510(k) K912154

QUALITONE MODEL 48 C-WR-BEHIND THE EAR by Qualitone — Product Code ESD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 17, 1991
Date Received: May 15, 1991
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 Qualitone

K961827 — IN-THE-EAR (July 3, 1996)
K955466 — DYNAMEQ-II OPTION (February 13, 1996)
K955359 — CYBER III OPTION UM, UC312, UC10, UCIC (December 19, 1995)
K953884 — PROPHET (October 27, 1995)
K941107 — THE CANAL (C.I.C.) AKA/HIDDEN EAR (August 9, 1994)
K935348 — ODYSSEY CLINICAL AUDIOMETER (February 9, 1994)
K935289 — PRO FIT-CYBER II OPTION (December 22, 1993)
K923006 — AS-90 (September 18, 1993)
K923007 — AT-2 (February 26, 1993)
K923986 — CYBERNETIC OPTION (CYBER I) (September 10, 1992)

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