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
265–288 of 1367
Cleared Oct 20, 1994
WIDEX MODEL LX-ITE
K944838
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 20d
Cleared Oct 12, 1994
PROGRAM 3-CH SERIES HEAR AIDS W/DT-1 DESKTOP PROGRAM
K944077
Argosy Electronics
Ear, Nose, Throat · 51d
Cleared Sep 23, 1994
MIRACLE-EAR IMPRESSION MATERIAL KIT
K942523
Miracle-Ear, Inc.
Ear, Nose, Throat · 161d
Cleared Sep 23, 1994
MIRACLE-EAR MIRAGE
K943826
Miracle-Ear, Inc.
Ear, Nose, Throat · 49d
Cleared Sep 21, 1994
RESOUND PERSONAL HEARING SYSTEM
K943788
Resound Corp.
Ear, Nose, Throat · 49d
Cleared Sep 21, 1994
MIRACLE EAR CONFIDANTE
K943825
Miracle-Ear, Inc.
Ear, Nose, Throat · 47d
Cleared Sep 07, 1994
SIEMENS MODEL 584 P-2
K934752
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 338d
Cleared Sep 07, 1994
INFINITY 252
K935019
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 322d
Cleared Aug 22, 1994
SIEMENS BTE HEARING AIDS
K942857
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 67d
Cleared Aug 22, 1994
AUDILENS LLK
K943706
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 21d
Cleared Aug 18, 1994
MO6 SERIES
K943670
Philips Hearing Instruments Co.
Ear, Nose, Throat · 23d
Cleared Aug 17, 1994
MIRACLE-EAR MODEL PGF + REMOTE
K942893
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 58d
Cleared Aug 17, 1994
MIRACLE-EAR MODEL PGC
K942894
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 58d
Cleared Aug 17, 1994
MIRACLE EAR MODEL PGM
K942895
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 58d
Cleared Aug 17, 1994
SM-VEGA, SM-PC, SM-AGC, SM-AGC-H
K943682
Starkey Laboratories, Inc.
Ear, Nose, Throat · 22d
Cleared Aug 09, 1994
STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AID
K940667
Starkey Laboratories, Inc.
Ear, Nose, Throat · 174d
Cleared Aug 09, 1994
PHILIPS M38 SERIES
K943395
Philips Hearing Instruments Co.
Ear, Nose, Throat · 26d
Cleared Jul 25, 1994
MIRACLE-EAR EAR IMPRESSION MATERIAL
K941859
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 101d
Cleared Jul 18, 1994
HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT
K942749
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 38d
Cleared Jul 05, 1994
STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID
K942594
Starkey Laboratories, Inc.
Ear, Nose, Throat · 34d
Cleared Jun 24, 1994
EUROSTAR SUPER, EUROSTAR VFC
K942036
Starkey Laboratories, Inc.
Ear, Nose, Throat · 57d
Cleared Jun 17, 1994
SHARP II HELIX HEARING AID
K941295
Miracle-Ear, Inc.
Ear, Nose, Throat · 92d
Cleared Jun 17, 1994
PHILIPS 61 SERIES
K942164
Philips Hearing Instruments Co.
Ear, Nose, Throat · 44d
Cleared Jun 17, 1994
OPTIMA WITH DELTA AMP
K942213
Beltone Electronics Corp.
Ear, Nose, Throat · 42d