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
505–528 of 1367
Cleared Feb 28, 1991
PHILIPS MODEL S46-O BTE HEARING AID
K910744
Philips Hearing Instruments Co.
Ear, Nose, Throat · 7d
Cleared Feb 28, 1991
3M MODEL 8241 ITE HEARING AID
K910759
3M Company
Ear, Nose, Throat · 9d
Cleared Feb 28, 1991
3M MODEL 8242 ITE HEARING AID
K910760
3M Company
Ear, Nose, Throat · 9d
Cleared Feb 28, 1991
3M MODEL 8243 ITE HEARING AID
K910761
3M Company
Ear, Nose, Throat · 9d
Cleared Feb 28, 1991
3M MODEL 8244 ITE HEARING AID
K910762
3M Company
Ear, Nose, Throat · 9d
Cleared Feb 28, 1991
3M MODEL 8245 ITE HEARING AID
K910763
3M Company
Ear, Nose, Throat · 9d
Cleared Feb 05, 1991
PHILIPS MODEL S47 BTE HEARING AID
K910206
Philips Hearing Instruments Co.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM900 PP
K910096
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM 240 HF
K910099
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM 130 D
K910100
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM 130 PP
K910101
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM 240 PPL
K910102
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM 130 HF
K910103
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
AM130 AGC-O (BEHIND THE EAR) HEARING AID
K910148
Electone, Inc.
Ear, Nose, Throat · 15d
Cleared Jan 28, 1991
ELECTONE BTE MODEL AM 240 PPI
K910098
Electone, Inc.
Ear, Nose, Throat · 19d
Cleared Dec 28, 1990
MEMORYMATE MODEL 8270 ITE HEARING AID
K905483
3M Company
Ear, Nose, Throat · 22d
Cleared Dec 21, 1990
HEARSET TELEPHONE HEARING SYSTEM
K903145
Starkey Laboratories, Inc.
Ear, Nose, Throat · 156d
Cleared Dec 17, 1990
MEMORYMATE HEARING AID WITH PMC PROGRAMMER
K904020
3M Company
Ear, Nose, Throat · 109d
Cleared Dec 17, 1990
QUALITONE ITE GENESIS
K904731
Qualitone
Ear, Nose, Throat · 61d
Cleared Dec 07, 1990
HEARING AID, UNITRON MODEL UM60-UH
K904576
Unitron Industries, Inc.
Ear, Nose, Throat · 59d
Cleared Dec 07, 1990
QUALITONE ULTRA CANAL GENESIS
K904730
Qualitone
Ear, Nose, Throat · 51d
Cleared Nov 01, 1990
OTICAON BTE MODEL E34P
K904673
Oticon Corp.
Ear, Nose, Throat · 20d
Cleared Oct 09, 1990
SERIES MCAXX (MODEL 851) ITE HEARING AID
K903583
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 62d
Cleared Oct 05, 1990
MODEL TRITON 3000 BTE HEARING AID AND PMC SYSTEM
K903760
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 46d