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510(k) K897154

NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE by Nicolet Instrument Corp. — Product Code ESD

K897154 is an FDA 510(k) premarket notification submitted by Nicolet Instrument Corp. for the device "NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE". The FDA issued a decision of Substantially Equivalent on April 30, 1990. The device falls under product code ESD (Hearing Aid, Air-Conduction, Prescription), a Class I device regulated under 21 CFR 874.3300. Nicolet Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1990
Date Received
December 26, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hearing Aid, Air-Conduction, Prescription
Device Class
Class I
Regulation Number
874.3300
Review Panel
EN
Submission Type

An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is a prescription hearing aid.

Other clearances by Nicolet Instrument Corp.

  • K921138 — NICOLET ULTRASOM ACQUISITION STATION (May 14, 1993)
  • K923315 — NICOLET ARK SYSTEM (November 23, 1992)
  • K921927 — NICOLET VOYAGEUR (November 5, 1992)
  • K915652 — NICOLET PORATBLE SPIRIT SYSTEM (February 7, 1992)
  • K905632 — NICOLET MAPLELEAF SYSTEM (June 7, 1991)
  • K894629 — NICOLET BEAM II SYSTEM (March 9, 1990)
  • K896477 — NICOLET REAL EAR ANALYZER (February 8, 1990)
  • K883781 — NICOLET NEUROPORT/ACE SYSTEM (June 5, 1989)
  • K890495 — NICOLET VIKING II SYSTEM (March 16, 1989)
  • K884294 — NICOLET NYSTAR PLUS SYSTEM (November 23, 1988)

Other clearances for product code ESD

  • K232999 — Lyric4 Hearing Aid (April 11, 2024)
  • K130790 — LYRIC2 (June 27, 2013)
  • K081136 — LYRIC HEARING AID (May 8, 2008)
  • K021867 — INSOUND XT SERIES HEARING AID (November 19, 2002)
  • K003558 — TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) (April 24, 2001)
  • K984518 — SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL (March 12, 1999)
  • K974751 — TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC (March 6, 1998)
  • K974242 — ARGOSY PROGRAMMABLE ONQUE (January 20, 1998)
  • K973880 — SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM (January 12, 1998)
  • K974211 — OPUS 2 - FULL CONCHA SERIES - ITE (December 15, 1997)

FDA data resources