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New cochlear implants show promise for severe hearing loss

NCT ID NCT04610112

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested two types of cochlear implants in 30 adults with severe-to-profound hearing loss who had never used an implant before. The goal was to see if the devices are safe and help people understand speech better in quiet and noisy settings. Participants received the implant as part of routine care and were followed to measure their hearing improvements.

What this could mean

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

Active substance
cochlear implant (HiRes Ultra and HiRes Ultra 3D with HiFocus MS electrode)
What this could lead to
If successful, this could confirm that these implants are safe and help improve speech understanding for people with severe hearing loss.
What could go wrong
This is a small, completed study focused on safety and performance, not a cure. Results may not apply to all hearing loss types or guarantee long-term benefit.

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.

Participants

30 people

The number who actually took part.

Started

Sep 2020

Finished

May 2025

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.

Who is studied

30 adult subjects with valid and useable data

Ages

18 years and older

Sex

Anyone

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: * No previous experience with any auditory implant * 18 years of age or older * Postlingual onset of severe hearing loss (≥ 4 years of age) * Limited benefit from appropriately fitted hearing aids, defined as scoring 60% or less in Freiburger Monosyllabic word test * German language proficiency * Willingness to participate in all scheduled procedures outlined in the protocol Exclusion Criteria: * Cochlear malformation or obstruction that would preclude full insertion of electrode array. * Presence of additional disabilities that would prevent or interfere with participation in the required study procedures * Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures * Evidence of central auditory lesion or compromised auditory nerve * Pregnancy at time of surgery.

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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.

Cochlear hearing loss

Contacts and locations

Locations

  • Heilig Geist Hospital Bensheim

    Bensheim, Hesse, 64625, Germany

  • Klinik für HNO-Heilkunde. Kopf- imd Halschirurgie

    Mannheim, 68167, Germany

  • Unfallkrankenhaus Berlin (UKB

    Berlin, State of Berlin, 12683, Germany

More trials for these conditions

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