Benefits of the HiResolutionTM Bionic Ear System in Adults with Low-Frequency Hearing. - AB-RCA-01-13

Advanced Bionics Corporation0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年8月12日

适应症

试验速览

暂无简介。

•18 years of age or older
•Definite Postlingual onset of severe-to-profound hearing loss as documented by completing main stream primary education
•Preferably, aided mono- or bisyllabic word score of >= 15 % at 65 dB SPL in quiet in the ear to be implanted
•Local language proficiency
•Bilateral, sensorineural hearing loss of a mild to moderate degree in the low frequencies and a severe or a greater degree of hearing loss in the mid-to-high frequencies, defined as pure-tone thresholds (PT):
•- PT <= 60 dB HL at 250, 500, and 750 Hz BUT at one of these 3
•frequencies a value <= 70 dB is acceptable
•- PT >= 70 dB HL at 2000, 4000, and 8000 Hz
•Contralateral ear PTA ± 30 dB HL at 250, 500, 750 and 1000 Hz as compared to the ear to be implanted

•Previous inner or major middle ear surgery or active middle ear pathology.
•Cochlear malformation or obstruction as confirmed by pre OP MRI (an MRI is required to exclude obstruction when history indicates a higher risk for obstructions)
•Presence of additional disabilities that would prevent or interfere with participation in the required study procedures
•Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study-related procedures
•Evidence of central auditory lesion or compromised auditory nerve
•Concurrent participation in other study

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