Unitron Model Vista 1000 Sigma, Air Conduction Hearing Aid

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K946323 ↗

FDA Product Code

ESD

Device Class

Class I

Regulation

21 CFR Part 874.3300

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Hearing Aid Model E1-Pl

  Class I

  FDA 510(k) K811286 Active Cleared 16 Jun 1981

• Unitron Model Sound F/X Ii

  Class I

  FDA 510(k) K954516 Active Cleared 7 Oct 1995

• Unitron Model UM60-D

  Class I

  FDA 510(k) K853780 Active Cleared 7 Nov 1985

• Hearing Aid, Unitron Model UM60-H

  Class I

  FDA 510(k) K852690 Active Cleared 31 Jul 1985

• Hearing Aid, Unitron Model C5-H

  Class I

  FDA 510(k) K811174 Active Cleared 13 May 1981

• Hearing Aid Model E1-P

  Class I

  FDA 510(k) K811285 Active Cleared 16 Jun 1981

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