510(k) · Cleared

Cleared

Easylistener 2 FM, Radium FM and Vocalight Infrared Sound Field Systems

K043090510(k) TraditionalCleared Dec 23, 200445-day reviewClass II21 CFR 874.3320

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Phonic Ear, Inc. · LZI Device, Assistive Listening

Cleared on Dec 23, 2004 as substantially equivalent to K974287 (Phonic Ear, Inc., 1998) after a 45-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.

Decided: Dec 23, 2004
Review: 45 days
Class: Class II
Product code: LZI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K974287 (1998). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK974287 FM Receiver - Auditory TrainerPhonic Ear, Inc. · 1998
This deviceK043090 Easylistener 2 FM, Radium FM and Vocalight Infrared Sound Field…Phonic Ear, Inc. · 2004
Descendant · cites it directly · 0 of its ownK133352 Hypersound Audio System (HSS)Hypersound Health, Inc. · 2014

Most influential descendants

Showing 1 of 1 · See all

K133352Hypersound Audio System (HSS)Hypersound Health, Inc. · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K974287	FM Receiver - Auditory Trainer	Phonic Ear, Inc.	1998	—
0 (this device)	K043090	Easylistener 2 FM, Radium FM and Vocalight Infrared Sound Field Systems	Phonic Ear, Inc.	2004	—
+1	K133352	Hypersound Audio System (HSS)	Hypersound Health, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K043090, 1998–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LZI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K974287	FM Receiver - Auditory Trainer Summary page 1 …various types of approved Group Hearing- Aids or Group Auditory Trainers that are directly connected or coupled to the listener as described above with similar results: K974287 - FM Receiver Group Auditory Trainer-Solaris Binaural Hearing System 5 of 30…	Phonic Ear, Inc.	1998	—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K133352	Hypersound Audio System (HSS)	Hypersound Health, Inc.	2014	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K133352 (Hypersound Health, Inc., 2014) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LZI devices

LZI Device, Assistive Listening: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZI

FDA has decided no LZI device since 2007.

Median 510(k) review, days · LZI

Too few LZI 510(k)s in any year since 2007 to give a median.

Recalls per year · LZI

No recall names LZI since 2007.

Adverse event reports per year · LZI

1in 2024

2007high 2 (2011) · low 0 (2007)2025

MAUDE reports naming product code LZI, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	2
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	1
2025	—	0
2026	—	—

What is it indicated for?

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…

Read the full statement (113 words)

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043090 · printed Nov 5, 2026

Cite this page

510(k) Report. “K043090: Easylistener 2 FM, Radium FM and Vocalight Infrared Sound Field Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043090

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026