510(k) K100193

OTOMAG BONE CONDUCTION HEARING SYSTEM by Sophono, Inc. — Product Code LXB

K100193 is an FDA 510(k) premarket notification submitted by Sophono, Inc. for the device "OTOMAG BONE CONDUCTION HEARING SYSTEM". The FDA issued a decision of Substantially Equivalent on May 18, 2010. 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.