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
169–192 of 1367
Cleared Jan 17, 1996
REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE INSTRUMENTS
K954922
Rexton, Inc.
Ear, Nose, Throat · 83d
Cleared Dec 22, 1995
MIRACLE EAR AND AUDIOTONE
K954941
Miracle-Ear, Inc.
Ear, Nose, Throat · 53d
Cleared Dec 22, 1995
RESOUND PERSONAL HEARING SYSTEM BTP W/DAI
K955574
Resound Corp.
Ear, Nose, Throat · 15d
Cleared Dec 19, 1995
CYBER III OPTION UM, UC312, UC10, UCIC
K955359
Qualitone
Ear, Nose, Throat · 27d
Cleared Dec 08, 1995
TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION
K954579
Telex Communications, Inc.
Ear, Nose, Throat · 67d
Cleared Dec 06, 1995
BELTONE ULTIMA 80 OTOSONIC POWER PAS
K954936
Beltone Electronics Corp.
Ear, Nose, Throat · 40d
Cleared Oct 18, 1995
WIDEX SENSO DIGITAL (PX)
K954526
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 19d
Cleared Oct 07, 1995
UNITRON MODEL IKON AOHPD
K953727
Unitron Industries, Inc.
Ear, Nose, Throat · 58d
Cleared Oct 07, 1995
UNITRON MODEL SOUND F/XD
K953932
Unitron Industries, Inc.
Ear, Nose, Throat · 61d
Cleared Oct 07, 1995
UNITRON MODEL SOUND F/X II
K954516
Unitron Industries, Inc.
Ear, Nose, Throat · 9d
Cleared Oct 07, 1995
MIRACLE - EAR MODEL PBP
K954528
Miracle-Ear, Inc.
Ear, Nose, Throat · 8d
Cleared Oct 06, 1995
UNITRON MODEL SOUND F/X
K954430
Unitron Industries, Inc.
Ear, Nose, Throat · 14d
Cleared Sep 28, 1995
MAICO PRODIGY CIC SERIES
K954054
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 30d
Cleared Sep 28, 1995
3M MODEL 8295
K954067
3M Company
Ear, Nose, Throat · 29d
Cleared Sep 18, 1995
REXTON MINI-PRIMO PLUS, PP142, D.C .H.I. FAMILY
K953770
Rexton, Inc.
Ear, Nose, Throat · 35d
Cleared Sep 18, 1995
PHONAK 9900 CIC
K953921
Phonak, Inc.
Ear, Nose, Throat · 28d
Cleared Sep 18, 1995
K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT
K954038
Argosy Electronics
Ear, Nose, Throat · 21d
Cleared Aug 28, 1995
UNITRON MODEL IKON AOHPL
K953646
Unitron Industries, Inc.
Ear, Nose, Throat · 24d
Cleared Aug 23, 1995
PHONAK PICONET 232X-AZ HEARING INSTRUMENT
K945439
Phonak, Inc.
Ear, Nose, Throat · 299d
Cleared Aug 23, 1995
3M MODEL 8200P MULTIPRO BTE
K953543
3M Company
Ear, Nose, Throat · 26d
Cleared Aug 22, 1995
Z20
K953047
Electone, Inc.
Ear, Nose, Throat · 53d
Cleared Aug 22, 1995
Z33
K953050
Electone, Inc.
Ear, Nose, Throat · 53d
Cleared Aug 15, 1995
Z22
K953048
Electone, Inc.
Ear, Nose, Throat · 46d
Cleared Aug 15, 1995
Z24
K953049
Electone, Inc.
Ear, Nose, Throat · 46d