Atlas FDA

Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App

FDA 510(k) clearance K202048 · decided 2021-02-23

Clearance details

K-number
K202048
Device name
Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App
Applicant
Cochlear Americas
Decision
Substantially Equivalent
Date received
2020-07-24
Decision date
2021-02-23
Days to decision
214 days
Clearance type
Traditional
Product code
LXB
Device class
2
Regulation number
874.3302
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
Lone Tree, CO, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Ossiclear (Ossiclear System) (K254296)Sounduct2026-07-22
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) (K260452)Zdeer Technology (Henan) Co., Ltd.2026-06-15
Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) (K261256)Shenzhen Magnet Technology Co., Ltd.2026-06-11
Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand (K250215)Cochlear2025-05-29
contact forte Alpha (K243041)Bhm-Tech Produktionsgesellschaft Mbh2025-04-25
Ponto 5 SuperPower (K213733)Oticon Medical AB2021-12-16
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App (K212136)Cochlear Americas2021-09-29
Ponto 5 Mini (K211640)Oticon Medical AB2021-08-10
Ponto 4 (K190540)Oticon Medical AB2019-05-02
ADHEAR System (K172460)Med-El Elektromedizinische Geraete GmbH2018-04-27
Cochlear Baha SoundArc (K171088)Cochlear Americas2017-06-07
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower (K161671)Oticon Medical AB2016-09-29

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S240)Cochlear Americas2025-12-19
Nucleus® Hybrid™ L24 Cochlear Implant System (P130016/S058)Cochlear Americas2025-10-16
Nucleus® 24 Cochlear Implant System (P970051/S236)Cochlear Americas2025-10-16
Nucleus® 24 Cochlear Implant System (P970051/S238)Cochlear Americas2025-09-26
Cochlear™ Nucleus® System (P970051/S237)Cochlear Americas2025-09-02
Nucleus® 24 Cochlear Implant System (P970051/S235)Cochlear Americas2025-08-06
Nucleus® 24 Cochlear Implant System (P970051/S234)Cochlear Americas2025-07-24
Nucleus® 22 Cochlear Implant System (P890027/S064)Cochlear Americas2025-07-03