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 Mar 18, 1993
CE-9 IN-THE-EAR HEARING AID
K930805
Starkey Laboratories, Inc.
Ear, Nose, Throat · 30d
Cleared Mar 18, 1993
INTRA V AND SECRET EAR III
K930853
Starkey Laboratories, Inc.
Ear, Nose, Throat · 28d
Cleared Mar 01, 1993
BELTONE OPTIMA 2000 CLEARVOICE SERIES, IN-THE-EAR
K930310
Beltone Electronics Corp.
Ear, Nose, Throat · 38d
Cleared Mar 01, 1993
BELTONE OPERA LOR, ITC
K930318
Beltone Electronics Corp.
Ear, Nose, Throat · 38d
Cleared Feb 12, 1993
AUDIOTONE MODEL A-98
K926091
Miracle-Ear, Inc.
Ear, Nose, Throat · 72d
Cleared Feb 12, 1993
MIRACLE-EAR MODEL HL
K926092
Miracle-Ear, Inc.
Ear, Nose, Throat · 72d
Cleared Feb 08, 1993
VISTA 4000 SIGMA
K925600
Unitron Industries, Inc.
Ear, Nose, Throat · 95d
Cleared Feb 02, 1993
WIDEX MODEL D16
K926085
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 62d
Cleared Feb 02, 1993
SOUNDCHOICE WITH VARIABLE SLOPE
K926476
Bausch & Lomb, Inc.
Ear, Nose, Throat · 35d
Cleared Feb 01, 1993
PHONAK PICONET 231-X
K930145
Phonak, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 27, 1993
WIDEX MODEL D8 (HEARING AID)
K926244
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 47d
Cleared Nov 24, 1992
P54-0 BEHIND THE EAR HEARING AID
K924887
Electone, Inc.
Ear, Nose, Throat · 57d
Cleared Nov 24, 1992
P54 HEARING AID
K924888
Electone, Inc.
Ear, Nose, Throat · 57d
Cleared Nov 04, 1992
PHONAK PICO-FORTE PP-SC-2 BTE HEARING INSTRUMENT
K924911
Phonak, Inc.
Ear, Nose, Throat · 36d
Cleared Nov 04, 1992
PHONAK PICO-FORTE PPC-L-P-2 BTE HEARING INSTR
K924913
Phonak, Inc.
Ear, Nose, Throat · 36d
Cleared Nov 04, 1992
PHONAK PICO-FORTE PPC-P-2 BTE HEARING INSTRUMENT
K924914
Phonak, Inc.
Ear, Nose, Throat · 36d
Cleared Nov 03, 1992
PHONAK PICO-FORTE C-2 BTE HEARING INSTRUMENT
K924912
Phonak, Inc.
Ear, Nose, Throat · 35d
Cleared Sep 28, 1992
DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT
K923071
Life-Tech Intl., Inc.
Ear, Nose, Throat · 95d
Cleared Sep 28, 1992
SOUNDCHOICE K-AMP
K923735
Bausch & Lomb, Inc.
Ear, Nose, Throat · 63d
Cleared Sep 28, 1992
BTE WITH ACCESSORY ATTACHED
K923743
Phonak, Inc.
Ear, Nose, Throat · 63d
Cleared Sep 28, 1992
RIONET HB75-AL BTE AID
K923801
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 61d
Cleared Sep 10, 1992
CYBERNETIC OPTION (CYBER I)
K923986
Qualitone
Ear, Nose, Throat · 34d
Cleared Aug 26, 1992
STARKEY SM SERIES BTE HEARING AIDS
K923784
Starkey Laboratories, Inc.
Ear, Nose, Throat · 29d
Cleared Aug 18, 1992
SIEMENS MODEL INFINITI 1001 B
K923379
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 40d