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.
Otosclerosis is the main cause of acquired hearing loss in young to middle aged Caucasian population. Social, personal and medico-economic impacts triggered by this affection make it a major public health matter. Historically, the surgical treatment of otosclerosis has always been considered one of the best indications of otologic surgery. The external hearing aid was then an alternative to surgery considered as a more restrictive and less effective management of otosclerosis. With the recent technological developments of hearing aids, comparing these two treatments otosclerosis should be studied. The absence of scientific data from the literature concerning this subject justifies this study which purpose is to describe the evolution of the quality of life and hearing performance of a same patient after taking over by these two approaches. 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. The primary outcome will be based on a study of the quality of life (score of 0-100 to quality of life validated questionnaire Glasgow Health Status Inventory (GHSI)). The questionnaire will be given to the patient at the pre-enrollment visit, after a period of two months of external hearing aid trying and 2 months after the surgery. Secondary outcomes will be studied: simple hearing performance (voice and tone audiogram), complex hearing performance (speech audiogram in noise recognition stamp), specific questionnaires for hearing (SSQ), for hearing aids (APHAB, GBI equipment), for tinnitus if present (THI and VAS discomfort / intensity) or for surgical treatment (surgery GBI). Data about treatment's side effects and the number of potential patients refusing surgery after testing the hearing aid will also be collected.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The external hearing aid (monaural) with an auditory prosthesis contour type, brand PHONAK type Bolero Q70 will be provided to the patients during a minimum of 2 months.For reasons of standardization and comparability of results, only one type of prosthesis (medium-high range) will be provided. The settings will be performed by audiologists of ENT service during the inclusion visit.
Surgical restoration of the columellar effect consists of the intraoperative verification of the stapedo-vestibular ankylosis which provides diagnostic. Then a stapedotomy (laser or Ototool°) is performed and partial ossicular prosthesis s inserted between stapedotomy and the long process of the incus.
Toulouse University Hospital (CHU de Toulouse)
Toulouse, France
Evolution of the quality of life (scored by GHSI)
The primary outcome is to describe the evolution of the quality of life (scored by the Glasgow Health Status Inventory (GHSI)) during the hearing rehabilitation of otosclerosis frst with an external monaural hearing aid (support for at least 2 months), followed by a surgical treatment.
Time frame: 4th Month
Evolution of the quality of life (scored by SSQ)
Secondary outcomes will be to describe the evolution of the quality of life by specific questionnaires (SSQ APHAB, GBI), the evolution of simple and complex audiometric testing in both managements of otosclerosis. Adverse reactions reported are also analyzed as well as the number of patients refusing surgery after trying hearing aid rehabilitation.
Time frame: Change and evolution at different time points: baseline, 2-month intervention, 2-month after surgery
Evolution of the quality of life (scored by APHAB)
Secondary outcomes will be to describe the evolution of the quality of life by specific questionnaires (SSQ APHAB, GBI), the evolution of simple and complex audiometric testing in both managements of otosclerosis. Adverse reactions reported are also analyzed as well as the number of patients refusing surgery after trying hearing aid rehabilitation.
Time frame: Change and evolution at different time points: baseline, 2-month intervention, 2-month after surgery
Evolution of the quality of life (scored by GBI)
Secondary outcomes will be to describe the evolution of the quality of life by specific questionnaires (SSQ APHAB, GBI), the evolution of simple and complex audiometric testing in both managements of otosclerosis. Adverse reactions reported are also analyzed as well as the number of patients refusing surgery after trying hearing aid rehabilitation.
Time frame: Change and evolution at different time points: baseline, 2-month intervention, 2-month after surgery
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