510(k) · Cleared
ClearedTelex Select 1-40 with Adaptive Compression
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Telex Communications, Inc. · EPF Hearing Aid, Group And Auditory Trainer
Cleared on Oct 6, 1998 as substantially equivalent to K961143 (Telex Communications, Inc., 1996) after a 67-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Oct 6, 1998
- Review
- 67 days
- Class
- Class II
- Product code
- EPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K913495 (1991). No later device cites it as a predicate yet.
- Root · 2 generations backK913495 Telex TDR-7AA Binaural Hear Aid/Wireless FM RecTelex Communications, Inc. · 1991
- 1 generation backK961143 Telex Select 2-40 with Adaptive Compression S2-40Telex Communications, Inc. · 1996
- This deviceK982683 Telex Select 1-40 with Adaptive CompressionTelex Communications, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913495 | Telex TDR-7AA Binaural Hear Aid/Wireless FM Rec | Telex Communications, Inc. | 1991 | — |
| −1 | K961143 | Telex Select 2-40 with Adaptive Compression S2-40 | Telex Communications, Inc. | 1996 | — |
| 0 (this device) | K982683 | Telex Select 1-40 with Adaptive Compression | Telex Communications, Inc. | 1998 | — |
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? (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 | Decided |
|---|---|---|---|
| * | K961143 | Telex Select 2-40 with Adaptive Compression S2-40Summary page 1…Name: FM at-the-ear -Auditory Trainer Telohione 612-384-4061 Classification Name: Hearing Aid, Group and Auditory Trainer, 77EPF Equivalent to: Telex Model Select 2-40 K961143 Fox 8128540083 Description: Intended use: to amplify and transmit sound to the ear. Features: Adaptive Compression; True FM Ov… | 1996 |
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 7 years and passes through 1 company; a new generation was cleared every 4.5 years on median.
- None of the 2 ancestors has a 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?
The indication for use of the air conduction hearing aids is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following categories: slight, mild, moderate, and severe; high frequency, gradually sloping, reverse slope, and flat.
The Telex Select 1-40 BTE FM System is best suited for students of middle school age and older who have a moderate to profound hearing loss. It may be appealing to older students that have rejected FM amplification because of the stigma associated with body-worn auditory trainers.
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/K982683 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982683: Telex Select 1-40 with Adaptive Compression.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982683
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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