Cochlear*s Direct Acoustic Cochlear Stimulator Investigational Device (C-DACS ID) clinical trial CAG5229 - C-DACS clinical trial CAG5229

Cochlear AG0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•1. Eighteen years of age or older
•2. Mixed severe to profound hearing loss
•3. Conductive hearing loss is a result of otosclerosis or prior failed stapes surgery
•4. Bone conduction thresholds are worse than 40 dB HL on at least 3 out of 5 frequencies (500 Hz, 1 kHz, 2 kHz, 3 kHz and 4 kHz) but must be measurable at all five frequencies
•5. Bone conduction thresholds equal to or greater than 30 dB HL in all frequencies
•6. Air-bone gap equal to or greater than 30 dB HL on at least 3 out of 5 frequencies
•7. Bone conduction of contra-lateral ear is equal to or worse than 30 dB HL at the best frequency

•1. Participation in another medical device study
•2. Unwillingness or inability of the subject to comply with all study requirements
•3. Bone conduction threshold exceeds 80 dB HL at 1 or more out of 5 frequencies (500 Hz, 1 kHz, 2 kHz, 3 kHz and 4 kHz)
•4. Air conduction threshold exceeds 120 dB HL at 1 or more out of 5 frequencies
•(500 Hz, 1 kHz, 2 kHz, 3 kHz and 4 kHz)
•5. Medical or psychological conditions that would contraindicate undergoing surgery
•6. Sudden hearing loss
•7. Disabling tinnitus
•8. Insufficient mastoid and/or ear canal size (to be checked on CT scan)
•9. Other criteria at investigator*s discretion

发起方

Cochlear AG