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
865–888 of 1367
Cleared Mar 19, 1980
BEHIND EAR HEARING AID MODEL E24C1
K800244
Oticon Corp.
Ear, Nose, Throat · 43d
Cleared Mar 12, 1980
MODEL 795U BEHIND THE EAR HEARING AID
K800345
Danavox, Inc.
Ear, Nose, Throat · 22d
Cleared Feb 28, 1980
DAHLBERG # AF BEHING THE EAR HEARING/AID
K800181
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 30d
Cleared Feb 26, 1980
OTICON MODEL E17VF EARETTE HEARING AID
K800283
Oticon Corp.
Ear, Nose, Throat · 18d
Cleared Feb 26, 1980
OTICON MODEL E19VF EARETTE HEARING AID
K800316
Oticon Corp.
Ear, Nose, Throat · 14d
Cleared Feb 11, 1980
SEARS BEHIND-THE-EAR HEARING AID
K800113
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 26d
Cleared Jan 29, 1980
RIONET HEARING AID HE-71
K800011
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 25d
Cleared Jan 29, 1980
RIONET HEARING AID HA-61
K800012
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 25d
Cleared Jan 23, 1980
WIDEX HEARING AID MODEL S10
K792389
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 58d
Cleared Jan 23, 1980
WIDEX HEARING AID MODEL 820
K792567
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 58d
Cleared Jan 23, 1980
HEARING AID, MODELS DRI-35/DL1-35
K792643
Unitron Industries, Inc.
Ear, Nose, Throat · 28d
Cleared Jan 09, 1980
MODEL 339 TELECROS WIRELESS BICROS
K792462
Telex Communications, Inc.
Ear, Nose, Throat · 37d
Cleared Jan 09, 1980
MODEL 339 TELECROS WIRELESS CROS
K792463
Telex Communications, Inc.
Ear, Nose, Throat · 37d
Cleared Jan 09, 1980
MODEL 341H (HEARING AID)
K792464
Telex Communications, Inc.
Ear, Nose, Throat · 37d
Cleared Dec 27, 1979
RIONET HEARING AID HB-32T
K792505
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 23d
Cleared Dec 27, 1979
RIONET HEARING AID HB-68L
K792506
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 23d
Cleared Dec 18, 1979
HEARING AID, UNITRON MODEL 905H
K792236
Unitron Industries, Inc.
Ear, Nose, Throat · 42d
Cleared Dec 18, 1979
BEHINDTHEEAR HEAR. AID MOD. 793U,M,UH,MH
K792334
Danavox, Inc.
Ear, Nose, Throat · 29d
Cleared Dec 05, 1979
HEARING AID, UNITRON MODEL 905W
K792237
Unitron Industries, Inc.
Ear, Nose, Throat · 29d
Cleared Nov 30, 1979
DAHLBERG MODEL AE HIGH FREQUENCY / AID
K792278
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 17d
Cleared Nov 27, 1979
SERIES S (BEHIND-THE-EAR-HEARING AID)
K792198
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 26d
Cleared Nov 05, 1979
RIONET HEARING AID MODEL HA-55
K791739
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 66d
Cleared Nov 05, 1979
RIONET HEARING AID HB-64C
K791878
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 66d
Cleared Nov 05, 1979
RIONET HEARING AID HB-64T
K791880
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 66d