MAH · Class II · 21 CFR 874.3302

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

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

12
Total
12
Cleared
128d
Avg days
1999
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Consistent review times: 141d avg (recent)

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

12 devices
1–12 of 12
Cleared Aug 26, 2026
Ponto 5 Mini
K261142
Oticon Medical AB
Ear, Nose, Throat · 141d
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 Jan 22, 2016
Ponto Bone Anchored Hearing System
K152820
Oticon Medical AB
Ear, Nose, Throat · 116d
Cleared Nov 23, 2015
Ponto bone anchored hearing system
K152067
Oticon Medical AB
Ear, Nose, Throat · 122d
Cleared Jul 15, 2015
BA400 14mm Abutment
K150555
Cochlear Americas
Ear, Nose, Throat · 133d
Cleared Jan 21, 2015
Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm
K142678
Oticon Medical AB
Ear, Nose, Throat · 124d
Cleared Oct 12, 2012
COCHLEAR BAHA IMPLANT SYSTEM
K121317
Cochlear Americas
Ear, Nose, Throat · 163d
Cleared Sep 07, 2012
PONTO BONE ANCHORED HEARING SYSTEM
K121228
Oticon Medical AB
Ear, Nose, Throat · 137d
Cleared Nov 18, 2011
OBC BONE ANCHORED HEARING SYSTEM
K112053
Oticon Medical AB
Ear, Nose, Throat · 122d
Cleared Apr 10, 2008
BAHA CORDELLE II
K080363
Cochlear Bone Anchored Systems AB
Ear, Nose, Throat · 59d
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

510(k) Submission Activity

12 total 510(k) submissions under product code MAH since 1999, with 12 receiving FDA clearance (average review time: 128 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MAH Product Code

FDA review times for MAH submissions have been consistent, averaging 141 days recently vs 127 days historically.

MAH devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →