LXB · Class II · 21 CFR 874.3302

FDA Product Code LXB: Hearing Aid, Bone Conduction

Leading manufacturers include Cochlear Americas, Oticon Medical AB and Xomed, Inc..

53
Total
53
Cleared
120d
Avg days
1986
Since
53 devices
25–48 of 53
Cleared Nov 01, 2012
AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON
K121793
Audifon-USA, Inc.
Ear, Nose, Throat · 135d
Cleared Jun 21, 2011
SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL
K110831
Sonitus Medical, Inc.
Ear, Nose, Throat · 88d
Cleared Jun 15, 2011
PONTO PRO POWER
K103594
Oticon Medical AB
Ear, Nose, Throat · 189d
Cleared May 10, 2011
BAHA 3 POWER SOUND PROCESSOR
K110996
Cochlear Americas
Ear, Nose, Throat · 29d
Cleared Jul 13, 2010
BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT
K100360
Cochlear Americas
Ear, Nose, Throat · 151d
Cleared Jul 29, 2009
PONTO PRO
K090996
Oticon Medical AB
Ear, Nose, Throat · 112d
Cleared Nov 14, 2008
OBC BONE ANCHORED HEARING AID SYSTEM
K082108
Oticon Medical AB
Ear, Nose, Throat · 112d
Cleared Aug 28, 2008
BAHA INTENSO
K081606
Cochlear Americas
Ear, Nose, Throat · 83d
Cleared Sep 08, 2006
TRANSEAR BONE CONDUCTION HEARING AID
K062404
Ear Technology Corp.
Ear, Nose, Throat · 22d
Cleared Jul 01, 2005
TRANSEAR BONE CONDUCTION HEARING AID
K050653
United Hearing Systems, Inc.
Ear, Nose, Throat · 112d
Cleared Aug 26, 2004
BAHA DIVINO
K042017
Entific Medical Systems, Inc.
Ear, Nose, Throat · 30d
Cleared Nov 24, 1999
BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II
K992872
Entific Medical Systems, Inc.
Ear, Nose, Throat · 90d
Cleared Aug 09, 1996
NOBELPHARMA BONE ANCHORED HEARING AID
K955713
Nobelpharma USA, Inc.
Ear, Nose, Throat · 235d
Cleared Apr 12, 1996
SECOND EAR BONE CONDUCTION HEARING AID
K953872
Wordcomp International Communication Group (Wicg)
Ear, Nose, Throat · 239d
Cleared May 10, 1994
VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229
K935701
Starkey Laboratories, Inc.
Ear, Nose, Throat · 161d
Cleared Nov 30, 1988
MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR
K884056
Xomed, Inc.
Ear, Nose, Throat · 65d
Cleared Jun 21, 1988
XOMED AUDIANT BONE CONDUCTOR
K881382
Xomed, Inc.
Ear, Nose, Throat · 81d
Cleared Mar 14, 1988
ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON.
K875277
Xomed, Inc.
Ear, Nose, Throat · 81d
Cleared Jun 30, 1987
XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO.
K872168
Xomed, Inc.
Ear, Nose, Throat · 22d
Cleared May 30, 1986
XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL
K861971
Xomed, Inc.
Ear, Nose, Throat · 9d
Cleared Apr 03, 1986
AUDIANT BONE CONDUCTOR OR A.B.C.
K855059
Xomed, Inc.
Ear, Nose, Throat · 106d