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510(k) K944174

LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS by Siemens Hearing Instruments, Inc. — Product Code ESD

K944174 is an FDA 510(k) premarket notification submitted by Siemens Hearing Instruments, Inc. for the device "LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on December 27, 1994. The device falls under product code ESD (Hearing Aid, Air-Conduction, Prescription), a Class I device regulated under 21 CFR 874.3300. Siemens Hearing Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1994
Date Received
August 26, 1994
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)
  • 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)

Other clearances for product code ESD

  • K232999 — Lyric4 Hearing Aid (April 11, 2024)
  • K130790 — LYRIC2 (June 27, 2013)
  • K081136 — LYRIC HEARING AID (May 8, 2008)
  • K021867 — INSOUND XT SERIES HEARING AID (November 19, 2002)
  • K003558 — TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) (April 24, 2001)
  • 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)
  • K974211 — OPUS 2 - FULL CONCHA SERIES - ITE (December 15, 1997)

FDA data resources