Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Miracle-Ear, Inc. — Predicate Candidate Screening
65 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
42 daysmedian FDA review time
92 days90th percentile
65clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972344 | MIRACLE-EAR DIGITAL BTE | Miracle-Ear, Inc. | 1997-07-23 | 29 | 0 |
| K972346 | MIRACLE-EAR ITE DIGITAL | Miracle-Ear, Inc. | 1997-07-23 | 29 | 0 |
| K972345 | DAHLBERG/MIRACLE-EAR | Miracle-Ear, Inc. | 1997-07-23 | 29 | 0 |
| K970262 | MULTI-CHANNEL COMPRESSION BTE (SD) | Miracle-Ear, Inc. | 1997-03-31 | 67 | 0 |
| K964419 | MIRACLE - EAR (ITE/ITC/CIC) | Miracle-Ear, Inc. | 1997-02-04 | 126 | 0 |
| K965063 | AUDIOTONE (A-552) | Miracle-Ear, Inc. | 1997-01-27 | 40 | 0 |
| K965057 | AUDIOTONE (A554H) | Miracle-Ear, Inc. | 1997-01-27 | 40 | 0 |
| K965049 | DAHLBERG (A-554) | Miracle-Ear, Inc. | 1997-01-27 | 40 | 0 |
| K964669 | MIRACLE-EAR OR AUDIOTONE | Miracle-Ear, Inc. | 1996-12-26 | 35 | 0 |
| K964794 | DAHLBERG K-AMP BTE | Miracle-Ear, Inc. | 1996-12-23 | 24 | 0 |
| K964530 | DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT | Miracle-Ear, Inc. | 1996-11-27 | 15 | 0 |
| K960804 | MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC | Miracle-Ear, Inc. | 1996-04-05 | 37 | 0 |
| K954119 | MIRACLE EAR MIRAGE | Miracle-Ear, Inc. | 1996-01-24 | 145 | 0 |
| K954941 | MIRACLE EAR AND AUDIOTONE | Miracle-Ear, Inc. | 1995-12-22 | 53 | 0 |
| K954528 | MIRACLE - EAR MODEL PBP | Miracle-Ear, Inc. | 1995-10-07 | 8 | 0 |
| K950691 | MIRACLE-EAR MODEL PBM PROGRAMMABLE HEARING AID | Miracle-Ear, Inc. | 1995-03-31 | 45 | 0 |
| K950692 | MIRACLE-EAR MODEL PBS PROGRAMMABLE HEARING AID | Miracle-Ear, Inc. | 1995-03-31 | 45 | 0 |
| K950693 | MIRACLE-EAR MODEL PM1/PM2 PROGRAMMABLE HEARING AID | Miracle-Ear, Inc. | 1995-03-31 | 45 | 0 |
| K943960 | UV CURED METHYL METHACRYLATE HEARING AID SHELL MATERIALS | Miracle-Ear, Inc. | 1994-10-20 | 66 | 0 |
| K943826 | MIRACLE-EAR MIRAGE | Miracle-Ear, Inc. | 1994-09-23 | 49 | 0 |
| K942523 | MIRACLE-EAR IMPRESSION MATERIAL KIT | Miracle-Ear, Inc. | 1994-09-23 | 161 | 0 |
| K943825 | MIRACLE EAR CONFIDANTE | Miracle-Ear, Inc. | 1994-09-21 | 47 | 0 |
| K941295 | SHARP II HELIX HEARING AID | Miracle-Ear, Inc. | 1994-06-17 | 92 | 0 |
| K941039 | WAX GUARD OPTION | Miracle-Ear, Inc. | 1994-05-12 | 70 | 0 |
| K941121 | AUDIOTONE MODEL A-54 | Miracle-Ear, Inc. | 1994-05-12 | 64 | 0 |
| K941293 | SHARP II SEMI CONTOUR HEARING AID | Miracle-Ear, Inc. | 1994-05-12 | 56 | 0 |
| K941294 | SHARP II LOW PROFILE HEARING AID | Miracle-Ear, Inc. | 1994-05-12 | 56 | 0 |
| K941122 | AUDIOTONE MODEL A-54SR | Miracle-Ear, Inc. | 1994-05-12 | 64 | 0 |
| K941292 | SHARP II FULL CONTOUR | Miracle-Ear, Inc. | 1994-05-12 | 56 | 0 |
| K935962 | MIRACLE-EAR WITH POWER CIRCUIT OPTION | Miracle-Ear, Inc. | 1994-05-04 | 142 | 0 |
| K940458 | MIRACLE-EAR CONFIDANTE | Miracle-Ear, Inc. | 1994-03-21 | 48 | 0 |
| K934940 | MIRACLE-EAR ENTRE | Miracle-Ear, Inc. | 1994-03-07 | 140 | 0 |
| K935265 | MIRACLE EAR MODEL SHARP II CANAL | Miracle-Ear, Inc. | 1993-12-15 | 43 | 0 |
| K935266 | MIRACLE EAR MODEL SHARP II MICRO CANAL HEARING AID | Miracle-Ear, Inc. | 1993-12-15 | 43 | 0 |
| K934597 | CLARIFIER II CIRCUIT OPTION | Miracle-Ear, Inc. | 1993-11-19 | 56 | 0 |
| K926091 | AUDIOTONE MODEL A-98 | Miracle-Ear, Inc. | 1993-02-12 | 72 | 0 |
| K926092 | MIRACLE-EAR MODEL HL | Miracle-Ear, Inc. | 1993-02-12 | 72 | 0 |
| K920093 | AUDIOTONE MODEL A-96 | Miracle-Ear, Inc. | 1992-01-30 | 22 | 0 |
| K920092 | AUDIOTONE MODEL A97 | Miracle-Ear, Inc. | 1992-01-28 | 20 | 0 |
| K914477 | AUDIOTONE MODEL A-95 BEHIND-THE-EAR HEARING AID | Miracle-Ear, Inc. | 1991-10-21 | 13 | 0 |
| K911096 | DAHLBERG MODEL LZ BTE HEARING AID | Miracle-Ear, Inc. | 1991-03-21 | 9 | 0 |
| K911064 | DAHLBERG MODEL LG BTE HEARING AID | Miracle-Ear, Inc. | 1991-03-21 | 10 | 0 |
| K911063 | DAHLBERG MODEL LU BTE HEARING AID | Miracle-Ear, Inc. | 1991-03-21 | 10 | 0 |
| K910979 | DAHLBERG MODEL LT BTE HEARING AID | Miracle-Ear, Inc. | 1991-03-21 | 14 | 0 |
| K910809 | DAHLBERG MODEL LB BEHIND-THE-EAR HEARING AID | Miracle-Ear, Inc. | 1991-03-21 | 23 | 0 |
| K901745 | AUDIOTONE MODEL A-52S BEHIND-THE-EAR HEARING INST. | Miracle-Ear, Inc. | 1990-05-29 | 42 | 0 |
| K901783 | AUDIOTONE ITE HEARING AID MODEL ZA (MICRO) | Miracle-Ear, Inc. | 1990-05-29 | 42 | 0 |
| K901747 | AUDIOTONE ITE HEARING AID MODEL ZG (MIRAGE) | Miracle-Ear, Inc. | 1990-05-29 | 42 | 0 |
| K901746 | AUDIOTONE ITE HEARING AID MODEL ZD (XT) | Miracle-Ear, Inc. | 1990-05-29 | 42 | 0 |
| K897035 | MIRACLE EAR MODEL PC PROG. IN-THE-EAR HEARING AID | Miracle-Ear, Inc. | 1990-05-23 | 156 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda