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510(k) K973880

SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM by Sonix Technologies, Inc. — Product Code ESD

K973880 is an FDA 510(k) premarket notification submitted by Sonix Technologies, Inc. for the device "SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM". The FDA issued a decision of Substantially Equivalent on January 12, 1998. The device falls under product code ESD (Hearing Aid, Air-Conduction, Prescription), a Class I device regulated under 21 CFR 874.3300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1998
Date Received
October 14, 1997
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 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)
  • K974211 — OPUS 2 - FULL CONCHA SERIES - ITE (December 15, 1997)
  • K974069 — OPUS 2 - CANAL SERIES (ITC) (December 15, 1997)

FDA data resources