ESD · Class I · 21 CFR 874.3300

FDA Product Code ESD: Hearing Aid, Air-conduction, Prescription

An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.

Leading manufacturers include Unitron Industries, Inc., Miracle-Ear, Inc. and Electone, Inc..

1367
Total
1367
Cleared
56d
Avg days
1976
Since
1367 devices
937–960 of 1367
Cleared Nov 21, 1977
HEARING AID-MODEL CE-2
K772100
Starkey Laboratories, Inc.
Ear, Nose, Throat · 14d
Cleared Nov 21, 1977
HEARING AID-MODEL PE-1
K772101
Starkey Laboratories, Inc.
Ear, Nose, Throat · 14d
Cleared Aug 25, 1977
HEARING AID MODEL 775
K771607
Danavox, Inc.
Ear, Nose, Throat · 3d
Cleared Jun 24, 1977
MULTISONIC (SUPER) CODE TSM
K771069
Qualitone
Ear, Nose, Throat · 11d
Cleared Jun 22, 1977
MULTISONIC (DELUXE) CODE TDM
K771029
Qualitone
Ear, Nose, Throat · 13d
Cleared Jun 14, 1977
HEARING AID, SERIES R
K770960
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 18d
Cleared May 25, 1977
HEARING AID, SERIES K-BEHIND-THE-EAR
K770885
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 9d
Cleared Apr 20, 1977
HEARING AID MODEL F8H ANL F8T
K770688
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 7d
Cleared Apr 20, 1977
HEARING AID MODEL A8H AND A8T
K770689
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 7d
Cleared Mar 02, 1977
HEARING AID, MAICO DB-POWER
K770373
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 5d
Cleared Feb 28, 1977
HEARING AID, DM IROS DIRECTIONAL
K770308
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 12d
Cleared Feb 28, 1977
HEARING AID, DM IROS
K770309
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 12d
Cleared Feb 28, 1977
PERCEPTOR
K770321
Danavox, Inc.
Ear, Nose, Throat · 11d
Cleared Feb 28, 1977
HEARING AID, MAICO DM MARK 180
K770360
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 6d
Cleared Dec 16, 1976
WIDEX HEARING AID MODEL F8
K761223
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 8d
Cleared Dec 02, 1976
WIDEX HEARING AID MODEL F7H & F7T
K761103
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 14d
Cleared Nov 16, 1976
HEARING AID (MODEL 695D, 905 & 960P)
K760996
Unitron Industries, Inc.
Ear, Nose, Throat · 8d
Cleared Nov 03, 1976
COMPRESSION ADJUSTRETTE
K760887
Qualitone
Ear, Nose, Throat · 12d