Telex Tdr-7AA Binaural Hear Aid/Wireless Fm Rec

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K913495 ↗

FDA Product Code

EPF

Device Class

Class II

Regulation

21 CFR Part 874.3320

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K954579 Active Cleared 8 Dec 1995

• TDR-4S Monaural Hearing Aid/Wireless FM Receiver

  Class II

  FDA 510(k) K915384 Active Cleared 17 Jan 1992

• Faceplate Ite Hearing Aid Model 28A

  Class I

  FDA 510(k) K910901 Active Cleared 30 May 1991

• Hearing Aid 365

  Class I

  FDA 510(k) K850243 Active Cleared 25 Mar 1985

• Telex in-the-Ear Custom Hearing Aid with Threshold Compression

  Class I

  FDA 510(k) K963915 Active Cleared 8 Nov 1996

• Telex Select 1-40 with Adaptive Compression

  Class II

  FDA 510(k) K982683 Active Cleared 6 Oct 1998

See all devices from Telex Communications, Inc. →