Miracle-Ear, Inc.

Medical device manufacturer in Golden Valley, MN.

65510(k) clearances
0PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K972346Miracle-Ear Ite DigitalESD · Traditional 07/23/1997SE
K972345Dahlberg/Miracle-EarESD · Traditional 07/23/1997SE
K972344Miracle-Ear Digital BteESD · Traditional 07/23/1997SE
K970262Multi-Channel Compression Bte (SD)ESD · Traditional 03/31/1997SE
K964419Miracle - Ear (Ite/Itc/Cic)ESD · Traditional 02/04/1997SE
K965063Audiotone (A-552)ESD · Traditional 01/27/1997SE
K965057Audiotone (A554H)ESD · Traditional 01/27/1997SE
K965049Dahlberg (A-554)ESD · Traditional 01/27/1997SE
K964669Miracle-Ear or AudiotoneESD · Traditional 12/26/1996SE
K964794Dahlberg K-Amp BteESD · Traditional 12/23/1996SE
K964530Dahlberg Hearing Aid with Multi-Channel Compression CircuitESD · Traditional 11/27/1996SE
K960804Miracle Ear & Audiotone Model Ite/Itc/CicESD · Traditional 04/05/1996SE
K954119Miracle Ear MirageESD · Traditional 01/24/1996SE
K954941Miracle Ear and AudiotoneESD · Traditional 12/22/1995SE
K954528Miracle - Ear Model PBPESD · Traditional 10/07/1995SE
K950693Miracle-Ear Model PM1/PM2 Programmable Hearing AidESD · Traditional 03/31/1995SE
K950692Miracle-Ear Model PBS Programmable Hearing AidESD · Traditional 03/31/1995SE
K950691Miracle-Ear Model PBM Programmable Hearing AidESD · Traditional 03/31/1995SE
K943960UV Cured Methyl Methacrylate Hearing Aid Shell MaterialsESD · Traditional 10/20/1994SE
K943826Miracle-Ear MirageESD · Traditional 09/23/1994SE
K942523Miracle-Ear Impression Material KitESD · Traditional 09/23/1994SE
K943825Miracle Ear ConfidanteESD · Traditional 09/21/1994SE
K941295Sharp II Helix Hearing AidESD · Traditional 06/17/1994SE
K941294Sharp II Low Profile Hearing AidESD · Traditional 05/12/1994SE
K941293Sharp II Semi Contour Hearing AidESD · Traditional 05/12/1994SE
K941292Sharp II Full ContourESD · Traditional 05/12/1994SE
K941122Audiotone Model A-54SRESD · Traditional 05/12/1994SE
K941121Audiotone Model A-54ESD · Traditional 05/12/1994SE
K941039Wax Guard OptionESD · Traditional 05/12/1994SE
K935962Miracle-Ear with Power Circuit OptionESD · Traditional 05/04/1994SE
K940458Miracle-Ear ConfidanteESD · Traditional 03/21/1994SE
K934940Miracle-Ear EntreESD · Traditional 03/07/1994SE
K935266Miracle Ear Model Sharp II Micro Canal Hearing AidESD · Traditional 12/15/1993SE
K935265Miracle Ear Model Sharp II CanalESD · Traditional 12/15/1993SE
K934597Clarifier II Circuit OptionESD · Traditional 11/19/1993SE
K926092Miracle-Ear Model HLESD · Traditional 02/12/1993SE
K926091Audiotone Model A-98ESD · Traditional 02/12/1993SE
K920093Audiotone Model A-96ESD · Traditional 01/30/1992SE
K920092Audiotone Model A97LYY · Traditional 01/28/1992SE
K914477Audiotone Model A-95 Behind-The-Ear Hearing AidESD · Traditional 10/21/1991SE
K911096Dahlberg Model LZ Bte Hearing AidESD · Traditional 03/21/1991SE
K911064Dahlberg Model LG Bte Hearing AidESD · Traditional 03/21/1991SE
K911063Dahlberg Model Lu Bte Hearing AidESD · Traditional 03/21/1991SE
K910979Dahlberg Model LT Bte Hearing AidESD · Traditional 03/21/1991SE
K910809Dahlberg Model LB Behind-The-Ear Hearing AidESD · Traditional 03/21/1991SE
K901783Audiotone Ite Hearing Aid Model Za (Micro)ESD · Traditional 05/29/1990SE
K901747Audiotone Ite Hearing Aid Model ZG (Mirage)ESD · Traditional 05/29/1990SE
K901746Audiotone Ite Hearing Aid Model ZD (XT)ESD · Traditional 05/29/1990SE
K901745Audiotone Model A-52S Behind-The-Ear Hearing Inst.ESD · Traditional 05/29/1990SE
K897035Miracle Ear Model PC Prog. In-The-Ear Hearing AidESD · Traditional 05/23/1990SE
K901351Sears Model 9098 Ite Hearing AidESD · Traditional 04/27/1990SE
K901350Sears Model 9094 Ite Hearing AidESD · Traditional 04/27/1990SE
K901556Audiotone Model Ffi Ite Hearing AidESD · Traditional 04/18/1990SE
K901470Sears Model JCS In-The-Ear Hearing InstrumentESD · Traditional 04/16/1990SE
K901469Sears Model LF9096 In-The-Ear Hearing InstrumentESD · Traditional 04/16/1990SE
K901389Sears Model LC9092 In-The-Ear Hearing InstrumentESD · Traditional 04/16/1990SE
K901388Sears Model LM9091 In-The-Ear Hearing InstrumentESD · Traditional 04/16/1990SE
K901387Sears Model LI9097 In-The-Ear Hearing InstrumentESD · Traditional 04/16/1990SE
K901386Sears Model LS9093 In-The-Ear Hearing InstrumentESD · Traditional 04/13/1990SE
K900862Dahlberg Model JM In-The-Ear Hearing InstrumentESD · Traditional 04/13/1990SE
K900861Dahlberg Model JH In-The-Ear Hearing InstrumentESD · Traditional 04/04/1990SE
K900692Dahlberg Model JMS In-The-Ear Hearing InstrumentESD · Traditional 03/14/1990SE
K900050Miracle Ear Model CK In-The-Ear Hearing AidESD · Traditional 03/14/1990SE
K900238Miracle Ear Model SK In-The-Ear Hearing AidESD · Traditional 02/22/1990SE
K900237Miracle Ear Model SM In-The-Ear Hearing AidESD · Traditional 02/22/1990SE