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
73–96 of 1367
Cleared Mar 26, 1997
WIDEX SENSO DIGITAL (CIC)
K970904
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 14d
Cleared Mar 12, 1997
WIDEX MODEL SENSO DIGITAL (C9)
K965254
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 72d
Cleared Mar 11, 1997
ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCI
K970430
Midwest City Hearing Aid Center
Ear, Nose, Throat · 35d
Cleared Feb 26, 1997
AHS OMEGA SP
K970057
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 50d
Cleared Feb 11, 1997
SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF
K964657
Micro-Ear Technology, Inc.
Ear, Nose, Throat · 83d
Cleared Feb 04, 1997
PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS
K964245
Starkey Laboratories, Inc.
Ear, Nose, Throat · 103d
Cleared Feb 04, 1997
MIRACLE - EAR (ITE/ITC/CIC)
K964419
Miracle-Ear, Inc.
Ear, Nose, Throat · 126d
Cleared Jan 27, 1997
DAHLBERG (A-554)
K965049
Miracle-Ear, Inc.
Ear, Nose, Throat · 40d
Cleared Jan 27, 1997
AUDIOTONE (A554H)
K965057
Miracle-Ear, Inc.
Ear, Nose, Throat · 40d
Cleared Jan 27, 1997
AUDIOTONE (A-552)
K965063
Miracle-Ear, Inc.
Ear, Nose, Throat · 40d
Cleared Jan 24, 1997
COMFORTAID HEARING AID
K964680
Ethical Hearing Instruments
Ear, Nose, Throat · 63d
Cleared Jan 24, 1997
M11 SERIES: M11, M11M
K965088
Philips Hearing Instruments Co.
Ear, Nose, Throat · 36d
Cleared Jan 24, 1997
SENSO DIGITAL (C18)
K965218
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 25d
Cleared Jan 21, 1997
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II
K964639
Telex Communications, Inc.
Ear, Nose, Throat · 63d
Cleared Jan 17, 1997
AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR
K964816
Audina Hearing Instrument
Ear, Nose, Throat · 49d
Cleared Dec 26, 1996
MIRACLE-EAR OR AUDIOTONE
K964669
Miracle-Ear, Inc.
Ear, Nose, Throat · 35d
Cleared Dec 23, 1996
DAHLBERG K-AMP BTE
K964794
Miracle-Ear, Inc.
Ear, Nose, Throat · 24d
Cleared Dec 12, 1996
DIGIFOCUS ITE
K964683
Oticon, Inc.
Ear, Nose, Throat · 20d
Cleared Dec 06, 1996
AHS OMEGA CONCEPT
K963877
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 71d
Cleared Dec 06, 1996
AHS OMEGA HF
K963878
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 71d
Cleared Dec 06, 1996
ARTICULAR HEARING AIDS
K964603
Decibel Instruments, Inc.
Ear, Nose, Throat · 18d
Cleared Dec 05, 1996
IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT
K963958
Beltone Electronics Corp.
Ear, Nose, Throat · 64d
Cleared Dec 04, 1996
PHONAK MICROLINK, PERSONAL FM RECEIVER
K964035
Phonak, Inc.
Ear, Nose, Throat · 57d
Cleared Nov 27, 1996
PRIMOFOCUS COMPACT
K963788
Oticon Corp.
Ear, Nose, Throat · 68d