510(k) Report

510(k) · Cleared

Cleared

Hypersound Audio System (HSS)

K133352510(k) TraditionalCleared Feb 12, 2014104-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

Hypersound Health, Inc. · EPF Hearing Aid, Group And Auditory Trainer

Cleared on Feb 12, 2014 as substantially equivalent to K043090 (Phonic Ear, Inc., 2004) after a 104-day review. Its family tree reaches back 2 generations to 1998.

Decided
Feb 12, 2014
Review
104 days
Class
Class II
Product code
EPF
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K974287 (1998). No later device cites it as a predicate yet.

K974287 · FM Receiver - Auditory Trainer · Phonic Ear, Inc. · 1998K043090 · Easylistener 2 FM, Radium FM and Vocalight Infrared Sound Field Systems · Phonic Ear, Inc. · 200419952000200520102015
K043090 · Easylistener 2 FM, Radium FM and Vocalight Infrared Sound Field Systems · Phonic Ear, Inc. · 2004K974287 · FM Receiver - Auditory Trainer · Phonic Ear, Inc. · 19980
  1. Root · 2 generations backK974287 FM Receiver - Auditory TrainerPhonic Ear, Inc. · 1998
  2. 1 generation backK043090 Easylistener 2 FM, Radium FM and Vocalight Infrared Sound Field…Phonic Ear, Inc. · 2004
  3. This deviceK133352 Hypersound Audio System (HSS)Hypersound Health, Inc. · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K974287FM Receiver - Auditory TrainerPhonic Ear, Inc.1998—
−1K043090Easylistener 2 FM, Radium FM and Vocalight Infrared Sound Field SystemsPhonic Ear, Inc.2004—
0 (this device)K133352Hypersound Audio System (HSS)Hypersound Health, Inc.2014—
FIG. 1 — Lineage of K133352, 1998–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 EPF? 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.

TypeNumberDeviceApplicantDecidedRecalls
*K043090Easylistener 2 FM, Radium FM and Vocalight Infrared Sound Field Systems
Summary page 1
…Class 11 K Number: K133352 FDA Establishment Registration #: 348096 4. Predicate Device - (1) Phonic Ear, Inc. K043090, SE: 12/23/2004 5. Device Description - The HyperSound Audio System (HSS) utilizes a specially designed emitter (speaker) that d…
Phonic Ear, Inc.2004—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 9.1 years on median.
  • None of the 2 ancestors has a recall.

How does its category compare?

All EPF devices

EPF Hearing Aid, Group And Auditory Trainer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · EPF

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EPF

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

Recalls per year · EPF

No recall names EPF since 2007.

Adverse event reports per year · EPF

No MAUDE report names EPF since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20141—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The HyperSound Group Auditory Trainer is indicated for use as a group auditory trainer or group hearing aid used to communicate simultaneously with one or more listeners with or without hearing loss and with or without the use of hearing aids in order to improve clarity and comprehension of sounds generated from sources such as a microphone, CD/DVD player, TV, Stereo System or other sound generation systems.

Indications for use as stated in the FDA summary.

Recent decisions in EPF

The EPF category page

  • K982683Telex Select 1-40 with Adaptive CompressionTelex Communications, Inc. · 1998
  • K974658Infrared Group Amplification System, Infrared Emitter, Infrared Body Worn Receiver, Infrared Headset…Phonic Ear, Inc. · 1998
  • K974287FM Receiver - Auditory TrainerPhonic Ear, Inc. · 1998
  • K970687Williams Sound, Personal FM, Hearing HelperWilliams Sound, LLC · 1997
  • K970665Williams Sound, Personal FM, Hearing HelperWilliams Sound, LLC · 1997

https://510kreport.com/device/K133352 · printed Nov 4, 2026

Cite this page

510(k) Report. “K133352: Hypersound Audio System (HSS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133352

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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