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
769–792 of 1367
Cleared Mar 30, 1984
BEHIND-THE-EAR HEARING AID 2000
K840871
Telex Communications, Inc.
Ear, Nose, Throat · 32d
Cleared Mar 30, 1984
RIONET HEARING AID HB-71M
K841012
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Feb 21, 1984
POST-AURICULAR HEARING AID
K840359
Phonic Ear, Inc.
Ear, Nose, Throat · 26d
Cleared Dec 19, 1983
HEARING AID
K833926
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 35d
Cleared Dec 08, 1983
OTICON, E26P
K833803
Oticon Corp.
Ear, Nose, Throat · 37d
Cleared Nov 21, 1983
PERSONAL AMPLIFIER
K832168
Electone, Inc.
Ear, Nose, Throat · 138d
Cleared Nov 21, 1983
HEARING AID, UNITRON UT1
K833614
Unitron Industries, Inc.
Ear, Nose, Throat · 39d
Cleared Nov 21, 1983
HEARING AID UNITRON UI3
K833615
Unitron Industries, Inc.
Ear, Nose, Throat · 39d
Cleared Nov 14, 1983
RIONET HEARING AID HB-345
K833134
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 62d
Cleared Oct 28, 1983
DAHLBERG #USS IN THE EAR HEARING AID
K833073
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 49d
Cleared Sep 29, 1983
REXTON RX10, RX20-30 & 40
K832180
Rexton, Inc.
Ear, Nose, Throat · 85d
Cleared Sep 29, 1983
BEHIND-THE-EAR #123 AGCI
K832326
Danavox, Inc.
Ear, Nose, Throat · 76d
Cleared Sep 29, 1983
WIDEX HEARING AID MODEL L1
K832376
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 73d
Cleared Sep 29, 1983
BEHIND-THE-EAR SERIES 125
K832751
Danavox, Inc.
Ear, Nose, Throat · 45d
Cleared Aug 12, 1983
HEARING AID UNITRON #UE8-D
K831883
Unitron Industries, Inc.
Ear, Nose, Throat · 60d
Cleared Aug 01, 1983
PHONIC EAR PE 845PPC-D
K832081
Phonic Ear, Inc.
Ear, Nose, Throat · 34d
Cleared Jul 26, 1983
HEARING AID G3H & G3T
K832129
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 25d
Cleared Jul 12, 1983
PERSONAL AMPLIFIER MODULE
K830790
Electone, Inc.
Ear, Nose, Throat · 120d
Cleared Jul 07, 1983
RIONET HEARING AID -AND/OR RION
K831721
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 37d
Cleared May 09, 1983
WIDEX HEARING AID #G2H & G2T
K830465
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 83d
Cleared May 09, 1983
MODEL 343D HEARING AID
K831197
Telex Communications, Inc.
Ear, Nose, Throat · 27d
Cleared Mar 24, 1983
RIONET HEARING AID
K830236
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 58d
Cleared Mar 07, 1983
800 BLUE
K830303
Electone, Inc.
Ear, Nose, Throat · 38d
Cleared Mar 07, 1983
HEARING AID, #UE7-D
K830402
Unitron Industries, Inc.
Ear, Nose, Throat · 28d