510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MAHClass II

Hearing Aid, Bone Conduction, Implanted

21 CFR 874.3302 / Ear, Nose, Throat
FDA source (opens on fda.gov)

MAH is the FDA product code for Hearing Aid, Bone Conduction, Implanted, a class II device type, regulated under 21 CFR 874.3302. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MAH
Device name
Hearing Aid, Bone Conduction, Implanted
Regulation
21 CFR 874.3302
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
0

Clearances, product code MAH

By decision year
12 clearances under product code MAH with a decision year between 1999 and 2026, 2015 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code MAH by decision year
YearClearances
19991
20081
20111
20122
20153
20161
20181
20211
20261

Applicants with the most clearances

Product code MAH
Applicants holding the most 510(k) clearances under product code MAH
ApplicantClearances
Oticon Medical AB6
Cochlear Americas3
Cochlear Bone Anchored Systems AB1
Nobelpharma USA, Inc.1
Oticon Medical AB1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order