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510(k) K820833

AUDICRAFT VIP HEARING AID by Audina Hearing Instrument — Product Code ESD

K820833 is an FDA 510(k) premarket notification submitted by Audina Hearing Instrument for the device "AUDICRAFT VIP HEARING AID". The FDA issued a decision of Substantially Equivalent on April 9, 1982. The device falls under product code ESD (Hearing Aid, Air-Conduction, Prescription), a Class I device regulated under 21 CFR 874.3300. Audina Hearing Instrument has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1982
Date Received
March 26, 1982
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)
  • K936190 — BEHIND THE EAR HEARING AID (April 4, 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)

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