Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App— 510(k) K212136

Clearance details

Applicant

Cochlear Americas

Product code

Code LXB

Device class

Class 2

Regulation

21 CFR 874.3302

Advisory panel

Ear, Nose, Throat

Date received

2021-07-08

Decision date

2021-09-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lone Tree, CO, US

• K253431 — Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)2026-08-19
• K254296 — Ossiclear (Ossiclear System)2026-07-22
• K260452 — Bone 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)2026-06-15
• K261256 — Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)2026-06-11
• K250215 — Baha 7 Sound Processor +4 more2025-05-29

• K260902 — Cochlear Osia® 3(I) Sound Processor +6 more2026-07-10
• K240155 — Cochlear Osia System2024-04-18
• K231604 — Instrument Case2023-08-24
• K220922 — Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit2022-07-27
• K202048 — Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App2021-02-23

Injury

2,334

Total

2,334

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →