlea, which can affect hearing outcomes. The trial will check if OTOGUIDE can accurately detect which electrodes are inserted and estimate their angle, comparing results to CT scans. Participants are adults receiving a compatible MED-EL cochlear implant.

What this could mean

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

Active substance
OTOGUIDE software
What this could lead to
If successful, OTOGUIDE could give surgeons real-time feedback during cochlear implant surgery, potentially improving electrode placement accuracy and hearing results for patients.
What could go wrong
This is a small, early-stage study focused on accuracy compared to CT scans, not on long-term hearing improvement. The software may not work as well in all patients or surgical conditions.

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 42 people

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

Started

Aug 2026

Expected to finish

Feb 2028

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: * Minimum age of eighteen (18) years at time of enrolment. * Subjects to be implanted with a compatible MED-EL cochlear implant (CI) (Mi1200 SYNCHRONY (PIN), Mi1210 SYNCHRONY ST, Mi1250 SYNCHRONY 2 (PIN), Mi1260 SONATA 2) according to clinical routine. * Signed and dated informed consent before the start of any study-specific procedure. Exclusion Criteria: * Previously having received a CI on the ear to be tested (Re-implantation). * Evidence of ossification or any other cochlear anomaly (e.g., malformation) that might prevent complete insertion of the electrode array or might cause increased risk of infection (e.g. dysplastic cochlear), as confirmed by medical examination and/or as per CT/MRI. * 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. * Acute cholesteatoma * The tympanic membrane is perforated in the ear to be implanted. * Pre-existing condition known to prohibit CT imaging before and after cochlear implantation. * Women being pregnant or nursing. * Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.

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Conditions

The condition(s) this trial relates to.

hearing loss disorder

As listed by the trial registrant

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

Cochlear implantation Monitoring electrode insertion

How to take part

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

  1. The places running it

    2 sites in 2 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

  • Klinikum der Universität München, Campus Großhadern Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde

    NOT_YET_RECRUITING

    Munich, Bavaria, 81377, Germany

  • Medizinische Universität Innsbruck

    RECRUITING

    Innsbruck, Tyrol, 6020, Austria

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