510(k) K212136
- Device
- Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
- Applicant
- Cochlear Americas
- 510(k) number
- K212136
- Product code
- LXB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-09-29
- Date received
- 2021-07-08
- Regulation
- 874.3300
- Classification name
- Hearing Aid, Bone Conduction
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Whitney Alexander
- Address
- 10350 Park Meadows Dr. Lone Tree CO US 80124 80124
FDA Registration Numbers#
- 3010097171
- 3014990990
- 9612468
- 3007743836
- 3027588012
- 9616024
- 3005150478
- 3014579188
- 3043654373
- 1045254
- 3007367732
- 3033905868
- 3007275459
- 3012593436
- 3013177549
- 3006405073
- 9710014
- 3034209804
- 9613646
- 8031010
- 3005900820
- 3009632672
- 3010376846
- 3003477135
- 3009307953
- 3020283264
- 3005216725
- 3007689689
- 3018094310
- 3009092818
- 3005820796
- 3003847101
Source Documents#
Other 510(k) Records For Product Code LXB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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) | Zdeer Technology (Henan) Co., Ltd. | 2026-06-15 |
| K261256 | Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) | Shenzhen Magnet Technology Co., Ltd. | 2026-06-11 |
| K250215 | Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand | Cochlear | 2025-05-29 |
| K243041 | contact forte Alpha | Bhm-Tech Produktionsgesellschaft Mbh | 2025-04-25 |
| K213733 | Ponto 5 SuperPower | Oticon Medical AB | 2021-12-16 |
| K211640 | Ponto 5 Mini | Oticon Medical AB | 2021-08-10 |
| K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App | Cochlear Americas | 2021-02-23 |
| K190540 | Ponto 4 | Oticon Medical AB | 2019-05-02 |
| K172460 | ADHEAR System | Med-El Elektromedizinische Geraete GmbH | 2018-04-27 |
| K171088 | Cochlear Baha SoundArc | Cochlear Americas | 2017-06-07 |
| K161671 | Ponto 3, Ponto 3 Power and Ponto 3 SuperPower | Oticon Medical AB | 2016-09-29 |
| K153391 | Sophono Bone Conduction Systems (S) Configuration and (M) Configuration | Sophono, Inc. | 2016-06-16 |
| K161123 | Baha 5 Power Sound Processor | Cochlear Americas | 2016-05-20 |
| K153245 | Baha 5 Super Power Sound Processor | Cochlear Americas | 2016-03-02 |
| K150751 | Cordelle II Sound Processor | Cochlear Americas | 2015-07-22 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases