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510(k) K133308

TINNITUS SOUNDSUPPORT by Oticon A/S — Product Code KLW

K133308 is an FDA 510(k) premarket notification submitted by Oticon A/S for the device "TINNITUS SOUNDSUPPORT". The FDA issued a decision of Substantially Equivalent on March 18, 2014. The device falls under product code KLW (Masker, Tinnitus), a Class II device regulated under 21 CFR 874.3400. Oticon A/S has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2014
Date Received
October 28, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Masker, Tinnitus
Device Class
Class II
Regulation Number
874.3400
Review Panel
EN
Submission Type

Other clearances by Oticon A/S

  • K973886 — OTICON DIGISOUND COMPACT (November 4, 1997)
  • K973885 — OTICON DIGISOUND ITE (November 4, 1997)
  • K964683 — DIGIFOCUS ITE (December 12, 1996)
  • K963788 — PRIMOFOCUS COMPACT (November 27, 1996)
  • K961059 — DIGIFOCUS COMPACT (May 7, 1996)
  • K960284 — OTICON /PRIMOFOCUS (PF) (March 7, 1996)
  • K954794 — OTICON (November 13, 1995)
  • K951002 — AMENDMENTS TO MULTIFOCUS (September 18, 1995)
  • K950381 — OTICON/LOGIC (February 27, 1995)
  • K946045 — OTICON (January 30, 1995)

Other clearances for product code KLW

  • K260614 — Tinnitus Therapy (June 10, 2026)
  • K233435 — Peace N Quiet (0.7.0) (February 27, 2024)
  • K223694 — Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) (June 30, 2023)
  • K221168 — Tinnitogram Signal Generator (February 1, 2023)
  • K221125 — SilentCloud (January 4, 2023)
  • K201370 — Multiflex Tinnitus Technology (June 19, 2020)
  • K193303 — Tinnitus Sound Generator Module (February 20, 2020)
  • K180495 — Tinnitus Sound Generator Module (November 30, 2018)
  • K181586 — Tinnitus Sound Generator Module (July 13, 2018)
  • K171243 — audifon Tinnitus-Module (October 19, 2017)

FDA data resources