Home / 510(k) Clearances / K121317

510(k) K121317

COCHLEAR BAHA IMPLANT SYSTEM by Cochlear Americas — Product Code MAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2012
Date Received
May 2, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hearing Aid, Bone Conduction, Implanted
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)
  • 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 MAH

  • K203807 — Ponto Bone Anchored Hearing System, MONO Surgery Kit (March 3, 2021)
  • K182116 — BA310 Abutment, BIA310 Implant/Abutment (December 19, 2018)
  • K152820 — Ponto Bone Anchored Hearing System (January 22, 2016)
  • K152067 — Ponto bone anchored hearing system (November 23, 2015)
  • K150555 — BA400 14mm Abutment (July 15, 2015)
  • K142678 — Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing (January 21, 2015)
  • K121228 — PONTO BONE ANCHORED HEARING SYSTEM (September 7, 2012)
  • K112053 — OBC BONE ANCHORED HEARING SYSTEM (November 18, 2011)
  • K080363 — BAHA CORDELLE II (April 10, 2008)
  • K984162 — BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE (June 28, 1999)