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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 the device name listed in this FDA 510(k) record. The listed applicant is Cochlear. It received FDA 510(k) clearance on 2025-05-29 under 510(k) 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. The listed applicant is Cochlear. The 510(k) number is K250215.

When did Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand receive FDA 510(k) clearance?

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 510(k) number K250215.

Who is the listed applicant for Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand?

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

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

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.

NCT06641999Evaluating 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 RestorationRECRUITINGNCT06894303Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-upRECRUITINGNCT07033130The Performance of Different Sound Paths in Adult NeuroZti CI-usersTERMINATEDNCT07262827Investigating the Acceptance and Performance of Low Energy Audio Streaming in Nucleus 8 and Kanso 3 Sound Processors by Experienced Cochlear Implant UsersRECRUITINGNCT07763873A Study Examining Acceptability of Auditory Implant Fitting Software TechnologiesNOT_YET_RECRUITING

Other records listing Cochlear 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.

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 AppK223672Instrument Case P1340904

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.K243041contact forte AlphaBhm-Tech Produktionsgesellschaft MbhK213733Ponto 5 SuperPowerOticon Medical ABK212136Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart AppCochlear Americas

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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