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510(k) K963995

STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER by Starkey Laboratories, Inc. — Product Code KLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1996
Date Received
October 4, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Masker, Tinnitus
Device Class
Class II
Regulation Number
874.3400
Review Panel
EN
Submission Type

Other clearances by Starkey Laboratories, Inc.

  • K201370 — Multiflex Tinnitus Technology (June 19, 2020)
  • K122876 — MULTIFLEX TINNITUS TECHNOLOGY (October 31, 2012)
  • K030180 — CRESCENT TINNITUS RETAINING SOUND GENERATOR (September 17, 2003)
  • K970952 — PRECISE IMPRESSION KIT (May 2, 1997)
  • K964245 — PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS (February 4, 1997)
  • K964340 — PORTAREM-3000, PFS-6000 (January 10, 1997)
  • K964216 — STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER (December 6, 1996)
  • K964244 — STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING (November 27, 1996)
  • K964214 — STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING (November 27, 1996)
  • K963838 — STARKEY TM AIR CONDUCTION TINNITUS MASKER (November 26, 1996)

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  • K221168 — Tinnitogram Signal Generator (February 1, 2023)
  • K221125 — SilentCloud (January 4, 2023)
  • K201370 — Multiflex Tinnitus Technology (June 19, 2020)
  • K193303 — Tinnitus Sound Generator Module (February 20, 2020)
  • K180495 — Tinnitus Sound Generator Module (November 30, 2018)
  • K181586 — Tinnitus Sound Generator Module (July 13, 2018)
  • K171243 — audifon Tinnitus-Module (October 19, 2017)
  • K163094 — TinniLogic Mobile Tinnitus Management Device (May 17, 2017)