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
889–912 of 1367
Cleared Nov 05, 1979
RIONET HEARING AID HB-65T
K791881
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 66d
Cleared Oct 30, 1979
RIONET HEARING AID HB-32
K791876
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 60d
Cleared Oct 30, 1979
RIONET HEARING AID HB-32H
K791877
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 60d
Cleared Oct 30, 1979
RIONET HEARING AID HB-67T
K791882
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 60d
Cleared Oct 30, 1979
RIONET HEARING AID HI-60
K791884
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 60d
Cleared Oct 26, 1979
RIONET HEARING AID HB-64S
K791879
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 56d
Cleared Sep 28, 1979
DAHLBERG HEARING AID MODEL GC
K791310
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 74d
Cleared Sep 28, 1979
MODEL 33DA HEARING AIDS
K791599
Telex Communications, Inc.
Ear, Nose, Throat · 45d
Cleared Sep 28, 1979
MODEL 33A HEARING AIDS
K791600
Telex Communications, Inc.
Ear, Nose, Throat · 45d
Cleared Sep 28, 1979
MODEL 336A HEARING AIDS
K791601
Telex Communications, Inc.
Ear, Nose, Throat · 45d
Cleared Sep 19, 1979
DAHLBERG HEARING AID MODEL UN
K791311
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 65d
Cleared Sep 19, 1979
MODEL 344
K791506
Telex Communications, Inc.
Ear, Nose, Throat · 47d
Cleared Sep 17, 1979
EARETTE HEARING AID
K791356
Oticon Corp.
Ear, Nose, Throat · 59d
Cleared Aug 10, 1979
MODEL SE-1 EYEGLASS HEARING AID
K791203
Starkey Laboratories, Inc.
Ear, Nose, Throat · 43d
Cleared May 01, 1979
_MODEL WC-1 BEHIND-THE-EAR HEARING AID
K790745
Starkey Laboratories, Inc.
Ear, Nose, Throat · 15d
Cleared Apr 10, 1979
HEARING AID DANAVOX 775V
K790539
Danavox, Inc.
Ear, Nose, Throat · 21d
Cleared Apr 10, 1979
MODEL WC-3 HEARING AID
K790651
Starkey Laboratories, Inc.
Ear, Nose, Throat · 7d
Cleared Apr 03, 1979
MODEL 4107-2S, HEARING AID
K790482
Starkey Laboratories, Inc.
Ear, Nose, Throat · 26d
Cleared Apr 03, 1979
BEHIND-THE-EAR HEARING AID
K790515
Danavox, Inc.
Ear, Nose, Throat · 19d
Cleared Mar 19, 1979
MODEL 337E HEARING AID
K790412
Telex Communications, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 06, 1979
MODEL 342 HEARING AIDS
K790354
Telex Communications, Inc.
Ear, Nose, Throat · 12d
Cleared Mar 06, 1979
MODEL 342D HEARING AIDS
K790355
Telex Communications, Inc.
Ear, Nose, Throat · 12d
Cleared Feb 27, 1979
HEARING AID MODEL 8143
K790270
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 28d
Cleared Feb 26, 1979
HEARING AID, OTICON I II H
K790301
Oticon Corp.
Ear, Nose, Throat · 14d