510(k) · Cleared
ClearedFM Receiver - Auditory Trainer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phonic Ear, Inc. · EPF Hearing Aid, Group And Auditory Trainer
Cleared on Feb 10, 1998 after an 88-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Feb 10, 1998
- Review
- 88 days
- Class
- Class II
- Product code
- EPF
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK974287 FM Receiver - Auditory TrainerPhonic Ear, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK043090 Easylistener 2 FM, Radium FM and Vocalight Infrared Sound Field…Phonic Ear, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK133352 Hypersound Audio System (HSS)Hypersound Health, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974287 | FM Receiver - Auditory Trainer | Phonic Ear, Inc. | 1998 | — |
| +1 | K043090 | Easylistener 2 FM, Radium FM and Vocalight Infrared Sound Field Systems | Phonic Ear, Inc. | 2004 | — |
| +2 | K133352 | Hypersound Audio System (HSS) | Hypersound Health, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2014 | 1 | 0 |
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
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043090 | Easylistener 2 FM, Radium FM and Vocalight Infrared Sound Field Systems | 2004 | 1 |
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?
- Of its descendants, K043090 (Phonic Ear, Inc., 2004) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EPF devicesEPF Hearing Aid, Group And Auditory Trainer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EPF
1in 2014
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
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This device is a rcceiver for an FM group auditory trainer. [l 1s 1ntended to be used with the Phonic Ear PE 571t group auditory trainecr transmitter. Auditory trainers arc used primarily in institutions (schools. churches, theaters, etc.) to allow teachers, ministers, etc. Lo communicate with individuals with hearing deficits.
This device can also be used with its built-in microphones or plug-in microphones as a stand alone assistive listening device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974287 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974287: FM Receiver - Auditory Trainer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974287
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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