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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号: K250215 · 2025-05-29

申请人Cochlear
决定日期2025-05-29
产品代码LXB
咨询委员会医疗设备监管文本描述翻译如下： 关于[公司/产品名称]的监管信息： - 美国食品药品监督管理局（FDA）批准号：[510(k)编号] - 预市场批准（PMA）申请号：[PMA编号] - 临床试验注册号（NCT）：[NCT编号] - 医学文献标识符（PMID）：[PMID编号] - 产品标识符：[标识符] - 相关政策：医疗监管政策v1 - 更多信息请访问：[URL] 请注意，以上翻译保留了公司/产品名称、FDA、510(k)、PMA、NCT、PMID、标识符和URL。
决定实质等同

器械摘要

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.

常见问题

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.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Cochlear为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K231204Cochlear® Osia®系统；Cochlear® Osia® OSI300植入器；Cochlear®磁带；Cochlear®非磁性磁带；Cochlear® Osia® 2(I)声音处理器；Cochlear® Osia®适配软件2；Cochlear® Osia®智能应用K223672Instrument Case P1340904

相关器械（代码：LXB）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253431骨传导助听器（BM100、BM300、BM310、SHOKZHEAR BM400、SHOKZ BM400MN、SHOKZHEAR BM410、SHOKZHEAR BM410MN、SHOKZHEAR BM420和SHOKZHEAR BM420MN）Shokz Health Global LimitedK254296Ossiclear（Ossiclear 系统）SounductK260452骨传导助听器 (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.K261256骨传导助听器 (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)Shenzhen Magnet Technology Co., Ltd.K243041联系强特AlphaBhm-Tech Produktionsgesellschaft MbhK213733Ponto 5 SuperPowerOticon Medical AB

官方来源

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