TDR-4S Monaural Hearing Aid/Wireless FM Receiver

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

510(k) Number

K915384 ↗

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

• 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

• Model 353C Hearing Aid

  Class I

  FDA 510(k) K860035 Active Cleared 17 Mar 1986

See all devices from Telex Communications, Inc. →

• What is the TDR-4S Monaural Hearing Aid/Wireless FM Receiver designed for?

  The TDR-4S is specifically designed for individuals with unilateral hearing loss to amplify sound and improve clarity in challenging listening environments. Its wireless FM technology enhances signal transmission from a remote microphone or audio source, making it ideal for settings such as classrooms, meetings, or public spaces where background noise can interfere with communication.

• Is the TDR-4S intended for single-use or reusable clinical applications?

  The TDR-4S is supplied as a reusable, non-sterile medical instrument. It is intended for clinical use in Ear, Nose, and Throat (ENT) settings, where it can be utilized repeatedly for patients requiring hearing assistance. Reusability is a key feature, but proper cleaning and maintenance are essential to ensure functionality and hygiene.

• What storage conditions are required to maintain the device’s functionality?

  The TDR-4S must be stored in a clean, dry environment to preserve its performance. Avoid exposure to moisture, extreme temperatures, or direct sunlight, as these conditions can degrade components over time. Additionally, since the device is not MRI-safe, it should be kept away from magnetic fields.

• Does the TDR-4S come with multiple models or sizes?

  The provided data does not specify multiple models or sizes for the TDR-4S. It is a singular device designed for monaural use, meaning it is intended for one ear only. If customization or additional configurations are required, they would need to be confirmed directly with Telex Communications, Inc.

• What regulatory clearance does the TDR-4S hold, and how does it apply to clinical use?

  The TDR-4S holds FDA 510(k) clearance under the reference number K915384, classified as a Class II medical device under product code EPF. This clearance confirms that the device meets FDA standards for safety and effectiveness as a hearing aid and wireless FM receiver for ENT applications. Clinicians may rely on this clearance when integrating the device into treatment plans for patients with unilateral hearing loss.