510(k) · Cleared
ClearedWilliams Sound, Personal FM, Hearing Helper
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Williams Sound, LLC · EPF Hearing Aid, Group And Auditory Trainer
Cleared on May 2, 1997 after a 70-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 2, 1997
- Review
- 70 days
- Class
- Class II
- Product code
- EPF
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
To improve the signal to noise ratio for a listener ir a var ety of vrvironmen:s where background noise, poor acoustics, and distance from a desired sound <ot rze contribue to hezring difficulty.
Any hearing and speech condition that can be improved by maximizing the signal to noise ratio for the listener. This includes: Low gain amplification for Atention Deficit Disorders, Learning Disabilities, Central Auditory Processing Disorders, amplification for mild to moderate conductive and sensorineural hearing loss, and amplification moderate 1o severe conductive and sensorineural hearing loss when used in conjunction with a personal hearing aid.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970665 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970665: Williams Sound, Personal FM, Hearing Helper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970665
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026