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510(k) K181586

Tinnitus Sound Generator Module by GN Hearing A/S — Product Code KLW

K181586 is an FDA 510(k) premarket notification submitted by GN Hearing A/S for the device "Tinnitus Sound Generator Module". The FDA issued a decision of Substantially Equivalent on July 13, 2018. The device falls under product code KLW (Masker, Tinnitus), a Class II device regulated under 21 CFR 874.3400. GN Hearing A/S has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2018
Date Received
June 15, 2018
Clearance Type
Special
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 GN Hearing A/S

  • K254108 — Jabra Enhance Select Self-fit (Jabra Enhance Select 550) (June 25, 2026)
  • K213424 — Jabra Enhance Plus (January 19, 2022)
  • K193303 — Tinnitus Sound Generator Module (February 20, 2020)
  • K180495 — Tinnitus Sound Generator Module (November 30, 2018)

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)
  • K171243 — audifon Tinnitus-Module (October 19, 2017)
  • K163094 — TinniLogic Mobile Tinnitus Management Device (May 17, 2017)

FDA data resources