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FDA 510(k)

Cochlear Baha SoundArc

K-Number: K171088 · 2017-06-07

ApplicantCochlear Americas
Decision Date2017-06-07
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Cochlear Baha SoundArc is a medical device manufactured by Cochlear Americas. It received FDA 510(k) clearance on 2017-06-07 under approval number K171088. 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 SoundArc?

Cochlear Baha SoundArc is a medical device that received FDA 510(k) clearance on 2017-06-07. It is manufactured by Cochlear Americas. The 510(k) number is K171088.

When was Cochlear Baha SoundArc approved by the FDA?

Cochlear Baha SoundArc received FDA 510(k) clearance on 2017-06-07, under approval number K171088.

What company makes Cochlear Baha SoundArc?

Cochlear Baha SoundArc is manufactured by Cochlear Americas.

What is the FDA product code for Cochlear Baha SoundArc?

The FDA product code for Cochlear Baha SoundArc is LXB.

Other Devices by Cochlear Americas

K161123Baha 5 Power Sound Processor K153245Baha 5 Super Power Sound Processor 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 K212136Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App

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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 K172460ADHEAR SystemMed-El Elektromedizinische Geraete GmbH K190540Ponto 4Oticon 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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