DeviceClearance

Product code MAH— Ear, Nose, Throat

BA310 Abutment, BIA310 Implant/Abutment

Classification name
Hearing Aid, Bone Conduction, Implanted
Device class
Class 2
Regulation
21 CFR 874.3302
Advisory panel
Ear, Nose, Throat
Total cleared
12
First cleared
Most recent

Market context for product code MAH

FDA has cleared 12 devices under product code MAH between 1999 and 2026, filed by 4 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

Top applicants under product code MAH

Adverse events under product code MAH

product code MAH
Injury
4,155
Total
4,155

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 MAH

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