510(k) Report

510(k) · Cleared

Cleared

Telex TDR-7AA Binaural Hear Aid/Wireless FM Rec

K913495510(k) TraditionalCleared Nov 1, 199187-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

Telex Communications, Inc. · EPF Hearing Aid, Group And Auditory Trainer

Cleared on Nov 1, 1991 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Nov 1, 1991
Review
87 days
Class
Class II
Product code
EPF
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1998: 1 descendant cleared1990200020102020
  1. This deviceK913495 Telex TDR-7AA Binaural Hear Aid/Wireless FM RecTelex Communications, Inc. · 1991
  2. Descendant · cites it directly · 1 of its ownK961143 Telex Select 2-40 with Adaptive Compression S2-40Telex Communications, Inc. · 1996
  3. Descendant · 2 generations on · 0 of its ownK982683 Telex Select 1-40 with Adaptive CompressionTelex Communications, Inc. · 1998

Most influential descendants

Showing 2 of 2 · See all
  • K961143Telex Select 2-40 with Adaptive Compression S2-40Telex Communications, Inc. · 1996 · cites it directly1descendant
  • K982683Telex Select 1-40 with Adaptive CompressionTelex Communications, Inc. · 1998 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K913495Telex TDR-7AA Binaural Hear Aid/Wireless FM RecTelex Communications, Inc.1991—
+1K961143Telex Select 2-40 with Adaptive Compression S2-40Telex Communications, Inc.1996—
+2K982683Telex Select 1-40 with Adaptive CompressionTelex Communications, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
FIG. 1 — Lineage of K913495, 1991–1998Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K961143Telex Select 2-40 with Adaptive Compression S2-40Telex Communications, Inc.19961

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, K961143 (Telex Communications, Inc., 1996) has gone furthest, with 1 descendant of its own.

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.

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—

More from Telex Communications, Inc.

50 FDA decisions under this applicant name. See the company

  • K984243Telex Tinnitus-CompanionTelex Communications, Inc. · 1999
  • K982683Telex Select 1-40 with Adaptive CompressionTelex Communications, Inc. · 1998
  • K964639Telex in-the-Ear Custom Hearing Aid with Threshold Compression-IITelex Communications, Inc. · 1997
  • K963915Telex in-the-Ear Custom Hearing Aid with Threshold CompressionTelex Communications, Inc. · 1996
  • K961143Telex Select 2-40 with Adaptive Compression S2-40Telex Communications, Inc. · 1996

Recent decisions in EPF

The EPF category page

  • K133352Hypersound Audio System (HSS)Hypersound Health, Inc. · 2014
  • 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
  • K970665Williams Sound, Personal FM, Hearing HelperWilliams Sound, LLC · 1997

https://510kreport.com/device/K913495 · printed Nov 4, 2026

Cite this page

510(k) Report. “K913495: Telex TDR-7AA Binaural Hear Aid/Wireless FM Rec.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K913495

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026