Electric and acoustic stimulation (EAS) type cochlea implantation surgery
Not Applicable
- Conditions
- Bilateral profound sensorineural hearing loss
- Registration Number
- JPRN-UMIN000002778
- Lead Sponsor
- Shinshu University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
The exclusion criteria are as follows: (1)Acute progressive hearing loss (2)autoimmune disease (3)Hearing loss casused by meningitis, otosclerosis and ossification (4)Malformations or obstruction of the cochlea (5)Conductive hearing loss (6)External ear cojtra indications to using amplification devices
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The therapeutic effects are evaluated at 6 month and 12 month after the EAS operation, using the free field audiometry and speech recognition threshold test. In the free field audiometry test, marked recovery is defined as more than 30 dBSPL recovery in the mean hearing level at the 2000Hz, 4000Hz and 8000Hz. In the speech recognition threshold test, marked recovery is defined as any recovery of the maximum speech recognition score (%) by speech recognition threshold test using 67S or 57S Japanese monosirable word tabele (Japan Audiological Society 1967, 1957).
- Secondary Outcome Measures
Name Time Method The secondary outcome are evaluated at 3 month and 6 month after the EAS operation, using pure tone audiometry. In this test, marked effective is defined as less than 40 dBSPL deterioration in the mean hearing level at the 125Hz, 250Hz and 500Hz.