Hearing Aid Versus Surgical Rehabilitation as Treatment of Otosclerosis: Pilot Study (NCT02456272) | Clinical Trial Compass
CompletedNot Applicable
Hearing Aid Versus Surgical Rehabilitation as Treatment of Otosclerosis: Pilot Study
France30 participantsStarted 2015-09
Plain-language summary
This is a French pilot study in the Toulouse University Hospital that will include a minimum of 30 patients with proven unilateral or asymmetric otosclerosis. Each one will receive a hearing aid for a minimum of 2 months and then undergo otosclerosis surgery.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.