Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
FDA 510(k) K212136 · Cochlear Americas
510(k) numberK212136
Submission
- Device name
- Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
- Applicant
- Cochlear Americas
Lone Tree, CO, US - Received
- July 8, 2021
- Decision date
- September 29, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K250215 | Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS)…LXB · Traditional | Cochlear | 05/29/2025SE |
| K243041 | contact forte AlphaLXB · Traditional | Bhm-Tech Produktionsgesellschaft Mbh | 04/25/2025SE |
| K213733 | Ponto 5 SuperPowerLXB · Special | Oticon Medical AB | 12/16/2021SE |
| 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 |
|---|---|---|
| K260902 | Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear Osia® 3…PFO · Traditional | 07/10/2026SE |
| K240155 | Cochlear Osia SystemPFO · Traditional | 04/18/2024SE |
| K231604 | Instrument CaseKCT · Special | 08/24/2023SE |
| K220922 | Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor…PFO · Traditional | 07/27/2022SE |
| K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha…LXB · Traditional | 02/23/2021SE |
| K191921 | Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software…PFO · Traditional | 11/15/2019SE |
| K190589 | Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test…PFO · Traditional | 07/03/2019SE |
| K182116 | BA310 Abutment, BIA310 Implant/AbutmentMAH · Traditional | 12/19/2018SE |
| K171088 | Cochlear Baha SoundArcLXB · Special | 06/07/2017SE |
| K161123 | Baha 5 Power Sound ProcessorLXB · Special | 05/20/2016SE |
Questions and answers
When was Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App cleared by the FDA?
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App (K212136) received a 510(k) decision of Substantially Equivalent on September 29, 2021, 83 days after the submission was received.
What is the product code of K212136?
The FDA product code is LXB – Hearing Aid, Bone Conduction, a Class II (moderate risk) device regulated under 21 CFR 874.3302.