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
289–312 of 1367
Cleared Aug 18, 1992
SIEMENS MODEL TRITON 3004 B
K923380
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 40d
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 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
Cleared Feb 19, 1992
AM 300 AGC-O
K914948
Electone, Inc.
Ear, Nose, Throat · 107d
Cleared Feb 19, 1992
RIONET HEARING AID HB-23T
K920521
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 15d
Cleared Feb 19, 1992
RIONET HEARING AID HB-23M
K920522
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 15d
Cleared Feb 18, 1992
ELECTONE/PA RECHARGEABLE
K914795
Electone, Inc.
Ear, Nose, Throat · 118d
Cleared Feb 18, 1992
PREMIER ASP/CD RECHARGEABLE
K914796
Electone, Inc.
Ear, Nose, Throat · 118d
Cleared Feb 18, 1992
PREMIER CD RECHARGEABLE
K914797
Electone, Inc.
Ear, Nose, Throat · 118d
Cleared Feb 18, 1992
PREMIER CLASS D-ASP
K914798
Electone, Inc.
Ear, Nose, Throat · 118d