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FDA 510(k)

Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand

K-Number: K250215 · 2025-05-29

ApplicantCochlear
Decision Date2025-05-29
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand is a medical device manufactured by Cochlear. It received FDA 510(k) clearance on 2025-05-29 under approval number K250215. 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 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand?

Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand is a medical device that received FDA 510(k) clearance on 2025-05-29. It is manufactured by Cochlear. The 510(k) number is K250215.

When was Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand approved by the FDA?

Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand received FDA 510(k) clearance on 2025-05-29, under approval number K250215.

What company makes Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand?

Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand is manufactured by Cochlear.

What is the FDA product code for Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand?

The FDA product code for Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand 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 NCT06100393 New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients. 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

Other Devices by Cochlear

K231204Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App K223672Instrument Case P1340904

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.

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