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
241–264 of 1367
Cleared Jan 30, 1995
UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID
K946323
Unitron Industries, Inc.
Ear, Nose, Throat · 32d
Cleared Jan 26, 1995
UNITRON MODEL SOUNG F/S
K946264
Unitron Industries, Inc.
Ear, Nose, Throat · 34d
Cleared Jan 26, 1995
PHONAK SONO-FORTE 332X-AZ
K946294
Phonak, Inc.
Ear, Nose, Throat · 30d
Cleared Jan 24, 1995
3M MODEL 8233 HEARING INSTRUMENT
K943854
3M Company
Ear, Nose, Throat · 169d
Cleared Jan 19, 1995
RESOUND PERSONAL HEARING SYSTEMS MODIFICATION
K934917
Resound Corp.
Ear, Nose, Throat · 463d
Cleared Jan 05, 1995
SIEMENS 10A FACEPLATE WITH CIC INSTRUMENTS
K943380
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 176d
Cleared Dec 30, 1994
ORION PPM, PP, PP-D
K944777
Rexton, Inc.
Ear, Nose, Throat · 94d
Cleared Dec 29, 1994
EXPRESSION RX-12, ENHANCEMENT RX-34, ELITE RX-12
K944359
Rexton, Inc.
Ear, Nose, Throat · 113d
Cleared Dec 27, 1994
LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS
K944174
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 123d
Cleared Dec 27, 1994
MO4 SERIES
K944404
Philips Hearing Instruments Co.
Ear, Nose, Throat · 110d
Cleared Dec 27, 1994
WIDEX MODEL LOGO 8S
K944518
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 102d
Cleared Dec 27, 1994
AIR CONDUCTION HEARING AID
K944520
Unitron Industries, Inc.
Ear, Nose, Throat · 102d
Cleared Dec 27, 1994
SIEMENS FRONTIER SERICE, MODELS S-1,S-2 AND S-3 MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS
K944645
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 97d
Cleared Dec 23, 1994
BTP-A HEARING SYSTEM
K944043
Resound Corp.
Ear, Nose, Throat · 127d
Cleared Dec 23, 1994
WIDEX MODEL LOGO - L9
K945703
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 51d
Cleared Dec 21, 1994
DEEP CANAL HEARING INSTRUMENT
K942702
Rexton, Inc.
Ear, Nose, Throat · 196d
Cleared Dec 21, 1994
IMAGE
K944161
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 117d
Cleared Dec 14, 1994
ADOBE C.I.C
K943016
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 173d
Cleared Nov 15, 1994
COMPASS SOFTWARE MODULE
K944097
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 85d
Cleared Nov 14, 1994
REXPLUS PP3
K944548
Rexton, Inc.
Ear, Nose, Throat · 59d
Cleared Oct 21, 1994
PROGRAM 3-CH SER HEAR AIDS W/PROGRAM FIT SYST/PRO FIT
K944078
Argosy Electronics
Ear, Nose, Throat · 60d
Cleared Oct 20, 1994
FEDELITY F495, VIENNATONE ALPP II
K943687
Starkey Laboratories, Inc.
Ear, Nose, Throat · 83d
Cleared Oct 20, 1994
UV CURED METHYL METHACRYLATE HEARING AID SHELL MATERIALS
K943960
Miracle-Ear, Inc.
Ear, Nose, Throat · 66d
Cleared Oct 20, 1994
BELTONE CONCERTO S
K944502
Beltone Electronics Corp.
Ear, Nose, Throat · 36d