Clinical performance of a new implant system for bone conduction hearing - CBAS5539

Cochlear Bone Anchored Solutions AB0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•* Adult subjects (18 years or older)
•* Subject with conductive or mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of <<= 55 dB.
•Subject with single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure tone average PTA4 of <<= 20 dB HL (mean of 0.5, 1, 2 and 3 kHz) in the good ear
•Subject who is indicated for an AC CROS but*for some reason*cannot or will not use an AC CROS (Air Conduction-Contralateral Routing of Signal).
•* Signed informed consent
•* Previous experience from amplified sound though properly fitted amplication. (For example but not limited to Hearing aid, CROS device, Bone conductional hearing device on headband/ softband)

•* Uncontrolled diabetes as judged by the investigator.
•* Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator.
•* Insufficient bone quality and quantity for implantation of a BI300 Implant.
•* Subject that has received radiotherapy in the area of implantation, or is planned for such radiotherapy during the study period.
•* Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator.
•* Unable to follow investigational procedures, e.g. to complete quality of life scales.
•* Participation in another clinical investigation with pharmaceutical and/or device.
•* The subject is pregnant or lactating
•* The subject suffers from psychiatric and/or psychomatic disorder(s)

发起方