510(k) Report

510(k) · Cleared

Cleared

Intrastar Pre-Wired Faceplate for in-the-Ear Hearing Aids

K961593510(k) TraditionalCleared Nov 7, 1996197-day reviewClass I21 CFR 874.3300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Segi Hearing Aid Co. · LRB Face Plate Hearing Aid

Cleared on Nov 7, 1996 as substantially equivalent to K884871 (Resound Corp., 1989) and 1 other predicate after a 197-day review. Its family tree reaches back 1 generation to 1989.

Decided
Nov 7, 1996
Review
197 days
Class
Class I
Product code
LRB
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K884871 (1989). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1990: 1 other ancestorK884871 · Resound Hes, Digitally Progr., Ite Hearing Aid · Resound Corp. · 19891986198819901992199419961998
Other ancestors, by generation 1 generation back: 1 other ancestor K884871 · Resound Hes, Digitally Progr., Ite Hearing Aid · Resound Corp. · 19890
  1. Root · 1 generation backK884871 Resound Hes, Digitally Progr., Ite Hearing AidResound Corp. · 1989
  2. This deviceK961593 Intrastar Pre-Wired Faceplate for in-the-Ear Hearing AidsSegi Hearing Aid Co. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K884871Resound Hes, Digitally Progr., Ite Hearing AidResound Corp.1989—
0 (this device)K961593Intrastar Pre-Wired Faceplate for in-the-Ear Hearing AidsSegi Hearing Aid Co.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
FIG. 1 — Lineage of K961593, 1989–1996Source: 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.

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  • 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? (2)

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
*K884871Resound Hes, Digitally Progr., Ite Hearing Aid
Summary page 1
…onventional devices installed in in-the-ear hearing aids currently available through commercial distribution, such as: 510(k) Number Trade/Proprietary Name Manufacturer K884871 Resound In-The-Ear Hearing Resound Corp. Enhancement System (Attachment 3) K902846 PRIZM Hearing System AudioScience, Inc. (Att…
Resound Corp.1989—
*K902846Prizm Hearing System
Summary page 1
…commercial distribution, such as: 510(k) Number Trade/Proprietary Name Manufacturer K884871 Resound In-The-Ear Hearing Resound Corp. Enhancement System (Attachment 3) K902846 PRIZM Hearing System AudioScience, Inc. (Attachment 4) Description: Descriptions of the device functions, scientific concepts, a…
Audioscience, Inc.1990—

Also cleared against K884871: 1 other device →

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?

  • None of the 2 ancestors has a recall.
  • 1 other device also cites its predicate K884871.

How does its category compare?

All LRB devices

LRB Face Plate Hearing Aid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LRB

FDA has decided no LRB device since 2007.

Median 510(k) review, days · LRB

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

Recalls per year · LRB

No recall names LRB since 2007.

Adverse event reports per year · LRB

No MAUDE report names LRB 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
20140—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 intended use of these models is to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for impaired hearing.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K884871

1 other device cites the same predicate.

  • K964603Articular Hearing AidsDecibel Instruments, Inc. · 1996

Recent decisions in LRB

The LRB category page

  • K974219Faceplate AssemblyFinetone Hearing Instruments · 1998
  • K942722Module ProgramElectone, Inc. · 1994
  • K942236Audina Prewires (Faceplate Hearing Aid Series)Audina Hearing Instrument · 1994
  • K935048Artisan Programmer & Hearing AidTelex Communications, Inc. · 1994
  • K933040Gold CD Module, IteElectone, Inc. · 1993

https://510kreport.com/device/K961593 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961593: Intrastar Pre-Wired Faceplate for in-the-Ear Hearing Aids.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961593

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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