Company ยท US
Miracle-Ear, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 1997. Name variants (Inc, Corp, punctuation) are merged.
65510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 23, 1997 | K972346 | MIRACLE-EAR ITE DIGITAL Miracle-Ear, Inc. | ESD |
| Jul 23, 1997 | K972345 | DAHLBERG/MIRACLE-EAR Miracle-Ear, Inc. | ESD |
| Jul 23, 1997 | K972344 | MIRACLE-EAR DIGITAL BTE Miracle-Ear, Inc. | ESD |
| Mar 31, 1997 | K970262 | MULTI-CHANNEL COMPRESSION BTE (SD) Miracle-Ear, Inc. | ESD |
| Feb 4, 1997 | K964419 | MIRACLE - EAR (ITE/ITC/CIC) Miracle-Ear, Inc. | ESD |
| Jan 27, 1997 | K965063 | AUDIOTONE (A-552) Miracle-Ear, Inc. | ESD |
| Jan 27, 1997 | K965057 | AUDIOTONE (A554H) Miracle-Ear, Inc. | ESD |
| Jan 27, 1997 | K965049 | DAHLBERG (A-554) Miracle-Ear, Inc. | ESD |
| Dec 26, 1996 | K964669 | MIRACLE-EAR OR AUDIOTONE Miracle-Ear, Inc. | ESD |
| Dec 23, 1996 | K964794 | DAHLBERG K-AMP BTE Miracle-Ear, Inc. | ESD |
| Nov 27, 1996 | K964530 | DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT Miracle-Ear, Inc. | ESD |
| Apr 5, 1996 | K960804 | MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC Miracle-Ear, Inc. | ESD |
| Jan 24, 1996 | K954119 | MIRACLE EAR MIRAGE Miracle-Ear, Inc. | ESD |
| Dec 22, 1995 | K954941 | MIRACLE EAR AND AUDIOTONE Miracle-Ear, Inc. | ESD |
| Oct 7, 1995 | K954528 | MIRACLE - EAR MODEL PBP Miracle-Ear, Inc. | ESD |
| Mar 31, 1995 | K950693 | MIRACLE-EAR MODEL PM1/PM2 PROGRAMMABLE HEARING AID Miracle-Ear, Inc. | ESD |
| Mar 31, 1995 | K950692 | MIRACLE-EAR MODEL PBS PROGRAMMABLE HEARING AID Miracle-Ear, Inc. | ESD |
| Mar 31, 1995 | K950691 | MIRACLE-EAR MODEL PBM PROGRAMMABLE HEARING AID Miracle-Ear, Inc. | ESD |
| Oct 20, 1994 | K943960 | UV CURED METHYL METHACRYLATE HEARING AID SHELL MATERIALS Miracle-Ear, Inc. | ESD |
| Sep 23, 1994 | K943826 | MIRACLE-EAR MIRAGE Miracle-Ear, Inc. | ESD |
| Sep 23, 1994 | K942523 | MIRACLE-EAR IMPRESSION MATERIAL KIT Miracle-Ear, Inc. | ESD |
| Sep 21, 1994 | K943825 | MIRACLE EAR CONFIDANTE Miracle-Ear, Inc. | ESD |
| Jun 17, 1994 | K941295 | SHARP II HELIX HEARING AID Miracle-Ear, Inc. | ESD |
| May 12, 1994 | K941294 | SHARP II LOW PROFILE HEARING AID Miracle-Ear, Inc. | ESD |
| May 12, 1994 | K941293 | SHARP II SEMI CONTOUR HEARING AID Miracle-Ear, Inc. | ESD |
| May 12, 1994 | K941292 | SHARP II FULL CONTOUR Miracle-Ear, Inc. | ESD |
| May 12, 1994 | K941122 | AUDIOTONE MODEL A-54SR Miracle-Ear, Inc. | ESD |
| May 12, 1994 | K941121 | AUDIOTONE MODEL A-54 Miracle-Ear, Inc. | ESD |
| May 12, 1994 | K941039 | WAX GUARD OPTION Miracle-Ear, Inc. | ESD |
| May 4, 1994 | K935962 | MIRACLE-EAR WITH POWER CIRCUIT OPTION Miracle-Ear, Inc. | ESD |
| Mar 21, 1994 | K940458 | MIRACLE-EAR CONFIDANTE Miracle-Ear, Inc. | ESD |
| Mar 7, 1994 | K934940 | MIRACLE-EAR ENTRE Miracle-Ear, Inc. | ESD |
| Dec 15, 1993 | K935266 | MIRACLE EAR MODEL SHARP II MICRO CANAL HEARING AID Miracle-Ear, Inc. | ESD |
| Dec 15, 1993 | K935265 | MIRACLE EAR MODEL SHARP II CANAL Miracle-Ear, Inc. | ESD |
| Nov 19, 1993 | K934597 | CLARIFIER II CIRCUIT OPTION Miracle-Ear, Inc. | ESD |
| Feb 12, 1993 | K926092 | MIRACLE-EAR MODEL HL Miracle-Ear, Inc. | ESD |
| Feb 12, 1993 | K926091 | AUDIOTONE MODEL A-98 Miracle-Ear, Inc. | ESD |
| Jan 30, 1992 | K920093 | AUDIOTONE MODEL A-96 Miracle-Ear, Inc. | ESD |
| Jan 28, 1992 | K920092 | AUDIOTONE MODEL A97 Miracle-Ear, Inc. | LYY |
| Oct 21, 1991 | K914477 | AUDIOTONE MODEL A-95 BEHIND-THE-EAR HEARING AID Miracle-Ear, Inc. | ESD |
| Mar 21, 1991 | K911096 | DAHLBERG MODEL LZ BTE HEARING AID Miracle-Ear, Inc. | ESD |
| Mar 21, 1991 | K911064 | DAHLBERG MODEL LG BTE HEARING AID Miracle-Ear, Inc. | ESD |
| Mar 21, 1991 | K911063 | DAHLBERG MODEL LU BTE HEARING AID Miracle-Ear, Inc. | ESD |
| Mar 21, 1991 | K910979 | DAHLBERG MODEL LT BTE HEARING AID Miracle-Ear, Inc. | ESD |
| Mar 21, 1991 | K910809 | DAHLBERG MODEL LB BEHIND-THE-EAR HEARING AID Miracle-Ear, Inc. | ESD |
| May 29, 1990 | K901783 | AUDIOTONE ITE HEARING AID MODEL ZA (MICRO) Miracle-Ear, Inc. | ESD |
| May 29, 1990 | K901747 | AUDIOTONE ITE HEARING AID MODEL ZG (MIRAGE) Miracle-Ear, Inc. | ESD |
| May 29, 1990 | K901746 | AUDIOTONE ITE HEARING AID MODEL ZD (XT) Miracle-Ear, Inc. | ESD |
| May 29, 1990 | K901745 | AUDIOTONE MODEL A-52S BEHIND-THE-EAR HEARING INST. Miracle-Ear, Inc. | ESD |
| May 23, 1990 | K897035 | MIRACLE EAR MODEL PC PROG. IN-THE-EAR HEARING AID Miracle-Ear, Inc. | ESD |
Newest 50 of 65.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||