Can a steroid injection into the ear beat oral pills for sudden hearing loss?
NCT ID NCT06968507
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
This trial tests two standard steroid treatments for sudden sensorineural hearing loss, a condition where hearing drops quickly, often in one ear. One group takes methylprednisolone pills daily for two weeks, while the other receives dexamethasone injections into the middle ear every other day for four doses. Researchers compare hearing tests at two months to see which approach restores more hearing. The study includes adults with recent hearing loss and follows them with checkups over two months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Methylprednisolone (oral) and dexamethasone (intratympanic injection)
- What this could lead to
- If one treatment proves more effective, it could become the preferred standard for sudden hearing loss, potentially improving hearing recovery for many patients.
- What could go wrong
- The trial is at one hospital and results may not apply to everyone. Hearing recovery varies, and steroids carry risks like elevated blood sugar, stomach irritation, or injection-related discomfort.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 214 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * 18 years of age and older * Unilateral sudden sensorineural hearing loss that developed within 72 hours and has lasted for 14 days or less * Affected side PTA (500-100-2000-4000hz) should be over 50dB * Affected side should be at least 30dB lower than healthy side in 3 frequencies * Hearing should be symmetrical according to patient's statement before sensorineural hearing loss * If used, steroid use should be less than 10 days * Cerebellar and vestibular examination should be normal Exclusion Criteria: * Having a history of hearing-related surgery other than a ventilation tube * Having a history of previous hearing loss, fluctuating hearing or Meniere's disease, chronic inflammatory or suppurative ear disease or cholesteatoma, otosclerosis * Being under 18 or over 80 * Having a history of physical-barotrauma * Presence of structural or retrocochlear pathology in the examination and imaging that would explain the unilateral hearing loss * Patients diagnosed with tuberculosis or receiving prophylactic tuberculosis treatment, diabetes mellitus, rheumatological patients, those with atherosclerotic disease, serious psychiatric patients, those receiving chemotherapy, radiotherapy or immunosuppressant treatment, pancreatitis patients, HIV, hepatitis C and B patients, those with chronic renal failure, substance abusers, those with active herpetic lesions, severe osteoporosis patients, those with hearing loss within 4 weeks after general anesthesia, those with a history of head and neck cancer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Dr Lütfi Kırdar City Hospital
RECRUITINGIstanbul, Kartal, 34865, Turkey (Türkiye)
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