Home / 510(k) Clearances / K153391

510(k) K153391

Sophono Bone Conduction Systems (S) Configuration and (M) Configuration by Sophono, Inc. — Product Code LXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2016
Date Received
November 24, 2015
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 Sophono, Inc.

  • K132189 — OTOMAG BONE CONDUCATION HEARING SYSTEM (November 22, 2013)
  • K123962 — OTOMAG BONE CONDUCTION HEARING SYSTEM (April 8, 2013)
  • K102199 — OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M) (May 23, 2011)
  • K100193 — OTOMAG BONE CONDUCTION HEARING SYSTEM (May 18, 2010)

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)
  • 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)