JPRN-jRCTs032200430
Recruiting
Phase 3
Cochlear implantation for unilateral severe to profound hearing loss
Iwasaki Satoshi0 sites38 target enrollmentApril 1, 2021
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- nilateral severe to profound sensorineural hearing loss
- Sponsor
- Iwasaki Satoshi
- Enrollment
- 38
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •General criteria
- •(1\) Patient agreed to participate in the study and signed to the informed consent document.
- •(if patient is a monor, patiens or legal guardians sign to the informed consent document.)
- •(2\) Age of 6 years or older when agreed.
- •Audiological criteria
- •(1\) The patient withbpost\-lingual onset unilateral severe to profound sensorineural hearing loss.
- •(2\) The pure tone average (500Hz, 1000Hz, 2000Hz, and 4000Hz) of affected side was 70dBHL or more, or 30% or less speech perception score in affected ear with hearing aid.
- •(3\) The onset of hearing loss was 6 months or more and expect the insufficient improvement of hearing ability by conventional treatment.
- •(4\) The pure tone average (500Hz, 1000Hz, 2000Hz, and 4000Hz) of contralateral side was 40dBHL oe less.
Exclusion Criteria
- •The patients with below situations were exclude from this study.
- •(1\) Hearing recovery was observed in past 6 month greater than 15dB.
- •(2\) Cochear ossification in patients with hearing loss (meningitis, otosclerosis).
- •(3\) Severe malformation and cochlear obstraction.
- •(4\) Severe outer ear malformation and does not wear audioprosessor.
- •(5\) High risk for general anesthesia.
- •(6\) Active middle eat infection.
- •(7\) Clearly evidenced retro\-labryinthine hearing loss adult.
- •(8\) Severe mental retardation adult.
Outcomes
Primary Outcomes
Not specified
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