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510(k) K003558

TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) by Siemens Hearing Instruments, Inc. — Product Code ESD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2001
Date Received
November 17, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hearing Aid, Air-Conduction, Prescription
Device Class
Class I
Regulation Number
874.3300
Review Panel
EN
Submission Type

An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is a prescription hearing aid.

Other clearances by Siemens Hearing Instruments, Inc.

  • K071462 — UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) (June 5, 2007)
  • K011364 — CUSTOM TCI (TINNITUS CONTROL INSTRUMENT) (June 7, 2001)
  • K011366 — CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) (June 1, 2001)
  • K003559 — TCI (TINNITUS CONTROL INSTRUMENT) (April 26, 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)

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  • K021867 — INSOUND XT SERIES HEARING AID (November 19, 2002)
  • K984518 — SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL (March 12, 1999)
  • K974751 — TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC (March 6, 1998)
  • K974242 — ARGOSY PROGRAMMABLE ONQUE (January 20, 1998)
  • K973880 — SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM (January 12, 1998)
  • K974069 — OPUS 2 - CANAL SERIES (ITC) (December 15, 1997)
  • K974211 — OPUS 2 - FULL CONCHA SERIES - ITE (December 15, 1997)