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510(k) K945439

PHONAK PICONET 232X-AZ HEARING INSTRUMENT by Phonak, Inc. — Product Code ESD

K945439 is an FDA 510(k) premarket notification submitted by Phonak, Inc. for the device "PHONAK PICONET 232X-AZ HEARING INSTRUMENT". The FDA issued a decision of Substantially Equivalent on August 23, 1995. The device falls under product code ESD (Hearing Aid, Air-Conduction, Prescription), a Class I device regulated under 21 CFR 874.3300. Phonak, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1995
Date Received
October 28, 1994
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 Phonak, Inc.

  • K130790 — LYRIC2 (June 27, 2013)
  • K123450 — PHONAK TINNITUS BALANCE (February 11, 2013)
  • K972106 — PHONAK NOVO FORTE E3 (August 15, 1997)
  • K972105 — PHONAK EPICA (August 1, 1997)
  • K972097 — PHONAK MICROZOOM P 2 (July 30, 1997)
  • K964035 — PHONAK MICROLINK, PERSONAL FM RECEIVER (December 4, 1996)
  • K961653 — PHONAK SONA P2 (May 29, 1996)
  • K961622 — PHONAK PICONET2 P2 AZ (May 17, 1996)
  • K953921 — PHONAK 9900 CIC (September 18, 1995)
  • K950758 — DYNA 231X (March 21, 1995)

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