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
97–120 of 1367
Cleared Nov 27, 1996
AHS OMEGA K-AMP
K963875
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 62d
Cleared Nov 27, 1996
STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS
K964214
Starkey Laboratories, Inc.
Ear, Nose, Throat · 36d
Cleared Nov 27, 1996
STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS
K964244
Starkey Laboratories, Inc.
Ear, Nose, Throat · 34d
Cleared Nov 27, 1996
PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC
K964451
Rexton, Inc.
Ear, Nose, Throat · 21d
Cleared Nov 27, 1996
UNITRON MODEL SOUND F/XP +4
K964502
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 27, 1996
UNITRON MODEL SOUND F/X +4
K964503
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 27, 1996
UNITRON MODEL ICON AOHPL +4
K964504
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 27, 1996
UNITRON MODEL ICON AOHP +4 (ICON AOHP +4)
K964508
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 27, 1996
UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4)
K964510
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 27, 1996
UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4)
K964511
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 27, 1996
DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT
K964530
Miracle-Ear, Inc.
Ear, Nose, Throat · 15d
Cleared Nov 27, 1996
RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION
K964557
Resound Corp.
Ear, Nose, Throat · 14d
Cleared Nov 26, 1996
MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR)
K963745
Hearing Innovations, Inc.
Ear, Nose, Throat · 70d
Cleared Nov 26, 1996
AHS OMEGA DEQ
K963873
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 61d
Cleared Nov 26, 1996
AHS OMEGA AGC
K963874
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 61d
Cleared Nov 26, 1996
AHS OMEGA PP
K963876
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 61d
Cleared Nov 26, 1996
AHS DELTA 22
K963879
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 61d
Cleared Nov 26, 1996
AHS DELTA 22 T
K963881
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 61d
Cleared Nov 26, 1996
AUDIO 'D' SOUND SELECTOR POWER (SSP)
K964180
Hearing Solutions, Inc.
Ear, Nose, Throat · 39d
Cleared Nov 08, 1996
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION
K963915
Telex Communications, Inc.
Ear, Nose, Throat · 39d
Cleared Nov 04, 1996
RESOUND CC4 PERSONAL HEARING SYSTEM
K964115
Resound Corp.
Ear, Nose, Throat · 20d
Cleared Oct 28, 1996
OVATION AGC-2
K963818
Orsonique, Inc.
Ear, Nose, Throat · 35d
Cleared Oct 28, 1996
OVATION ASP
K963819
Orsonique, Inc.
Ear, Nose, Throat · 35d
Cleared Oct 28, 1996
OVATION LINEAR
K963820
Orsonique, Inc.
Ear, Nose, Throat · 35d