FDA Product Code
FDA Product Code ESD — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3300
510(k) Clearances — 1,367 records · page 2 of 14
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K964557 | RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION | Resound Corp. | 1996-11-27 | Traditional | PDF ↗ |
| K964502 | UNITRON MODEL SOUND F/XP +4 | Unitron Industries, Inc. | 1996-11-27 | Traditional | PDF ↗ |
| K963875 | AHS OMEGA K-AMP | Authorized Hearing Systems, Inc. | 1996-11-27 | Traditional | PDF ↗ |
| K964508 | UNITRON MODEL ICON AOHP +4 (ICON AOHP +4) | Unitron Industries, Inc. | 1996-11-27 | Traditional | PDF ↗ |
| K964503 | UNITRON MODEL SOUND F/X +4 | Unitron Industries, Inc. | 1996-11-27 | Traditional | PDF ↗ |
| K963788 | PRIMOFOCUS COMPACT | Oticon Corp. | 1996-11-27 | Traditional | PDF ↗ |
| K964530 | DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT | Miracle-Ear, Inc. | 1996-11-27 | Traditional | PDF ↗ |
| K964214 | STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS | Starkey Laboratories, Inc. | 1996-11-27 | Traditional | PDF ↗ |
| K964451 | PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC | Rexton, Inc. | 1996-11-27 | Traditional | PDF ↗ |
| K963745 | MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR) | Hearing Innovations, Inc. | 1996-11-26 | Traditional | PDF ↗ |
| K963874 | AHS OMEGA AGC | Authorized Hearing Systems, Inc. | 1996-11-26 | Traditional | PDF ↗ |
| K964180 | AUDIO 'D' SOUND SELECTOR POWER (SSP) | Hearing Solutions, Inc. | 1996-11-26 | Traditional | PDF ↗ |
| K963876 | AHS OMEGA PP | Authorized Hearing Systems, Inc. | 1996-11-26 | Traditional | PDF ↗ |
| K963879 | AHS DELTA 22 | Authorized Hearing Systems, Inc. | 1996-11-26 | Traditional | PDF ↗ |
| K963873 | AHS OMEGA DEQ | Authorized Hearing Systems, Inc. | 1996-11-26 | Traditional | PDF ↗ |
| K963881 | AHS DELTA 22 T | Authorized Hearing Systems, Inc. | 1996-11-26 | Traditional | PDF ↗ |
| K963915 | TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION | Telex Communications, Inc. | 1996-11-08 | Traditional | PDF ↗ |
| K964115 | RESOUND CC4 PERSONAL HEARING SYSTEM | Resound Corp. | 1996-11-04 | Traditional | PDF ↗ |
| K963818 | OVATION AGC-2 | Orsonique, Inc. | 1996-10-28 | Traditional | PDF ↗ |
| K963821 | OVATION AGC-1 | Orsonique, Inc. | 1996-10-28 | Traditional | PDF ↗ |
| K963822 | OVATION AGC-3 | Orsonique, Inc. | 1996-10-28 | Traditional | PDF ↗ |
| K963819 | OVATION ASP | Orsonique, Inc. | 1996-10-28 | Traditional | PDF ↗ |
| K963820 | OVATION LINEAR | Orsonique, Inc. | 1996-10-28 | Traditional | PDF ↗ |
| K963519 | EUROLINE A-675 SERIS | Starkey Laboratories, Inc. | 1996-09-27 | Traditional | PDF ↗ |
| K963604 | DYNAMIC EQ II - 2 CHANNEL WIDE DYNAMIC RANGE COMPRESSION | Midwest City Hearing Aid Center | 1996-09-27 | Traditional | PDF ↗ |
| K963607 | HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL | Midwest City Hearing Aid Center | 1996-09-20 | Traditional | PDF ↗ |
| K962388 | IN THE EAR HEARING AID | Unique Hearing Technology, Inc. | 1996-09-16 | Traditional | PDF ↗ |
| K963047 | AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY) | Fenwick Hearing Instruments | 1996-09-10 | Traditional | PDF ↗ |
| K962798 | AUDIO 'D' K-AMP HR FULL SHELL AND CANAL HEARING AIDS | Hearing Solutions, Inc. | 1996-09-09 | Traditional | PDF ↗ |
| K963122 | UNITRON MODEL ICON KR | Unitron Industries, Inc. | 1996-09-06 | Traditional | PDF ↗ |
| K963152 | RIONET HB-55AS | Authorized Hearing Systems, Inc. | 1996-09-05 | Traditional | PDF ↗ |
| K963154 | RIONET HB-54AS | Authorized Hearing Systems, Inc. | 1996-09-05 | Traditional | PDF ↗ |
| K963153 | RIONET HB-55S | Authorized Hearing Systems, Inc. | 1996-09-05 | Traditional | PDF ↗ |
| K962228 | MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT | Ototech Intl., Inc. | 1996-08-28 | Traditional | PDF ↗ |
| K962847 | MT10P, MT60-PP, MT60-AGC0, AND MT60 | Micro-Tech Hearing Instruments | 1996-08-09 | Traditional | PDF ↗ |
| K961770 | PHILIPS 71 SERIES | Philips Hearing Instruments Co. | 1996-08-02 | Traditional | PDF ↗ |
| K962170 | SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP | Siemens Hearing Instruments, Inc. | 1996-07-25 | Traditional | PDF ↗ |
| K961827 | IN-THE-EAR | Qualitone | 1996-07-03 | Traditional | PDF ↗ |
| K961907 | RIONET HEARING AID HB53-K | Authorized Hearing Systems, Inc. | 1996-07-03 | Traditional | PDF ↗ |
| K961729 | ARGOSY PROGRAMMABLE | Argosy Electronics | 1996-05-29 | Traditional | PDF ↗ |
| K961653 | PHONAK SONA P2 | Phonak, Inc. | 1996-05-29 | Traditional | PDF ↗ |
| K961622 | PHONAK PICONET2 P2 AZ | Phonak, Inc. | 1996-05-17 | Traditional | PDF ↗ |
| K961670 | CLARITY | Seig Technologies, Inc. | 1996-05-14 | Traditional | PDF ↗ |
| K961308 | AUDIO 'D' INTIMA CIC | Hearing Solutions, Inc. | 1996-05-07 | Traditional | PDF ↗ |
| K961082 | TECHNA TONE | Techna Tone | 1996-05-07 | Traditional | PDF ↗ |
| K961059 | DIGIFOCUS COMPACT | Oticon, Inc. | 1996-05-07 | Traditional | PDF ↗ |
| K960741 | COMFORTONE PHS | Comfortone America'S Value Hearing Aid Line | 1996-05-07 | Traditional | PDF ↗ |
| K961143 | TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40 | Telex Communications, Inc. | 1996-05-07 | Traditional | PDF ↗ |
| K961084 | AM 400 | Electone, Inc. | 1996-04-18 | Traditional | PDF ↗ |
| K960684 | HEARING AID - AIR CONDUCTION | Resound Corp. | 1996-04-10 | Traditional | PDF ↗ |
| K960680 | RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES, EDR-EV, & EDR-P1 | Resound Corp. | 1996-04-10 | Traditional | PDF ↗ |
| K960804 | MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC | Miracle-Ear, Inc. | 1996-04-05 | Traditional | PDF ↗ |
| K960410 | PERFECT EAR PE/PE-AGC/PE-B/PE-PWR | Perfect Ear | 1996-04-04 | Traditional | PDF ↗ |
| K960935 | AUDIO 'D' 2N SERIES HEARING AIDS(FULL SHELL ITE,HALF SHELL ITE, MINI CANAL, CANAL) | Hearing Solutions, Inc. | 1996-04-03 | Traditional | PDF ↗ |
| K960295 | LONG LIFE RX-12 | Rexton, Inc. | 1996-03-22 | Traditional | PDF ↗ |
| K960052 | RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241 | Resound Corp. | 1996-03-12 | Traditional | PDF ↗ |
| K960031 | AUDIOFLEX 120 | Maico Hearing Instruments, Inc. | 1996-03-07 | Traditional | PDF ↗ |
| K960284 | OTICON /PRIMOFOCUS (PF) | Oticon, Inc. | 1996-03-07 | Traditional | PDF ↗ |
| K960155 | UNITRON MODEL SOUND F/XP | Unitron Industries, Inc. | 1996-03-07 | Traditional | PDF ↗ |
| K955930 | BELTONE COMPOSER 2000 BTE HP | Beltone Electronics Corp. | 1996-03-01 | Traditional | PDF ↗ |
| K960494 | EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS | Starkey Laboratories, Inc. | 1996-03-01 | Traditional | PDF ↗ |
| K955879 | WIDEX MODEL SENSO DIGITAL (C16) | Widex Hearing Aid Co., Inc. | 1996-02-27 | Traditional | PDF ↗ |
| K955702 | SONATA U-01 | Electone, Inc. | 1996-02-22 | Traditional | PDF ↗ |
| K955466 | DYNAMEQ-II OPTION | Qualitone | 1996-02-13 | Traditional | PDF ↗ |
| K955878 | WIDEX MODEL SENSO DIGITAL (C8) | Widex Hearing Aid Co., Inc. | 1996-02-12 | Traditional | PDF ↗ |
| K955692 | FINETONE FSC, | Finetone Hearing Instruments | 1996-02-02 | Traditional | PDF ↗ |
| K955867 | RESOUND PERSONAL HEARING SYSTEM BT247 | Resound Corp. | 1996-02-02 | Traditional | PDF ↗ |
| K955288 | HEARING AID IMPRESSION MATERIAL | Crown Delta Corp. | 1996-02-02 | Traditional | PDF ↗ |
| K954119 | MIRACLE EAR MIRAGE | Miracle-Ear, Inc. | 1996-01-24 | Traditional | PDF ↗ |
| K954922 | REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE INSTRUMENTS | Rexton, Inc. | 1996-01-17 | Traditional | PDF ↗ |
| K954941 | MIRACLE EAR AND AUDIOTONE | Miracle-Ear, Inc. | 1995-12-22 | Traditional | PDF ↗ |
| K955574 | RESOUND PERSONAL HEARING SYSTEM BTP W/DAI | Resound Corp. | 1995-12-22 | Traditional | PDF ↗ |
| K955359 | CYBER III OPTION UM, UC312, UC10, UCIC | Qualitone | 1995-12-19 | Traditional | PDF ↗ |
| K954579 | TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION | Telex Communications, Inc. | 1995-12-08 | Traditional | PDF ↗ |
| K954236 | FACEPLATE (HEARING AID KIT) | Truetone Hearing Systems, Inc. | 1995-12-06 | Traditional | PDF ↗ |
| K954936 | BELTONE ULTIMA 80 OTOSONIC POWER PAS | Beltone Electronics Corp. | 1995-12-06 | Traditional | PDF ↗ |
| K953603 | HEARING TODAY HEARING AID | Hearing Today Laboratory, Inc. | 1995-11-13 | Traditional | PDF ↗ |
| K954937 | COAST HEARING CHS (CUSTOM HEARING SYSTEM) | Coast Hearing Services | 1995-11-13 | Traditional | PDF ↗ |
| K954794 | OTICON | Oticon, Inc. | 1995-11-13 | Traditional | PDF ↗ |
| K954526 | WIDEX SENSO DIGITAL (PX) | Widex Hearing Aid Co., Inc. | 1995-10-18 | Traditional | PDF ↗ |
| K953932 | UNITRON MODEL SOUND F/XD | Unitron Industries, Inc. | 1995-10-07 | Traditional | PDF ↗ |
| K954516 | UNITRON MODEL SOUND F/X II | Unitron Industries, Inc. | 1995-10-07 | Traditional | PDF ↗ |
| K953727 | UNITRON MODEL IKON AOHPD | Unitron Industries, Inc. | 1995-10-07 | Traditional | PDF ↗ |
| K954528 | MIRACLE - EAR MODEL PBP | Miracle-Ear, Inc. | 1995-10-07 | Traditional | PDF ↗ |
| K954430 | UNITRON MODEL SOUND F/X | Unitron Industries, Inc. | 1995-10-06 | Traditional | PDF ↗ |
| K954067 | 3M MODEL 8295 | 3M Company | 1995-09-28 | Traditional | PDF ↗ |
| K954054 | MAICO PRODIGY CIC SERIES | Maico Hearing Instruments, Inc. | 1995-09-28 | Traditional | PDF ↗ |
| K953921 | PHONAK 9900 CIC | Phonak, Inc. | 1995-09-18 | Traditional | PDF ↗ |
| K954038 | K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT | Argosy Electronics | 1995-09-18 | Traditional | PDF ↗ |
| K953770 | REXTON MINI-PRIMO PLUS, PP142, D.C .H.I. FAMILY | Rexton, Inc. | 1995-09-18 | Traditional | PDF ↗ |
| K951002 | AMENDMENTS TO MULTIFOCUS | Oticon A/S | 1995-09-18 | Traditional | PDF ↗ |
| K953728 | RX12 LINEAR FULL SHELL AND IN THE CANAL | Midwest City Hearing Aid Center | 1995-09-12 | Traditional | PDF ↗ |
| K953960 | HEARING AID (ALL-IN-THE-EAR) | Audina Hearing Instrument | 1995-09-12 | Traditional | PDF ↗ |
| K953729 | K AMP FULL SHELL AND IN THE EAR | Midwest City Hearing Aid Center | 1995-09-12 | Traditional | PDF ↗ |
| K951712 | HEARING AID (ALL-IN-THE-EAR) | Omega Hearing Aid Center | 1995-09-12 | Traditional | PDF ↗ |
| K953646 | UNITRON MODEL IKON AOHPL | Unitron Industries, Inc. | 1995-08-28 | Traditional | PDF ↗ |
| K953631 | SNIP INPUT COMPRESSION CLASS A | Midwest City Hearing Aid Center | 1995-08-28 | Traditional | PDF ↗ |
| K953543 | 3M MODEL 8200P MULTIPRO BTE | 3M Company | 1995-08-23 | Traditional | PDF ↗ |
| K945439 | PHONAK PICONET 232X-AZ HEARING INSTRUMENT | Phonak, Inc. | 1995-08-23 | Traditional | PDF ↗ |
| K953047 | Z20 | Electone, Inc. | 1995-08-22 | Traditional | PDF ↗ |
Product code ESD · Class I · Ear, Nose, Throat. Data: openFDA.