DeviceClearance

Product code LXB— Ear, Nose, Throat

OTOMAG BONE CONDUCTION HEARING SYSTEM

Classification name
Hearing Aid, Bone Conduction
Device class
Class 2
Regulation
21 CFR 874.3302
Advisory panel
Ear, Nose, Throat
Total cleared
53
First cleared
Most recent

Market context for product code LXB

FDA has cleared 53 devices under product code LXB between 1986 and 2026, filed by 21 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code LXB

Adverse events under product code LXB

product code LXB
Injury
2,334
Total
2,334

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code LXB

Data sourced from openFDA. This site is unofficial and independent of the FDA.