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Hearing loss injection study pulled before it began

NCT ID NCT06437054

Disease control Sponsor: Seoul National University Hospital 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 pilot study aimed to test whether a mixture of dexamethasone, hyaluronic acid, and a green dye could be safely injected into the ear to treat certain types of hearing loss that don't improve with standard treatments. The plan was to enroll 26 adults with sudden hearing loss, Meniere's disease, or other inner-ear conditions. However, the study was withdrawn before any participants were enrolled, so no data were collected.

What this could mean

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

Active substance
Dexamethasone, hyaluronic acid, and indocyanine green
What this could lead to
If it had worked, this could point toward a new way to deliver drugs into the ear for stubborn hearing loss.
What could go wrong
The study was withdrawn before it started, so no results exist. Even if it had run, it was a very small pilot—too early to know if the approach would be safe or effective.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

19 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: * Patients with sudden hearing loss, Meniere's disease, ototoxic hearing loss, and noise-induced hearing loss of 25dB HL at the frequency at which hearing loss occurs as a result of pure tone hearing test * Patients whose original hearing ability has not been restored with existing standard treatment (oral, intravenous steroids) * Those who have not participated in clinical trials within 3 months are selected as subjects Exclusion Criteria: * Pregnant or lactating women * When accompanied by lesion, infection, or anatomical deformity of the outer ear, middle ear, or inner ear * Those with liver disease or metabolic disease or a history thereof * History of hypersensitivity to indocyanine green or iodine hypersensitivity * History of ear surgery * Cases with posterior labyrinth lesions * Patients with a history of hypersensitivity to the ingredients of this drug * In addition, serious diseases such as end-stage renal disease, end-stage liver disease, cardiovascular surgery, progressive brain tumor, progressive hemorrhage, and progressive cerebral hemorrhage are included Cases with brain disease and cancer are excluded from the study

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Conditions

The condition(s) this trial relates to.

drug-induced hearing loss Hearing Loss, Sensorineural Meniere disease noise induced hearing loss sensorineural hearing loss disorder sudden sensorineural hearing loss

As listed by the trial registrant

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

Hearing loss, sensorineural Hearing loss, sudden Intratympanic injection

More trials for these conditions

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