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510(k) K110996

BAHA 3 POWER SOUND PROCESSOR by Cochlear Americas — Product Code LXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2011
Date Received
April 11, 2011
Clearance Type
Special
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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  • K212136 — Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Sma (September 29, 2021)
  • 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)

Other clearances for product code LXB

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  • 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)
  • 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)