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
745–768 of 1367
Cleared Mar 25, 1985
EARETTE HEARING AID OTICON MODEL E32S
K850762
Oticon Corp.
Ear, Nose, Throat · 28d
Cleared Mar 25, 1985
EARETTE HEARING AID OTICON E32U
K850763
Oticon Corp.
Ear, Nose, Throat · 28d
Cleared Jan 23, 1985
HEARING AID, UNITRON UE12-PPL
K843246
Unitron Industries, Inc.
Ear, Nose, Throat · 156d
Cleared Jan 10, 1985
HEARING AID, UNITRON UE12-PP
K843245
Unitron Industries, Inc.
Ear, Nose, Throat · 143d
Cleared Jan 07, 1985
MODEL 363C HEARING AID
K844648
Telex Communications, Inc.
Ear, Nose, Throat · 39d
Cleared Dec 13, 1984
ULTRA & ULTRA MINATURE
K843789
Qualitone
Ear, Nose, Throat · 77d
Cleared Dec 03, 1984
HEARING AIDS 372 & 372 AI
K843068
Telex Communications, Inc.
Ear, Nose, Throat · 119d
Cleared Dec 03, 1984
RIONET HEARING AID HB-34AS
K844059
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 46d
Cleared Nov 16, 1984
PERSONAL AMPLIFIER SILENCER
K843980
Electone, Inc.
Ear, Nose, Throat · 36d
Cleared Nov 09, 1984
BEHIND-THE-EAR 123 VTH
K843791
Danavox, Inc.
Ear, Nose, Throat · 43d
Cleared Nov 09, 1984
RIONET HEARING AID HB-73
K844000
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 28d
Cleared Sep 05, 1984
TCA HEARING AID
K843067
Telex Communications, Inc.
Ear, Nose, Throat · 30d
Cleared Aug 24, 1984
RIONET HEARING AID HB-35
K842875
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 32d
Cleared Aug 23, 1984
EARETTE HEARING AID OTICON E31V
K842073
Oticon Corp.
Ear, Nose, Throat · 92d
Cleared Aug 23, 1984
EARETTE HEARING AID OTICON E30V
K842074
Oticon Corp.
Ear, Nose, Throat · 92d
Cleared Aug 14, 1984
RIONET HEARING AID HI-03
K841935
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 95d
Cleared Aug 02, 1984
CONFERETTE C2
K840893
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 157d
Cleared Jun 27, 1984
OTICON E28A
K841436
Oticon Corp.
Ear, Nose, Throat · 82d
Cleared Jun 22, 1984
IN-THE-EAR HEARING AID MODEL
K833486
Danavox, Inc.
Ear, Nose, Throat · 259d
Cleared Apr 17, 1984
MCA IN THE EAR CUSTOM HEARING AID
K840298
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 84d
Cleared Apr 03, 1984
CANAL AID
K840165
Qualitone
Ear, Nose, Throat · 78d
Cleared Mar 30, 1984
CANAL HEARING AID
K833773
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 155d
Cleared Mar 30, 1984
SERIES MR IN-THE-EAR CUSTOM HEARING AID
K840825
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 35d
Cleared Mar 30, 1984
HEARING AID UNITRON UE8
K840842
Unitron Industries, Inc.
Ear, Nose, Throat · 35d