510(k) K123962

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

K123962 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 April 8, 2013. 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.