Home / 510(k) Clearances / K943961

510(k) K943961

THE MODEL ACAPPELLA IN THE EAR HEARING AID by Telex Communications, Inc. — Product Code ESD

K943961 is an FDA 510(k) premarket notification submitted by Telex Communications, Inc. for the device "THE MODEL ACAPPELLA IN THE EAR HEARING AID". The FDA issued a decision of Substantially Equivalent on May 15, 1995. The device falls under product code ESD (Hearing Aid, Air-Conduction, Prescription), a Class I device regulated under 21 CFR 874.3300. Telex Communications, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1995
Date Received
August 15, 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 Telex Communications, Inc.

  • K984243 — TELEX TINNITUS-COMPANION (January 21, 1999)
  • K982683 — TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION (October 6, 1998)
  • K964639 — TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II (January 21, 1997)
  • K963915 — TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION (November 8, 1996)
  • K961143 — TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40 (May 7, 1996)
  • K954579 — TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION (December 8, 1995)
  • K935048 — ARTISAN PROGRAMMER & HEARING AID (February 9, 1994)
  • K935366 — BINAURAL HEARING AID (January 13, 1994)
  • K933579 — MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING AID (August 23, 1993)
  • K933095 — 351-AGCO BEHIND-THE-EAR HEARING AID (July 26, 1993)

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