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LXB — Hearing Aid, Bone Conduction Class II

FDA Device Classification

Classification Details

Product Code
LXB
Device Class
Class II
Regulation Number
874.3302
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250215cochlearBaha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS)May 29, 2025
K243041bhm-tech produktionsgesellschaft mbhcontact forte AlphaApril 25, 2025
K213733oticon medicalPonto 5 SuperPowerDecember 16, 2021
K212136cochlear americasCochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha SmaSeptember 29, 2021
K211640oticon medicalPonto 5 MiniAugust 10, 2021
K202048cochlear americasCochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear February 23, 2021
K190540oticon medicalPonto 4May 2, 2019
K172460med-el elektromedizinische geraeteADHEAR SystemApril 27, 2018
K171088cochlear americasCochlear Baha SoundArcJune 7, 2017
K161671oticon medicalPonto 3, Ponto 3 Power and Ponto 3 SuperPowerSeptember 29, 2016
K153391sophonoSophono Bone Conduction Systems (S) Configuration and (M) ConfigurationJune 16, 2016
K161123cochlear americasBaha 5 Power Sound ProcessorMay 20, 2016
K153245cochlear americasBaha 5 Super Power Sound ProcessorMarch 2, 2016
K150751cochlear americasCordelle II Sound ProcessorJuly 22, 2015
K142907cochlear americasBaha 5 Sound ProcessorMarch 25, 2015
K132775oticon medicalPONTO PLUS AND PONTO PLUS POWERDecember 9, 2013
K132189sophonoOTOMAG BONE CONDUCATION HEARING SYSTEMNovember 22, 2013
K131240cochlear americasCOCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACTNovember 7, 2013
K132278cochlear americasCOCHLEAR BAHA 4 SOUND PROCESSORSeptember 26, 2013
K123962sophonoOTOMAG BONE CONDUCTION HEARING SYSTEMApril 8, 2013