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510(k) K061459

TRANQUIL TRI-BTE by General Hearing Instruments, Inc. — Product Code KLW

K061459 is an FDA 510(k) premarket notification submitted by General Hearing Instruments, Inc. for the device "TRANQUIL TRI-BTE". The FDA issued a decision of Substantially Equivalent on June 30, 2006. The device falls under product code KLW (Masker, Tinnitus), a Class II device regulated under 21 CFR 874.3400. General Hearing Instruments, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2006
Date Received
May 26, 2006
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 General Hearing Instruments, Inc.

  • K974751 — TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC (March 6, 1998)
  • K971399 — AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC (June 13, 1997)
  • K943144 — AURIS CIC (July 20, 1994)
  • K850123 — IN-TH-EAR HEARING AID (March 21, 1985)

Other clearances for product code KLW

  • K260413 — Levo Gen 2 Tinnitus Therapy System (August 13, 2026)
  • 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)

FDA data resources