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510(k) K890525

INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA by Magnatone Hearing Aid Corp. — Product Code ESD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1989
Date Received
February 2, 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 Magnatone Hearing Aid Corp.

  • K973861 — FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58 (November 19, 1997)
  • K973665 — MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL (November 4, 1997)
  • K944241 — MAGNATONE MODEL M PREWIRED FACEPLATE HEARING AID (November 16, 1994)
  • K911183 — NHS 2044P BODY AID, HEARING AID (July 9, 1991)
  • K911182 — NNHS 2050 SERIES (2055W-2054PP) HEARING AIDS (May 9, 1991)
  • K911174 — NHS 2009SP HEARING AID (May 9, 1991)
  • K852656 — MODEL M HEARING AID (December 27, 1985)

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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)