510(k) K153245

Baha 5 Super Power Sound Processor by Cochlear Americas — Product Code LXB

K153245 is an FDA 510(k) premarket notification submitted by Cochlear Americas for the device "Baha 5 Super Power Sound Processor". The FDA issued a decision of Substantially Equivalent on March 2, 2016. The device falls under product code LXB (Hearing Aid, Bone Conduction), a Class II device regulated under 21 CFR 874.3302. Cochlear Americas has at least 10 other 510(k) clearances on record.