Cochlear implantation for unilateral severe to profound hearing loss

Iwasaki Satoshi0 个研究点目标入组 38 人开始时间: 2021年4月1日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

Iwasaki Satoshi