Clinical research of the bone conductive hearing system.

未提供0 个研究点目标入组 5 人开始时间: 2018年7月11日最近更新: 2021年11月19日

试验速览

暂无简介。

•General inclusion criteria
•Written informed consent was obtained from patient (or their guardians if they are minor).
•The age of informed consent was 5 years old or above.
•Audiometric inclusion criteria
•Unilateral or bilateral conductive hearing loss or mixed hearing loss.
•Patient affected ear fulfill the below bone conduction hearing thresholds.
•The patients with bone conducting hearing thresholds in 500Hz to 4000Hz is under 45dBHL.

•(1)The patients with severe bone malformation and did not have enough setting space for bone conductive implantation.
•(2)The patients with un-compatible to general anesthesia.
•(3)The Patients with post cochlear hearing loss.
•(4)The patients with skin problem and did not ware audio processor.
•(5)The patients who assessed unsuitable for this clinical research from medical doctor.

free field audiometry

时间窗: 6 month after the BONEBRIDGE operation

In this test, marked recovery is defined as any recovery in the mean hearing level at the 500, 1000, 2000 and 4000Hz

发起方

未提供