510(k) K102199

OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M) by Sophono, Inc. — Product Code LXB

K102199 is an FDA 510(k) premarket notification submitted by Sophono, Inc. for the device "OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)". The FDA issued a decision of Substantially Equivalent on May 23, 2011. 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.