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
121–144 of 1367
Cleared Oct 28, 1996
OVATION AGC-1
K963821
Orsonique, Inc.
Ear, Nose, Throat · 35d
Cleared Oct 28, 1996
OVATION AGC-3
K963822
Orsonique, Inc.
Ear, Nose, Throat · 35d
Cleared Sep 27, 1996
EUROLINE A-675 SERIS
K963519
Starkey Laboratories, Inc.
Ear, Nose, Throat · 24d
Cleared Sep 27, 1996
DYNAMIC EQ II - 2 CHANNEL WIDE DYNAMIC RANGE COMPRESSION
K963604
Midwest City Hearing Aid Center
Ear, Nose, Throat · 18d
Cleared Sep 20, 1996
HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL
K963607
Midwest City Hearing Aid Center
Ear, Nose, Throat · 11d
Cleared Sep 16, 1996
IN THE EAR HEARING AID
K962388
Unique Hearing Technology, Inc.
Ear, Nose, Throat · 88d
Cleared Sep 10, 1996
AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY)
K963047
Fenwick Hearing Instruments
Ear, Nose, Throat · 43d
Cleared Sep 09, 1996
AUDIO 'D' K-AMP HR FULL SHELL AND CANAL HEARING AIDS
K962798
Hearing Solutions, Inc.
Ear, Nose, Throat · 53d
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 Aug 28, 1996
MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT
K962228
Ototech Intl., Inc.
Ear, Nose, Throat · 79d
Cleared Aug 09, 1996
MT10P, MT60-PP, MT60-AGC0, AND MT60
K962847
Micro-Tech Hearing Instruments
Ear, Nose, Throat · 18d
Cleared Aug 02, 1996
PHILIPS 71 SERIES
K961770
Philips Hearing Instruments Co.
Ear, Nose, Throat · 86d
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 29, 1996
ARGOSY PROGRAMMABLE
K961729
Argosy Electronics
Ear, Nose, Throat · 26d
Cleared May 17, 1996
PHONAK PICONET2 P2 AZ
K961622
Phonak, Inc.
Ear, Nose, Throat · 21d
Cleared May 14, 1996
CLARITY
K961670
Seig Technologies, Inc.
Ear, Nose, Throat · 14d
Cleared May 07, 1996
COMFORTONE PHS
K960741
Comfortone America'S Value Hearing Aid Line
Ear, Nose, Throat · 74d
Cleared May 07, 1996
DIGIFOCUS COMPACT
K961059
Oticon, Inc.
Ear, Nose, Throat · 50d