Cochlear Baha SoundArc— 510(k) K171088
Substantially EquivalentCochlear Americas
FDA 510(k) clearance K171088 for Cochlear Baha SoundArc, Substantially Equivalent on 2017-06-07. Applicant: Cochlear Americas. Device class: 2.
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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Centennial, CO, US
Recent devices under product code LXB
view all- K253431 — Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)
- K254296 — Ossiclear (Ossiclear System)
- 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)
- K261256 — Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)
- K250215 — Baha 7 Sound Processor +4 more
More clearances from Cochlear Americas
view all- K260902 — Cochlear Osia® 3(I) Sound Processor +6 more
- K240155 — Cochlear Osia System
- K231604 — Instrument Case
- K220922 — Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit
- K212136 — Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
Adverse events under product code LXB
product code LXB- Injury
- 2,334
- Total
- 2,334
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.