# K043090: Easylistener 2 FM, Radium FM and Vocalight Infrared Sound Field Systems

- Pathway: 510(k) (Traditional)
- Applicant: Phonic Ear, Inc.
- Decided: Dec 23, 2004 after 45 days
- Product code: LZI (Device, Assistive Listening)
- Device class: 2
- Regulation: 21 CFR 874.3320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K974287 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974287: FM Receiver - Auditory Trainer, Phonic Ear, Inc. (1998) Summary page 1.

## Most influential descendants
- K133352: Hypersound Audio System (HSS) (2014), 0 descendants of its own

## Indications for use
Sound Field wireless amplification systems are intended for use as group auditory trainers used to communicate simultaneously with one or more listeners with normal hearing or hearing impairments. The device is used with an associated transmitter microphone and speaker systems and does not provide coupling to the ear through either earphones or earmolds. These systems use FM and/or infrared wireless technology which include receivers, transmitters, and strategic placement of high quality speaker systems and can be used with or without BTE hearing aids and/or personal FM devices. The talker's voice is mildly amplified and dispersed throughout the room to assist listeners, regardless of seating location, to consistently hear what the talker is saying.

Source page: https://510kreport.com/device/K043090
Methodology: https://510kreport.com/methodology