FDA 510(k)

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

K-Number: K202048 · 2021-02-23

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 a medical device manufactured by Cochlear Americas. It received FDA 510(k) clearance on 2021-02-23 under approval 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. It is manufactured by Cochlear Americas. The 510(k) number is K202048.

When was Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App approved by the FDA?

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 approval number K202048.

What company makes 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 manufactured by Cochlear Americas.

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

NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT07262827 Investigating the Acceptance and Performance of Low Energy Audio Streaming in Nucleus 8 and Kanso 3 Sound Processors by Experienced Cochlear Implant Users RECRUITING NCT07287124 A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults RECRUITING NCT07033130 The Performance of Different Sound Paths in Adult NeuroZti CI-users TERMINATED NCT06894303 Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up RECRUITING NCT05709223 Comparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant 3 Months Post-activation COMPLETED

Other Devices by Cochlear Americas

K161123Baha 5 Power Sound Processor K153245Baha 5 Super Power Sound Processor K171088Cochlear Baha SoundArc K182116BA310 Abutment, BIA310 Implant/Abutment K191921Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments K190589Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments

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Related Devices (Code: LXB)

K161671Ponto 3, Ponto 3 Power and Ponto 3 SuperPowerOticon Medical AB K153391Sophono Bone Conduction Systems (S) Configuration and (M) ConfigurationSophono, Inc. K161123Baha 5 Power Sound ProcessorCochlear Americas K153245Baha 5 Super Power Sound ProcessorCochlear Americas K171088Cochlear Baha SoundArcCochlear Americas K172460ADHEAR SystemMed-El Elektromedizinische Geraete GmbH

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.