FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K121793 |
AUDIFON-USA INC. |
AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON |
11/01/2012 |
K110996 |
COCHLEAR AMERICAS |
BAHA 3 POWER SOUND PROCESSOR |
05/10/2011 |
K161123 |
Cochlear Americas |
Baha 5 Power Sound Processor |
05/20/2016 |
K142907 |
COCHLEAR AMERICAS |
Baha 5 Sound Processor |
03/25/2015 |
K153245 |
COCHLEAR AMERICAS |
Baha 5 Super Power Sound Processor |
03/02/2016 |
K081606 |
COCHLEAR AMERICAS |
BAHA INTENSO |
08/28/2008 |
K100360 |
COCHLEAR AMERICAS |
BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT |
07/13/2010 |
K132278 |
COCHLEAR AMERICAS |
COCHLEAR BAHA 4 SOUND PROCESSOR |
09/26/2013 |
K202048 |
Cochlear Americas |
Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App |
02/23/2021 |
K212136 |
Cochlear Americas |
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App |
09/29/2021 |
K131240 |
COCHLEAR AMERICAS |
COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT |
11/07/2013 |
K171088 |
Cochlear Americas |
Cochlear Baha SoundArc |
06/07/2017 |
K150751 |
COCHLEAR AMERICAS |
Cordelle II Sound Processor |
07/22/2015 |
K090720 |
COCHLEAR BONE ANCHORED SYSTEMS AB |
COCHLEAR BAHA BP100 |
06/17/2009 |
K062404 |
EAR TECHNOLOGY CORP. |
TRANSEAR BONE CONDUCTION HEARING AID |
09/08/2006 |
K042017 |
ENTIFIC MEDICAL SYSTEMS, INC. |
BAHA DIVINO |
08/26/2004 |
K011438 |
ENTIFIC MEDICAL SYSTEMS, INC. |
BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM. |
07/23/2001 |
K992872 |
ENTIFIC MEDICAL SYSTEMS, INC. |
BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II |
11/24/1999 |
K021837 |
ENTIFIC MEDICAL SYSTEMS, INC. |
BRANENMARK BONE-ANCHORED-HEARING AID (BAHA) |
08/30/2002 |
K002913 |
ENTIFIC MEDICAL SYSTEMS, INC. |
HEADBAND FOR BAHA |
10/17/2000 |
K172460 |
MED-EL Elektromedizinische Geraete GmbH |
ADHEAR System |
04/27/2018 |
K955713 |
NOBELPHARMA USA, INC. |
NOBELPHARMA BONE ANCHORED HEARING AID |
08/09/1996 |
K082108 |
OTICON MEDICAL AB |
OBC BONE ANCHORED HEARING AID SYSTEM |
11/14/2008 |
K161671 |
OTICON MEDICAL AB |
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower |
09/29/2016 |
K190540 |
Oticon Medical AB |
Ponto 4 |
05/02/2019 |
K211640 |
Oticon Medical AB |
Ponto 5 Mini |
08/10/2021 |
K213733 |
Oticon Medical AB |
Ponto 5 SuperPower |
12/16/2021 |
K132775 |
OTICON MEDICAL AB |
PONTO PLUS AND PONTO PLUS POWER |
12/09/2013 |
K090996 |
OTICON MEDICAL AB |
PONTO PRO |
07/29/2009 |
K103594 |
OTICON MEDICAL AB |
PONTO PRO POWER |
06/15/2011 |
K100649 |
SONITUS MEDICAL INC |
SOUNDBITE HEARING SYSTEM BY SONITUS |
01/14/2011 |
K110831 |
SONITUS MEDICAL INC |
SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL |
06/21/2011 |
K153391 |
SOPHONO INC. |
Sophono Bone Conduction Systems (S) Configuration and (M) Configuration |
06/16/2016 |
K132189 |
SOPHONO, INC |
OTOMAG BONE CONDUCATION HEARING SYSTEM |
11/22/2013 |
K100193 |
SOPHONO, INC |
OTOMAG BONE CONDUCTION HEARING SYSTEM |
05/18/2010 |
K123962 |
SOPHONO, INC |
OTOMAG BONE CONDUCTION HEARING SYSTEM |
04/08/2013 |
K102199 |
SOPHONO, INC |
OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M) |
05/23/2011 |
K050653 |
UNITED HEARING SYSTEMS, INC. |
TRANSEAR BONE CONDUCTION HEARING AID |
07/01/2005 |
K953872 |
WORDCOMP INTERNATIONAL COMMUNICATION GROUP (WICG) |
SECOND EAR BONE CONDUCTION HEARING AID |
04/12/1996 |