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510(k) K936190

BEHIND THE EAR HEARING AID by Audina Hearing Instrument — Product Code ESD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1994
Date Received
December 27, 1993
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 Audina Hearing Instrument

  • K964816 — AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR (January 17, 1997)
  • K953960 — HEARING AID (ALL-IN-THE-EAR) (September 12, 1995)
  • K942236 — AUDINA PREWIRES (FACEPLATE HEARING AID SERIES) (June 17, 1994)
  • K930271 — BEHIND-THE-EAR HEARING AID (March 18, 1993)
  • K897024 — MODEL AUDINA ITE HEATING AID (April 18, 1990)
  • K897023 — OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID (March 16, 1990)
  • K820833 — AUDICRAFT VIP HEARING AID (April 9, 1982)

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  • 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)
  • K974069 — OPUS 2 - CANAL SERIES (ITC) (December 15, 1997)