Post-market clinical follow-up of a magnetic bone conduction implant (Cochlear Baha® Attract System) - Cochlear

Cochlear Bone Anchored Solutions AB0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•Adult subject, i.e. >= 18 years of age
•Conductive or mixed hearing loss in the ear to be implanted:
•Bone conduction thresholds with a pure tone average PTA4 of < 30 dB hearing level (mean of 500, 1000, 2000 and 4000 Hz).
•Single-sided sensorineural deafness (SSD):
•o European sites: Bone conduction thresholds with a pure tone average PTA4 of < 30dB hearing level (mean of 500, 1000, 2000 and 4000 Hz) in the good ear.
•o US sites: Air conduction thresholds with a pure tone average PTA4 of <= 20 dB hearing level (mean of 500, 1000, 2000 and 3000 Hz) in the good ear OR Subject is indicated for an AC CROS but*for some reason*cannot or will not use an AC CROS.
•No previous bone conduction implant on the side of the skull to be implanted.
•Signed informed consent.

•Subjects that are scheduled for simultaneous bilateral implant surgery. The investigation is limited to subjects with unilateral use of the Baha Attract System (however, bilateral hearing loss is not an exclusion criterion).
•Suitable implant position for the BI300 Implant (4 mm or 3 mm) not found during surgery due to insufficient bone quality and/or bone thickness.
•Less than 3 mm soft tissue thickness at the planned implant site.
•Subjects that have received radiation therapy at the same side of the skull where the Baha Attract System will be positioned.
•Condition that could jeopardise osseointegration and/or wound healing as judged by the investigator (e.g. osteoporosis, psoriasis, use of corticosteroids).
•Uncontrolled diabetes as judged by the investigator.
•Condition that may have an impact on the outcome of the investigation as judged by the investigator.
•Unable to follow investigational procedures (e.g. to complete quality of life scales).
•Participation in another investigation with pharmaceuticals and/or medical device.

发起方