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FDA 510(k)

Baha 5 Power Sound Processor

K-Number: K161123 · 2016-05-20

ApplicantCochlear Americas
Decision Date2016-05-20
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Baha 5 Power Sound Processor is a medical device manufactured by Cochlear Americas. It received FDA 510(k) clearance on 2016-05-20 under approval number K161123. 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 Baha 5 Power Sound Processor?

Baha 5 Power Sound Processor is a medical device that received FDA 510(k) clearance on 2016-05-20. It is manufactured by Cochlear Americas. The 510(k) number is K161123.

When was Baha 5 Power Sound Processor approved by the FDA?

Baha 5 Power Sound Processor received FDA 510(k) clearance on 2016-05-20, under approval number K161123.

What company makes Baha 5 Power Sound Processor?

Baha 5 Power Sound Processor is manufactured by Cochlear Americas.

What is the FDA product code for Baha 5 Power Sound Processor?

The FDA product code for Baha 5 Power Sound Processor is LXB.

Related Clinical Trials

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 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 NCT03795675 CI Following VS Removal or Labyrinthectomy ACTIVE_NOT_RECRUITING NCT07582198 Hearing Outcomes With the Nucleus® 8 Sound Processor and Nucleus® 7 Sound Processor in Adult Veteran and Non-veteran Cochlear Implant Recipients NOT_YET_RECRUITING NCT07139327 A Pivotal Study to Evaluate the Efficacy and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults ACTIVE_NOT_RECRUITING

Other Devices by Cochlear Americas

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 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. K153245Baha 5 Super Power Sound ProcessorCochlear Americas K171088Cochlear Baha SoundArcCochlear 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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