510(k) K153391

Sophono Bone Conduction Systems (S) Configuration and (M) Configuration by Sophono, Inc. — Product Code LXB

K153391 is an FDA 510(k) premarket notification submitted by Sophono, Inc. for the device "Sophono Bone Conduction Systems (S) Configuration and (M) Configuration". The FDA issued a decision of Substantially Equivalent on June 16, 2016. The device falls under product code LXB (Hearing Aid, Bone Conduction), a Class II device regulated under 21 CFR 874.3302. Sophono, Inc. has at least 4 other 510(k) clearances on record.