Telex TDR-4AA Monaural Hear Aid/Wireless FM Rec

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K913494 ↗

FDA Product Code

EPF

Device Class

Class II

Regulation

21 CFR Part 874.3320

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Telex 349 Multi Cros W/Adapive Compression

  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. →

• What is the TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC intended for?

  This device is a monaural hearing aid with wireless FM receiver functionality, designed as a group and auditory trainer for use in clinical or personal settings to assist with hearing assistance and auditory training.

• How is the TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC supplied and prepared for use?

  The device is supplied as a non-sterile, reusable unit, meaning it is not provided in a sterile condition and is intended for multiple uses after appropriate cleaning and maintenance by the user or caregiver.

• What regulatory pathway was used for the TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC, and what is its classification?

  The device received FDA 510(k) clearance under submission K913494, is classified as a Class II medical device with product code EPF, and is subject to special controls under 21 CFR 874.3320 for hearing aids, group and auditory trainers.