TDR-4 Monaural Hearing Aid/Wireless FM Receiver

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K915383 ↗

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 TDR-4 Monaural Hearing Aid/Wireless FM Receiver used for?

  The TDR-4 is designed specifically for individuals with unilateral hearing loss. It functions as both a monaural hearing aid and a wireless FM receiver, amplifying sound and enabling clear audio transmission from a separate FM transmitter. This dual functionality helps users in challenging listening environments, such as classrooms or public spaces, by providing direct and focused auditory access.

• Is the TDR-4 a single-use or reusable device?

  The TDR-4 is a reusable device. It is not intended for one-time use but rather for ongoing clinical or home use by audiologists, ENT specialists, or trained hearing care professionals. Proper cleaning and maintenance are required to ensure continued functionality and hygiene.

• What type of environment should the TDR-4 be stored in?

  The TDR-4 must be stored in a clean, dry environment to maintain its functionality. Avoid exposure to moisture, extreme temperatures, or dust, as these conditions can compromise the device’s performance or longevity. Regular inspection for physical damage is also recommended.

• Does the TDR-4 have any special MRI safety considerations?

  The device documentation does not specify any MRI safety information for the TDR-4. Users should consult the manufacturer’s guidelines or contact Telex Communications directly if MRI exposure is a concern, as improper handling near MRI machines could pose risks.

• Who is authorized to use or prescribe the TDR-4?

  The TDR-4 is intended for use in clinical and home settings by qualified professionals, including audiologists and ENT specialists. While it can also be used by trained hearing care professionals, its prescription or fitting should ideally be overseen by a licensed clinician to ensure proper customization and benefit for the user.