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510(k) K951068

RESOUND ED4-M MINI-CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-M) by Resound Corp. — Product Code ESD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1995
Date Received
March 8, 1995
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 Resound Corp.

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  • K974081 — RESOUND STEALTH CIC (December 12, 1997)
  • K974257 — RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) (December 12, 1997)
  • K971605 — RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (July 3, 1997)
  • K970215 — AUDALLION II HEARING SYSTEM (March 31, 1997)
  • K964557 — RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (November 27, 1996)
  • K964115 — RESOUND CC4 PERSONAL HEARING SYSTEM (November 4, 1996)
  • K960680 — RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES, EDR-EV, (April 10, 1996)
  • K960684 — HEARING AID - AIR CONDUCTION (April 10, 1996)
  • K960052 — RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241 (March 12, 1996)

Other clearances for product code ESD

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  • 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)
  • K974069 — OPUS 2 - CANAL SERIES (ITC) (December 15, 1997)