Home / 510(k) Clearances / K212136

510(k) K212136

Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App by Cochlear Americas — Product Code LXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2021
Date Received
July 8, 2021
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

  • K240155 — Cochlear Osia System (April 18, 2024)
  • K231604 — Instrument Case (August 24, 2023)
  • K220922 — Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Proc (July 27, 2022)
  • K202048 — Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear (February 23, 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)
  • K211640 — Ponto 5 Mini (August 10, 2021)
  • K202048 — Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear (February 23, 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)