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FDA 510(k)

Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App

K-Number: K202048 · 2021-02-23

ApplicantCochlear Americas
Decision Date2021-02-23
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App is the device name listed in this FDA 510(k) record. The listed applicant is Cochlear Americas. It received FDA 510(k) clearance on 2021-02-23 under 510(k) number K202048. The device is classified under product code LXB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App?

Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App is a medical device that received FDA 510(k) clearance on 2021-02-23. The listed applicant is Cochlear Americas. The 510(k) number is K202048.

When did Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App receive FDA 510(k) clearance?

Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App received FDA 510(k) clearance on 2021-02-23, under 510(k) number K202048.

Who is the listed applicant for Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App?

The FDA 510(k) record lists Cochlear Americas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App?

The FDA product code for Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App is LXB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06894303Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-upRECRUITINGNCT03795675CI Following VS Removal or LabyrinthectomyACTIVE_NOT_RECRUITINGNCT06641999Evaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults With Chronic Tinnitus and Varying Levels of Hearing LossRECRUITINGNCT06805175A Study to Evaluate the Safety and Performance of a Vestibular Implant in Adults to Provide Balance RestorationRECRUITINGNCT05451628Anatomy-Based Fitting in Unexperienced Cochlear Implant UsersRECRUITINGNCT07033130The Performance of Different Sound Paths in Adult NeuroZti CI-usersTERMINATED

Other records listing Cochlear Americas as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260902Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3 Charger;Cochlear™ Osia® 3 Aqua+;Cochlear™ Osia® Fitting Software 3;Cochlear™ Osia® Smart App;Cochlear™ Osia® SystemPMA P970051Implant, cochlearPMA P130016Cochlear implant with combined electrical stimulation and acoustic amplificationPMA P000015Implant, auditory brainstemPMA P890027Implant, cochlearPMA P840024Implant, cochlear

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Related Devices (Code: LXB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254296Ossiclear (Ossiclear System)SounductK260452Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)Zdeer Technology (Henan) Co., Ltd.K261256Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)Shenzhen Magnet Technology Co., Ltd.K250215Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBandCochlearK243041contact forte AlphaBhm-Tech Produktionsgesellschaft MbhK213733Ponto 5 SuperPowerOticon Medical AB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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