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

Q: What is the product code of K250215?

The FDA product code is LXB – Hearing Aid, Bone Conduction, a Class II (moderate risk) device regulated under 21 CFR 874.3302.

FDA 510(k) K250215 · Cochlear

Substantially Equivalent

510(k) numberK250215

Submission

Device name: Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand
Applicant: Cochlear
Lone Tree, CO, US
Received: January 24, 2025
Decision date: May 29, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LXB – Hearing Aid, Bone Conduction
Device class: Class II (moderate risk)
Regulation: 21 CFR 874.3302
Specialty: Ear, Nose, Throat

Other 510(k)s with product code LXB

510(k)	Device	Applicant	Decision
K253431	Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN…LXB · Traditional	Shokz Health Global Limited	08/19/2026SE
K254296	Ossiclear (Ossiclear System)LXB · Traditional	Sounduct	07/22/2026SE
K260452	Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153…LXB · Traditional	Zdeer Technology (Henan) Co., Ltd.	06/15/2026SE
K261256	Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)LXB · Traditional	Shenzhen Magnet Technology Co., Ltd.	06/11/2026SE
K243041	contact forte AlphaLXB · Traditional	Bhm-Tech Produktionsgesellschaft Mbh	04/25/2025SE
K213733	Ponto 5 SuperPowerLXB · Special	Oticon Medical AB	12/16/2021SE
K212136	Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart AppLXB · Traditional	Cochlear Americas	09/29/2021SE
K211640	Ponto 5 MiniLXB · Special	Oticon Medical AB	08/10/2021SE
K202048	Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha…LXB · Traditional	Cochlear Americas	02/23/2021SE
K190540	Ponto 4LXB · Traditional	Oticon Medical AB	05/02/2019SE

More from Oticon Medical AB

510(k)	Device	Decision
K231204	Cochlear Osia® System; Cochlear Osia® OSI300 Implant; Cochlear Magnet Cassette…PFO · Traditional	08/18/2023SE
K223672	Instrument Case P1340904KCT · Traditional	03/21/2023SE

Questions and answers

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

Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand (K250215) received a 510(k) decision of Substantially Equivalent on May 29, 2025, 125 days after the submission was received.

What is the product code of K250215?

The FDA product code is LXB – Hearing Aid, Bone Conduction, a Class II (moderate risk) device regulated under 21 CFR 874.3302.