Hearing aid or surgery? small study pits both against otosclerosis
NCT ID NCT02456272
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This pilot study from France tested two ways to treat otosclerosis, a condition that causes hearing loss. Thirty people first used a hearing aid for at least two months, then had surgery to fix the middle ear bone. Researchers measured quality of life after each treatment to see which approach works better. The study is small and completed, so it gives early clues but not final answers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hearing aid and otosclerosis surgery
- What this could lead to
- If successful, this study could help doctors and patients choose between hearing aids and surgery for otosclerosis based on quality of life.
- What could go wrong
- This is a small pilot study with only 30 people, so results may not apply to everyone. It compares two treatments but does not prove one is better.
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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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
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30 people
The number who actually took part.
- Start date
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Sep 2015
- Finished
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Dec 2017
- Lead sponsor
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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
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18 years and older
- 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: Nosological criteria: * Unilateral or bilateral asymmetric otosclerosis * Conductive hearing loss of at least 30 dB with an average loss Rinne means greater than or equal to 20 dB (on frequencies 0.5, 1, 2, 4 kHz) * Normal tympanum * Temporal bones CT-scan showing radiologic signs of otosclerosis Related to treatment criteria: • No previous treatment for the otosclerosis Exclusion Criteria: Disease's related criteria: * Far advanced otosclerosis defined as less than 95dB air conduction at all frequencies or lower bone conduction 55dB on at least one frequency * Cochlear otosclerosis objectified on the temporal bones Ct-scan * Others clinical or radiological diagnostics: cholesteatoma, tympanic membrane perforation, geyser's syndrome, ossicular dislocation, ossicular malformation, tympanosclerosis. Associated pathologies: tympanic retraction, effects of chronic otitis, tubal dysfunction. Criteria about proposed treatments: * Anesthesia contraindications * Operative contraindication: clotting disorders, tympanum retraction and tubal dysfunction, geyser's syndrome, single ear, patient refusal. Criteria relative to study's explorations: Language barrier (questionnaires, tests), cognitive disorders. Criteria relating to previous treatment: Previous hearing aid or surgery Administrative criteria: Patients minors, incapable adults, adults under guardianship, incapable of giving consent.
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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.
Contacts and locations
Locations
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Toulouse University Hospital (CHU de Toulouse)
Toulouse, 31059, France
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