Hearing Aid Versus Surgical Rehabilitation as Treatment of Otosclerosis: Pilot Study (PARCO)
Otosclerosis
About this trial
This is an interventional treatment trial for Otosclerosis focused on measuring Otosclerosis, Surgical treatment, Hearing aids
Eligibility Criteria
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.
Sites / Locations
- Toulouse University Hospital (CHU de Toulouse)
Arms of the Study
Arm 1
Experimental
External hearing aid & Otosclerosis surgery
Trying an hearing aid for at least two months and then undergo otosclerosis surgery