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
433–456 of 1367
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
Cleared Feb 18, 1992
PREMIER K-AMP
K914799
Electone, Inc.
Ear, Nose, Throat · 118d
Cleared Feb 18, 1992
AM 300 XP
K914947
Electone, Inc.
Ear, Nose, Throat · 106d
Cleared Feb 14, 1992
RIONET HEARING AID HB-53P
K920486
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 15d
Cleared Jan 30, 1992
AUDIOTONE MODEL A-96
K920093
Miracle-Ear, Inc.
Ear, Nose, Throat · 22d
Cleared Jan 13, 1992
RIONET HEARING AID HB-71K (K-AMP)
K915875
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 25d
Cleared Jan 09, 1992
REXTON RX12 WITH HORIZON PROGRAMMABLE OPTION
K915683
Rexton, Inc.
Ear, Nose, Throat · 21d
Cleared Jan 09, 1992
REXTON RX34 WITH HORIZON PROGRAMMABLE OPTION
K915684
Rexton, Inc.
Ear, Nose, Throat · 21d
Cleared Dec 30, 1991
PHONAK 9000-AF ITE HEARING INSTRUMENT SERIES
K915461
Phonak, Inc.
Ear, Nose, Throat · 26d
Cleared Dec 05, 1991
PHILIPS P74P BEHIND-THE-EAR HEARING AID
K915252
Philips Hearing Instruments Co.
Ear, Nose, Throat · 17d
Cleared Nov 27, 1991
OTOSONIC (OSI) LPS IN-THE-EAR HEARING AID
K914981
Beltone Electronics Corp.
Ear, Nose, Throat · 21d
Cleared Nov 27, 1991
BELTONE PROFILE IN-THE-EAR HEARING AID
K914982
Beltone Electronics Corp.
Ear, Nose, Throat · 21d
Cleared Nov 22, 1991
OTOSONIC ACS-ASP
K914939
Beltone Electronics Corp.
Ear, Nose, Throat · 18d
Cleared Nov 22, 1991
BELTONE CLEARVOICE
K914940
Beltone Electronics Corp.
Ear, Nose, Throat · 18d
Cleared Nov 05, 1991
HEARING AID, UNITRON MODEL VISTA 3000
K914688
Unitron Industries, Inc.
Ear, Nose, Throat · 18d
Cleared Nov 05, 1991
HEARING AID, UNITRON MODEL VISTA 4000
K914689
Unitron Industries, Inc.
Ear, Nose, Throat · 18d
Cleared Nov 05, 1991
P54 BTE HEARING AID
K914800
Philips Hearing Instruments Co.
Ear, Nose, Throat · 13d
Cleared Oct 21, 1991
ACT-II BEHIND THE EAR HEARING AID
K914418
Telex Communications, Inc.
Ear, Nose, Throat · 18d