Panels › Ear, Nose, Throat › Product code ESD · Class 1
Hearing Aid, Air-Conduction, Prescription
Regulation 874.3300
0510(k)s in 12 months (1,367 all time)
0recalls in 12 months (4 all time)
1recalls that name a 510(k)
Top companies in ESD
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 23, 1997 | K972344 | MIRACLE-EAR DIGITAL BTE Miracle-Ear, Inc. | ESD |
| Jul 23, 1997 | K971298 | BETTER HEARING, INC. MODEL L-1 HEARING AID Better Hearing, Inc. | ESD |
| Jul 3, 1997 | K971699 | ARGOSY DYNAMEQ Argosy Electronics | ESD |
| Jul 3, 1997 | K971605 | RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION Resound Corp. | ESD |
| Jun 20, 1997 | K971296 | TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05 National Hearing Aid Dist., Inc. | ESD |
| Jun 17, 1997 | K971032 | DANAVOX MODELS 163/162 BTE Gn Danavox, Inc. | ESD |
| Jun 17, 1997 | K971031 | AUDALLION III HEARING SYSTEM Gn Danavox, Inc. | ESD |
| Jun 13, 1997 | K971399 | AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC General Hearing Instruments, Inc. | ESD |
| Jun 13, 1997 | K971158 | DUALINE 400 CIC Bernafon-Maico, Inc. | ESD |
| Jun 6, 1997 | K971804 | PHILIPS S1694, S1695 Philips Hearing Instruments Co. | ESD |
| Jun 6, 1997 | K971693 | RIONET HB-79P Authorized Hearing Systems, Inc. | ESD |
| Jun 6, 1997 | K971535 | WIDEX SENSO DIGITAL (MINI CANAL) Widex Hearing Aid Co., Inc. | ESD |
| Jun 6, 1997 | K971299 | SCIENTIFIC PLASTICS MODEL SP Scientific Plastics, Inc. | ESD |
| Jun 6, 1997 | K970939 | VISTA V-38 CIC Vista Labs | ESD |
| Jun 6, 1997 | K970880 | POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN Micro-Ear Technology, Inc. | ESD |
| May 28, 1997 | K970828 | UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMER United Hearing Systems, Inc. | ESD |
| May 8, 1997 | K970692 | UNITRON MODEL SOUND F/X CIC Unitron Industries, Inc. | ESD |
| May 2, 1997 | K970952 | PRECISE IMPRESSION KIT Starkey Laboratories, Inc. | ESD |
| Apr 24, 1997 | K970519 | UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE) Unitron Industries, Inc. | ESD |
| Apr 21, 1997 | K964898 | IN THE EAR HEARING AID Keytone Hearing Laboratory | ESD |
| Mar 31, 1997 | K970262 | MULTI-CHANNEL COMPRESSION BTE (SD) Miracle-Ear, Inc. | ESD |
| Mar 31, 1997 | K970215 | AUDALLION II HEARING SYSTEM Resound Corp. | ESD |
| Mar 28, 1997 | K970537 | REXTON MODEL 48 AND 49PP Rexton, Inc. | ESD |
| Mar 26, 1997 | K970904 | WIDEX SENSO DIGITAL (CIC) Widex Hearing Aid Co., Inc. | ESD |
| Mar 12, 1997 | K965254 | WIDEX MODEL SENSO DIGITAL (C9) Widex Hearing Aid Co., Inc. | ESD |
| Mar 11, 1997 | K970430 | ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCI Midwest City Hearing Aid Center | ESD |
| Feb 26, 1997 | K970057 | AHS OMEGA SP Authorized Hearing Systems, Inc. | ESD |
| Feb 11, 1997 | K964657 | SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF Micro-Ear Technology, Inc. | ESD |
| Feb 4, 1997 | K964419 | MIRACLE - EAR (ITE/ITC/CIC) Miracle-Ear, Inc. | ESD |
| Feb 4, 1997 | K964245 | PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS Starkey Laboratories, 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 |
| Jan 24, 1997 | K965218 | SENSO DIGITAL (C18) Widex Hearing Aid Co., Inc. | ESD |
| Jan 24, 1997 | K965088 | M11 SERIES: M11, M11M Philips Hearing Instruments Co. | ESD |
| Jan 24, 1997 | K964680 | COMFORTAID HEARING AID Ethical Hearing Instruments | ESD |
| Jan 21, 1997 | K964639 | TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II Telex Communications, Inc. | ESD |
| Jan 17, 1997 | K964816 | AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR Audina Hearing Instrument | 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 |
| Dec 12, 1996 | K964683 | DIGIFOCUS ITE Oticon, Inc. | ESD |
| Dec 6, 1996 | K964603 | ARTICULAR HEARING AIDS Decibel Instruments, Inc. | ESD |
| Dec 6, 1996 | K963878 | AHS OMEGA HF Authorized Hearing Systems, Inc. | ESD |
| Dec 6, 1996 | K963877 | AHS OMEGA CONCEPT Authorized Hearing Systems, Inc. | ESD |
| Dec 5, 1996 | K963958 | IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT Beltone Electronics Corp. | ESD |
| Dec 4, 1996 | K964035 | PHONAK MICROLINK, PERSONAL FM RECEIVER Phonak, Inc. | ESD |
| Nov 27, 1996 | K964557 | RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION Resound Corp. | ESD |
| Nov 27, 1996 | K964530 | DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT Miracle-Ear, Inc. | ESD |
| Nov 27, 1996 | K964511 | UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4) Unitron Industries, Inc. | ESD |
| Nov 27, 1996 | K964510 | UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4) Unitron Industries, Inc. | ESD |
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