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Could an Outer-Ear implant silence ringing that Won't stop?

NCT ID NCT07648615

Symptom relief Sponsor: ENTIC research and training centre of the European Institute for ORL 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a cochlear implant placed just outside the inner ear, near the round window, can safely reduce severe tinnitus that has not responded to standard treatments. Six adults with long-term, high-impact tinnitus will receive the implant in a two-step procedure. Researchers will measure safety, hearing changes, and how much the ringing subsides over 12 months.

What this could mean

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

Active substance
extracochlear electrical stimulation device
What this could lead to
If it works, this could offer a new way to quiet severe tinnitus for people who have not found relief from standard treatments.
What could go wrong
This is a very early feasibility study with only 6 participants, so results may not apply widely. The implant requires surgery and carries risks like hearing loss or infection.

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 6 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Ages

18 to 110 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: * Age ≥ 18 years * Proficient in written and spoken Dutch, defined by self-report or the researcher * Intractable severe/uncompensated unilateral tinnitus, evaluated by VAS-score, and confirmed by Tinnitus functionality Index (TFI) and Tinnitus Questionnaire (TQ) (global TFI score of 54 and above and global TQ-score of 47 and above) * Suffering from tinnitus for at least a year * Not responsive to the normally available clinical tinnitus treatment. * High-frequency sensorineural hearing loss in the ear to be treated * Hearing aid did not provide any tinnitus suppression * Ability to use the device and follow a personalized rehabilitation program. * Ability to undergo the surgery Exclusion Criteria: * Chronic middle ear pathology * Surgical anatomy not allowing for implantation, evaluated by CBCT/MRI imaging * Tinnitus suppression is possible to achieve with hearing aids (as per self-report/documentation) * Clinically significant depression (HADS-score of 11 and above) * Active treatment, or treatment in the past 6 months, with either a chemotherapeutic drug for cancer, or radiation therapy to the head or neck region * Pregnant or breastfeeding women * Current participation in another interventional clinical study/trial in the past 30 days involving an investigational drug or device. * Medical contra-indications to middle ear surgery, and/or anesthesia * Cholesteatoma in the ear to be treated

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Conditions

The condition(s) this trial relates to.

sensorineural hearing loss disorder tinnitus

As listed by the trial registrant

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

Tinnitus

How to take part

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  1. 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 ↗

  2. A doctor treating you

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