Home / 510(k) Clearances / K954430

510(k) K954430

UNITRON MODEL SOUND F/X by Unitron Industries, Inc. — Product Code ESD

K954430 is an FDA 510(k) premarket notification submitted by Unitron Industries, Inc. for the device "UNITRON MODEL SOUND F/X". The FDA issued a decision of Substantially Equivalent on October 6, 1995. The device falls under product code ESD (Hearing Aid, Air-Conduction, Prescription), a Class I device regulated under 21 CFR 874.3300. Unitron Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1995
Date Received
September 22, 1995
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 Unitron Industries, Inc.

  • K974339 — UNITRON MODEL SOUND F/XD PROGRAMMABLE (December 12, 1997)
  • K974340 — UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE (December 12, 1997)
  • K974338 — UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) (December 12, 1997)
  • K970692 — UNITRON MODEL SOUND F/X CIC (May 8, 1997)
  • K970519 — UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE) (April 24, 1997)
  • K964503 — UNITRON MODEL SOUND F/X +4 (November 27, 1996)
  • K964510 — UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4) (November 27, 1996)
  • K964502 — UNITRON MODEL SOUND F/XP +4 (November 27, 1996)
  • K964508 — UNITRON MODEL ICON AOHP +4 (ICON AOHP +4) (November 27, 1996)
  • K964504 — UNITRON MODEL ICON AOHPL +4 (November 27, 1996)

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