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510(k) K202048

Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App by Cochlear Americas — Product Code LXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2021
Date Received
July 24, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hearing Aid, Bone Conduction
Device Class
Class II
Regulation Number
874.3302
Review Panel
EN
Submission Type

Other clearances by Cochlear Americas

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  • K231604 — Instrument Case (August 24, 2023)
  • K220922 — Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Proc (July 27, 2022)
  • K212136 — Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Sma (September 29, 2021)
  • K191921 — Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Soft (November 15, 2019)
  • K190589 — Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative (July 3, 2019)
  • K182116 — BA310 Abutment, BIA310 Implant/Abutment (December 19, 2018)
  • K171088 — Cochlear Baha SoundArc (June 7, 2017)
  • K161123 — Baha 5 Power Sound Processor (May 20, 2016)
  • K153245 — Baha 5 Super Power Sound Processor (March 2, 2016)

Other clearances for product code LXB

  • K250215 — Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (May 29, 2025)
  • K243041 — contact forte Alpha (April 25, 2025)
  • K213733 — Ponto 5 SuperPower (December 16, 2021)
  • K212136 — Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Sma (September 29, 2021)
  • K211640 — Ponto 5 Mini (August 10, 2021)
  • K190540 — Ponto 4 (May 2, 2019)
  • K172460 — ADHEAR System (April 27, 2018)
  • K171088 — Cochlear Baha SoundArc (June 7, 2017)
  • K161671 — Ponto 3, Ponto 3 Power and Ponto 3 SuperPower (September 29, 2016)
  • K153391 — Sophono Bone Conduction Systems (S) Configuration and (M) Configuration (June 16, 2016)