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
913–936 of 1367
Cleared Feb 12, 1979
EARETTE HEARING AID
K790228
Oticon Corp.
Ear, Nose, Throat · 10d
Cleared Jan 26, 1979
MODULE PERSONAL EAR (SUPER)
K790093
Qualitone
Ear, Nose, Throat · 10d
Cleared Jan 26, 1979
MODULE PERSONAL EAR (COMPRESSION)
K790094
Qualitone
Ear, Nose, Throat · 10d
Cleared Jan 26, 1979
MODULE PERSONAL EAR (DELUXE)
K790095
Qualitone
Ear, Nose, Throat · 10d
Cleared Jan 22, 1979
HEARING AID, MODEL GB
K782121
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 26d
Cleared Jan 22, 1979
HEARING AID, MODEL AA
K782122
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 26d
Cleared Nov 15, 1978
HEARING AID, MODEL 781
K781881
Danavox, Inc.
Ear, Nose, Throat · 9d
Cleared Oct 10, 1978
HEARING AID, ITE MODULAR MODEL I, II, V
K781663
Oticon Corp.
Ear, Nose, Throat · 12d
Cleared Sep 27, 1978
BODY-WORN HEARING AID, MODEL 787PP
K781595
Danavox, Inc.
Ear, Nose, Throat · 12d
Cleared Sep 27, 1978
HEARING AID, MODEL 775 PP/AGC
K781596
Danavox, Inc.
Ear, Nose, Throat · 12d
Cleared Sep 14, 1978
HEARING AID, UNITRON MODEL 960PL
K781513
Unitron Industries, Inc.
Ear, Nose, Throat · 13d
Cleared Sep 11, 1978
HEARING AID, UNITRON MODEL 761P
K781502
Unitron Industries, Inc.
Ear, Nose, Throat · 12d
Cleared Aug 31, 1978
HEARING AID, UNITRON MODEL 975
K781434
Unitron Industries, Inc.
Ear, Nose, Throat · 10d
Cleared Aug 31, 1978
HEARING AID, UNITRON MODEL 958
K781439
Unitron Industries, Inc.
Ear, Nose, Throat · 13d
Cleared Aug 14, 1978
HEARING AID, MODEL 783DU
K781212
Danavox, Inc.
Ear, Nose, Throat · 28d
Cleared May 31, 1978
HEARING AID MODEL 8148
K780820
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 12d
Cleared May 31, 1978
HEARING AID MODEL 8160H
K780821
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 12d
Cleared May 31, 1978
HEARING AID MODEL 8160U
K780822
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 12d
Cleared Apr 28, 1978
HEARING AID, EARETTE
K780654
Oticon Corp.
Ear, Nose, Throat · 9d
Cleared Feb 28, 1978
IN-THE-EAR HEARING AID, MODEL CE-3
K780309
Starkey Laboratories, Inc.
Ear, Nose, Throat · 5d
Cleared Feb 21, 1978
HEARING AID, BODY WORN
K780197
Oticon Corp.
Ear, Nose, Throat · 15d
Cleared Feb 17, 1978
COMPRESSION MULTISONIC
K780241
Qualitone
Ear, Nose, Throat · 4d
Cleared Jan 20, 1978
HEARING AID, BEHIND-THE-EAR
K780067
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 8d
Cleared Dec 20, 1977
HEARING AID, BODY TYPE, MODEL H
K772201
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 20d