Group Auditory Training System

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

510(k) Number

K922720 ↗

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 clinical or educational settings is the Group Auditory Training System intended for use in, and how does it function in those environments?

  The Group Auditory Training System is designed for use in clinical settings like audiology clinics or educational environments such as group therapy sessions. It facilitates communication between a speaker and multiple listeners with hearing impairments by amplifying and transmitting audio signals via a transmitter microphone. The sound is then delivered to listeners through earphones or earmolds, allowing for either monaural or binaural configurations to accommodate different hearing needs.

• Is the Group Auditory Training System intended for single-use or reusable applications, and what maintenance considerations should be taken into account?

  The Group Auditory Training System is supplied as a reusable device, meaning it is intended for repeated use across multiple sessions. Since no specific sterility or storage conditions are mentioned beyond standard device maintenance, users should follow general cleaning and upkeep guidelines to ensure proper functionality and hygiene, particularly if shared among different patients or listeners.

• What types of audio configurations does the Group Auditory Training System support, and how does this benefit users?

  The Group Auditory Training System supports both monaural (single-ear) and binaural (two-ear) configurations, allowing flexibility depending on the user’s hearing needs. This versatility ensures that listeners with varying degrees or types of hearing loss can benefit from the amplified audio delivery, improving clarity and comprehension in group settings.

• How was the Group Auditory Training System evaluated for regulatory approval, and what medical specialty is it associated with?

  The Group Auditory Training System underwent a traditional 510(k) review process, determined to be substantially equivalent to a predicate device. It was evaluated by the FDA’s Ear, Nose, and Throat (ENT) advisory committee and falls under the classification of a Hearing Aid, Group and Auditory Trainer (EPF). This regulatory route aligns with its intended use in audiology and related therapeutic settings.

• Are there any special considerations for storage or handling of the Group Auditory Training System beyond routine maintenance?

  The provided data does not specify unique storage conditions beyond standard device maintenance. Since the system is reusable, it should be stored in a clean, dry environment when not in use to prevent damage or contamination. Users should follow manufacturer guidelines for proper handling to ensure longevity and optimal performance.