Auditory Trainer PE150R FM Receiver

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

510(k) Number

K893431 ↗

FDA Product Code

EPF

Device Class

Class II

Regulation

21 CFR Part 874.3320

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Phonic Ear

  Class I

  FDA 510(k) K830098 Active Cleared 1 Feb 1983

• Post-Auricular Hearing Aid Model Pe 805 SCD2

  Class I

  FDA 510(k) K872474 Active Cleared 28 Jul 1987

• Phonic Ear, Model PE475R

  Class II

  FDA 510(k) K862773 Active Cleared 9 Oct 1986

• Phonic Ear-Pe 845-Ppc

  Class I

  FDA 510(k) K822779 Active Cleared 4 Oct 1982

• Pe 400IR, Pe 400T, Pe 400E

  Class II

  FDA 510(k) K923234 Active Cleared 29 Sep 1992

• Fm Receiver - Auditory Trainer

  Class II

  FDA 510(k) K974287 Active Cleared 10 Feb 1998

See all devices from Phonic Ear, Inc. →

• What is the primary purpose of the Auditory Trainer PE150R FM Receiver?

  The PE150R FM Receiver is designed to improve auditory communication for individuals with hearing impairments in group settings. It transmits sound wirelessly from an associated transmitter microphone, allowing clear reception via earphones or earmolds. This makes it ideal for clinical or educational environments where group discussions or lectures occur, ensuring better accessibility for those with hearing challenges.

• How is the PE150R FM Receiver supplied and intended for use?

  The PE150R FM Receiver is supplied as a reusable device, intended for use in clinical and educational settings, particularly within Ear, Nose, and Throat (ENT) specialties. It is not meant for single-use and requires proper cleaning and maintenance to ensure functionality and hygiene, as outlined by the manufacturer’s guidelines.

• Does the PE150R FM Receiver require sterilization?

  No, the PE150R FM Receiver does not require sterilization. However, it must be cleaned and maintained regularly to prevent contamination and ensure optimal performance. The manufacturer provides specific cleaning instructions to follow for proper upkeep.

• Can the PE150R FM Receiver be used with both monaural and binaural configurations?

  Yes, the PE150R FM Receiver supports both monaural (single-ear) and binaural (two-ear) configurations. This flexibility allows users to choose the setup that best meets their auditory needs, whether for one ear or both.

• What regulatory pathway was followed for the PE150R FM Receiver?

  The PE150R FM Receiver received FDA 510(k) clearance under the Traditional review pathway, classified as a Class II device under Special Controls. The clearance number is K893431, and it falls under product code EPF, aligning with the FDA’s definition of a hearing aid intended for group use.