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510(k) K011364

CUSTOM TCI (TINNITUS CONTROL INSTRUMENT) by Siemens Hearing Instruments, Inc. — Product Code KLW

K011364 is an FDA 510(k) premarket notification submitted by Siemens Hearing Instruments, Inc. for the device "CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)". The FDA issued a decision of Substantially Equivalent on June 7, 2001. The device falls under product code KLW (Masker, Tinnitus), a Class II device regulated under 21 CFR 874.3400. Siemens Hearing Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2001
Date Received
May 4, 2001
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 Siemens Hearing Instruments, Inc.

  • K071462 — UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) (June 5, 2007)
  • K011366 — CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) (June 1, 2001)
  • K003559 — TCI (TINNITUS CONTROL INSTRUMENT) (April 26, 2001)
  • K003558 — TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) (April 24, 2001)
  • K972998 — PRISMA (September 5, 1997)
  • K962170 — SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP (July 25, 1996)
  • K952940 — PERSONAL PROGRAMMER 2000 (July 26, 1995)
  • K951828 — FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT (June 30, 1995)
  • K952263 — PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT (June 5, 1995)
  • K951896 — INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARIN (May 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