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
409–432 of 1367
Cleared Sep 28, 1992
BTE WITH ACCESSORY ATTACHED
K923743
Phonak, Inc.
Ear, Nose, Throat · 63d
Cleared Sep 28, 1992
RIONET HB75-AL BTE AID
K923801
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 61d
Cleared Sep 10, 1992
CYBERNETIC OPTION (CYBER I)
K923986
Qualitone
Ear, Nose, Throat · 34d
Cleared Aug 26, 1992
STARKEY SM SERIES BTE HEARING AIDS
K923784
Starkey Laboratories, Inc.
Ear, Nose, Throat · 29d
Cleared Aug 18, 1992
SIEMENS MODEL INFINITI 1001 B
K923379
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 40d
Cleared Aug 18, 1992
SIEMENS MODEL TRITON 3004 B
K923380
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 40d
Cleared Aug 11, 1992
PHILIP XP SERIES, IN-THE CANAL HEARING AID
K921725
Philips Hearing Instruments Co.
Ear, Nose, Throat · 124d
Cleared Aug 06, 1992
BTE HEARING AID OTICON MODEL: MULTIFOCUS POWER
K923388
Oticon Corp.
Ear, Nose, Throat · 30d
Cleared Aug 06, 1992
BTE HEARING AID PERSONIC 410
K923490
Oticon Corp.
Ear, Nose, Throat · 22d
Cleared Aug 06, 1992
BTE HEARING AID PERSONIC 425
K923491
Oticon Corp.
Ear, Nose, Throat · 23d
Cleared Jul 06, 1992
A-ZILICONE
K905555
Oticon Corp.
Ear, Nose, Throat · 573d
Cleared Jul 01, 1992
OTOSONIC ACS K
K922827
Beltone Electronics Corp.
Ear, Nose, Throat · 19d
Cleared Jun 30, 1992
WIDEX MODEL D32
K922708
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 25d
Cleared Jun 10, 1992
BELTONE OPERA CLEARVOICE IC, ITC (IN THE CANAL)
K922301
Beltone Electronics Corp.
Ear, Nose, Throat · 26d
Cleared May 27, 1992
OTOSONIC ACS-IC
K922224
Beltone Electronics Corp.
Ear, Nose, Throat · 15d
Cleared May 22, 1992
PHILIPS 31 SERIES IN THE EAR HEARING AID
K921463
Philips Hearing Instruments Co.
Ear, Nose, Throat · 56d
Cleared May 18, 1992
TELEX MODEL M29 ITE CUSTOM HEARING AID
K922065
Telex Communications, Inc.
Ear, Nose, Throat · 14d
Cleared May 18, 1992
TELEX MODEL 28A ITE CUSTOM HEARING AID
K922066
Telex Communications, Inc.
Ear, Nose, Throat · 14d
Cleared May 08, 1992
LIFESOUND ITE (LSI-I)W/ TRITON 3004I PROGRAMMABLE
K921656
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 31d
Cleared Apr 29, 1992
RIONET HEARING AID HB-52S
K921829
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 13d
Cleared Apr 28, 1992
RIONET HEARING AID HB-52T
K921830
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 12d
Cleared Mar 30, 1992
SOUNDCHOICE BTE
K921122
Bausch & Lomb, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 19, 1992
RIONET HEARING AID - HB 52DU
K920897
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 22d
Cleared Mar 19, 1992
BELTONE OPRA CLEAR VOICE-K HEARING AID
K921023
Beltone Electronics Corp.
Ear, Nose, Throat · 16d