FDA.reportPublic FDA data

510(k) K250215

Device
Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand
Applicant
Cochlear
510(k) number
K250215
Product code
LXB
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-29
Date received
2025-01-24
Regulation
874.3302
Classification name
Hearing Aid, Bone Conduction
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Denis DiMartino
Address
10350 Park Meadows Dr. Lone Tree CO US 80214 80214

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LXB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243041contact forte AlphaBhm-Tech Produktionsgesellschaft Mbh2025-04-25
K213733Ponto 5 SuperPowerOticon Medical AB2021-12-16
K212136Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart AppCochlear Americas2021-09-29
K211640Ponto 5 MiniOticon Medical AB2021-08-10
K202048Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart AppCochlear Americas2021-02-23
K190540Ponto 4Oticon Medical AB2019-05-02
K172460ADHEAR SystemMed-El Elektromedizinische Geraete GmbH2018-04-27
K171088Cochlear Baha SoundArcCochlear Americas2017-06-07
K161671Ponto 3, Ponto 3 Power and Ponto 3 SuperPowerOticon Medical AB2016-09-29
K153391Sophono Bone Conduction Systems (S) Configuration and (M) ConfigurationSophono, Inc.2016-06-16
K161123Baha 5 Power Sound ProcessorCochlear Americas2016-05-20
K153245Baha 5 Super Power Sound ProcessorCochlear Americas2016-03-02
K150751Cordelle II Sound ProcessorCochlear Americas2015-07-22
K142907Baha 5 Sound ProcessorCochlear Americas2015-03-25
K132775PONTO PLUS AND PONTO PLUS POWEROticon Medical AB2013-12-09