Mis Aural Acoustic Screener

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K791170 ↗

FDA Product Code

EWO

Device Class

Class II

Regulation

21 CFR Part 874.1050

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESP Substantially Equivalent — Postmarket Surveillance

• Faceplate, Custom in-the-Ear Hearing Aid, Fpr

  Class I

  FDA 510(k) K862769 Active Cleared 13 Aug 1986

• Hearing Aid, Series R

  Class I

  FDA 510(k) K770960 Active Cleared 14 Jun 1977

• Series M Push-Pull Input Compression

  Class I

  FDA 510(k) K821760 Active Cleared 25 Jun 1982

• Model P20/P21 in-the-Ear Hearing Aid

  Class I

  FDA 510(k) K882692 Active Cleared 15 Jul 1988

• Maico MA800 Audiometer

  Class II

  FDA 510(k) K911368 Active Cleared 26 Jun 1991

• Ma 610-Impedance Audiometer

  Class II

  FDA 510(k) K831754 Active Cleared 7 Jul 1983

See all devices from Maico Hearing Instruments, Inc. →