MAH · Class II · 21 CFR 874.3302

FDA Product Code MAH: Hearing Aid, Bone Conduction, Implanted

Leading manufacturers include Cochlear Americas, Oticon Medical AB and Nobelpharma USA, Inc..

11
Total
11
Cleared
127d
Avg days
1999
Since

FDA 510(k) Cleared Hearing Aid, Bone Conduction, Implanted Devices (Product Code MAH)

11 devices
1–11 of 11
Cleared Mar 03, 2021
Ponto Bone Anchored Hearing System, MONO Surgery Kit
K203807
Oticon Medical AB
Ear, Nose, Throat · 65d
Cleared Dec 19, 2018
BA310 Abutment, BIA310 Implant/Abutment
K182116
Cochlear Americas
Ear, Nose, Throat · 135d
Cleared Jun 28, 1999
BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE
K984162
Nobelpharma USA, Inc.
Ear, Nose, Throat · 221d

About Product Code MAH - Regulatory Context