510(k) K946323

UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID by Unitron Industries, Inc. — Product Code ESD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 30, 1995
Date Received: December 29, 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 Unitron Industries, Inc.

K974339 — UNITRON MODEL SOUND F/XD PROGRAMMABLE (December 12, 1997)
K974338 — UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) (December 12, 1997)
K974340 — UNITRON MODEL SOUND F/XP 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)
K964511 — UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4) (November 27, 1996)
K964510 — UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4) (November 27, 1996)
K964508 — UNITRON MODEL ICON AOHP +4 (ICON AOHP +4) (November 27, 1996)
K964503 — UNITRON MODEL SOUND F/X +4 (November 27, 1996)
K964502 — UNITRON MODEL SOUND F/XP +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)
K974069 — OPUS 2 - CANAL SERIES (ITC) (December 15, 1997)