Digital Lgob Procedure Using Resound, Digital 5000 Series Hearing Aids

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

510(k) Number

K984547 ↗

FDA Product Code

EWO

Device Class

Class II

Regulation

21 CFR Part 874.1050

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Hearing Aid - Air Conduction

  Class I

  FDA 510(k) K960684 Active Cleared 10 Apr 1996

• Resound(R) Personal Hearing System Ed-3 Encore

  Class I

  FDA 510(k) K950319 Active Cleared 8 Feb 1995

• Resound Personal Hearing Systems Modification

  Class I

  FDA 510(k) K934917 Active Cleared 19 Jan 1995

• Resound Personal Hearing System ED3/S-E

  Class I

  FDA 510(k) K951375 Active Cleared 14 Apr 1995

• Resound Digital 2000-Bt W/Digital 2000-Df (Digital Programmer)

  Class I

  FDA 510(k) K974257 Active Cleared 12 Dec 1997

• Resound BT4 Personal Hearing System W/Remote Control Option

  Class I

  FDA 510(k) K964557 Active Cleared 27 Nov 1996

See all devices from Resound Corp. →