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510(k) K161331

HyperSound Tinnitus Module by Turtle Beach Corporation — Product Code KLW

K161331 is an FDA 510(k) premarket notification submitted by Turtle Beach Corporation for the device "HyperSound Tinnitus Module". The FDA issued a decision of Substantially Equivalent on August 23, 2016. The device falls under product code KLW (Masker, Tinnitus), a Class II device regulated under 21 CFR 874.3400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2016
Date Received
May 12, 2016
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

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  • 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)

FDA data resources