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
49–72 of 1367
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
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 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 Sep 27, 1996
EUROLINE A-675 SERIS
K963519
Starkey Laboratories, Inc.
Ear, Nose, Throat · 24d
Cleared Sep 06, 1996
UNITRON MODEL ICON KR
K963122
Unitron Industries, Inc.
Ear, Nose, Throat · 25d
Cleared Sep 05, 1996
RIONET HB-55AS
K963152
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 23d
Cleared Sep 05, 1996
RIONET HB-55S
K963153
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 23d
Cleared Sep 05, 1996
RIONET HB-54AS
K963154
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 22d
Cleared Jul 25, 1996
SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP
K962170
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 50d
Cleared Jul 03, 1996
IN-THE-EAR
K961827
Qualitone
Ear, Nose, Throat · 51d
Cleared Jul 03, 1996
RIONET HEARING AID HB53-K
K961907
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 48d
Cleared May 29, 1996
PHONAK SONA P2
K961653
Phonak, Inc.
Ear, Nose, Throat · 29d
Cleared May 17, 1996
PHONAK PICONET2 P2 AZ
K961622
Phonak, Inc.
Ear, Nose, Throat · 21d
Cleared May 07, 1996
TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40
K961143
Telex Communications, Inc.
Ear, Nose, Throat · 47d
Cleared Apr 18, 1996
AM 400
K961084
Electone, Inc.
Ear, Nose, Throat · 30d
Cleared Apr 10, 1996
RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES, EDR-EV, & EDR-P1
K960680
Resound Corp.
Ear, Nose, Throat · 50d