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 8 of 14
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K901642 | WIDEX HEARING AID MODEL THE DISCOVERY | Widex Hearing Aid Co., Inc. | 1990-05-23 | Traditional | PDF ↗ |
| K900846 | MODEL 366 HEARING AID | Telex Communications, Inc. | 1990-05-23 | Traditional | PDF ↗ |
| K900675 | PHONAK ITE 8000, 7000, 6000 ITE HEARING AID | Phonak, Inc. | 1990-05-23 | Traditional | PDF ↗ |
| K900831 | BTE PICO SCD, PICO SC | Phonak, Inc. | 1990-05-23 | Traditional | PDF ↗ |
| K900830 | BTE SUPER-FRONT PPCL4, SUPER-FRONT PPC4 | Phonak, Inc. | 1990-05-23 | Traditional | PDF ↗ |
| K893575 | SIEMENS MODEL 283 ASP | Siemens Hearing Instruments, Inc. | 1990-05-21 | Traditional | PDF ↗ |
| K893573 | SIEMENS MODEL 284 PP-L | Siemens Hearing Instruments, Inc. | 1990-05-21 | Traditional | PDF ↗ |
| K893574 | SIEMENS MODEL 284 PP-AGC | Siemens Hearing Instruments, Inc. | 1990-05-21 | Traditional | PDF ↗ |
| K893576 | SIEMENS MODEL 284 PP | Siemens Hearing Instruments, Inc. | 1990-05-21 | Traditional | PDF ↗ |
| K896995 | DISCRETION, IN THE CANAL HEARING INSTRUMENT | Gn Danavox, Inc. | 1990-04-30 | Traditional | PDF ↗ |
| K897154 | NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE | Nicolet Instrument Corp. | 1990-04-30 | Traditional | PDF ↗ |
| K901351 | SEARS MODEL 9098 ITE HEARING AID | Miracle-Ear, Inc. | 1990-04-27 | Traditional | PDF ↗ |
| K901350 | SEARS MODEL 9094 ITE HEARING AID | Miracle-Ear, Inc. | 1990-04-27 | Traditional | PDF ↗ |
| K901556 | AUDIOTONE MODEL FFI ITE HEARING AID | Miracle-Ear, Inc. | 1990-04-18 | Traditional | PDF ↗ |
| K897024 | MODEL AUDINA ITE HEATING AID | Audina Hearing Instrument | 1990-04-18 | Traditional | PDF ↗ |
| K891556 | EXAM GLOVES (VINYL) MFG. GLORIOUS WEALTH CO. | Green Light Import Export Co., Inc. | 1990-04-18 | Traditional | PDF ↗ |
| K901569 | BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL | Unitron Industries, Inc. | 1990-04-18 | Traditional | PDF ↗ |
| K901389 | SEARS MODEL LC9092 IN-THE-EAR HEARING INSTRUMENT | Miracle-Ear, Inc. | 1990-04-16 | Traditional | PDF ↗ |
| K901387 | SEARS MODEL LI9097 IN-THE-EAR HEARING INSTRUMENT | Miracle-Ear, Inc. | 1990-04-16 | Traditional | PDF ↗ |
| K895843 | AHAC ITE MODEL ENTENDRE | Aroostook Hearing Aid | 1990-04-16 | Traditional | PDF ↗ |
| K901469 | SEARS MODEL LF9096 IN-THE-EAR HEARING INSTRUMENT | Miracle-Ear, Inc. | 1990-04-16 | Traditional | PDF ↗ |
| K901388 | SEARS MODEL LM9091 IN-THE-EAR HEARING INSTRUMENT | Miracle-Ear, Inc. | 1990-04-16 | Traditional | PDF ↗ |
| K901470 | SEARS MODEL JCS IN-THE-EAR HEARING INSTRUMENT | Miracle-Ear, Inc. | 1990-04-16 | Traditional | PDF ↗ |
| K901386 | SEARS MODEL LS9093 IN-THE-EAR HEARING INSTRUMENT | Miracle-Ear, Inc. | 1990-04-13 | Traditional | PDF ↗ |
| K900862 | DAHLBERG MODEL JM IN-THE-EAR HEARING INSTRUMENT | Miracle-Ear, Inc. | 1990-04-13 | Traditional | PDF ↗ |
| K901316 | WIDEX MODEL Q9, BTE W/QUATRO REMOTE CONTROL | Widex Hearing Aid Co., Inc. | 1990-04-10 | Traditional | PDF ↗ |
| K901317 | WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL | Widex Hearing Aid Co., Inc. | 1990-04-10 | Traditional | PDF ↗ |
| K900968 | HEARING AID (ALL-IN-THE-EAR) | Audiology of Tulsa, Inc. | 1990-04-10 | Traditional | PDF ↗ |
| K901292 | OTICON BTE HEARING AID (BEHIND-THE-EAR), MODEL E44 | Oticon Corp. | 1990-04-10 | Traditional | PDF ↗ |
| K900789 | HEARING AID (ALL-IN-THE-EAR) | Solar Aid Corp. | 1990-04-04 | Traditional | PDF ↗ |
| K900861 | DAHLBERG MODEL JH IN-THE-EAR HEARING INSTRUMENT | Miracle-Ear, Inc. | 1990-04-04 | Traditional | PDF ↗ |
| K900636 | REXTON PP 142, PP 142-L | Rexton, Inc. | 1990-03-27 | Traditional | PDF ↗ |
| K895981 | WIDEX HEARING AID MODELS ES9T AND ES9H | Widex Hearing Aid Co., Inc. | 1990-03-15 | Traditional | PDF ↗ |
| K895982 | WIDEX HEARING AID MODEL ES 10 ASP T | Widex Hearing Aid Co., Inc. | 1990-03-15 | Traditional | PDF ↗ |
| K893004 | HEARING AID (ALL-IN-THE-EAR) | Hearing Specialists of Nevada, Inc. | 1990-03-14 | Traditional | PDF ↗ |
| K900692 | DAHLBERG MODEL JMS IN-THE-EAR HEARING INSTRUMENT | Miracle-Ear, Inc. | 1990-03-14 | Traditional | PDF ↗ |
| K900050 | MIRACLE EAR MODEL CK IN-THE-EAR HEARING AID | Miracle-Ear, Inc. | 1990-03-14 | Traditional | PDF ↗ |
| K895368 | IN THE EAR HEARING AID | Hearing Crafters of America | 1990-03-05 | Traditional | PDF ↗ |
| K900237 | MIRACLE EAR MODEL SM IN-THE-EAR HEARING AID | Miracle-Ear, Inc. | 1990-02-22 | Traditional | PDF ↗ |
| K900238 | MIRACLE EAR MODEL SK IN-THE-EAR HEARING AID | Miracle-Ear, Inc. | 1990-02-22 | Traditional | PDF ↗ |
| K896463 | RESOUND CUSTOM IN-THE CANAL HEARING AID MODEL CA1 | Resound Corp. | 1990-02-08 | Traditional | PDF ↗ |
| K893887 | BESTONE MODEL ITE & CANAL | Bestone Hearing Instruments | 1990-01-23 | Traditional | PDF ↗ |
| K896159 | DAHLBERG MODEL LP BEHIND-THE-EAR HEARING AID | Dahlberg Electronics, Inc. | 1990-01-22 | Traditional | PDF ↗ |
| K896157 | DAHLBERG MODEL LH BEHIND-THE-EAR HEARING AID | Dahlberg Electronics, Inc. | 1990-01-22 | Traditional | PDF ↗ |
| K896158 | DAHLBERG MODEL LA BEHIND-THE-EAR HEARING AID | Dahlberg Electronics, Inc. | 1990-01-22 | Traditional | PDF ↗ |
| K896057 | MINI PRIMO PLUS ASP BEHIND-THE-EAR HEARING AID | Rexton, Inc. | 1990-01-16 | Traditional | PDF ↗ |
| K896056 | REXTON RX12D CUSTOM IN-THE-EAR HEARING AID | Rexton, Inc. | 1990-01-10 | Traditional | PDF ↗ |
| K895517 | AURAL-TECH ITE HEARING AID MODEL AT-1S, 1SA, 1SC | Aural Technologies, Inc. | 1990-01-04 | Traditional | PDF ↗ |
| K895590 | ITE HEARING AID MODEL PA | Best Aid, Inc. | 1990-01-04 | Traditional | PDF ↗ |
| K891914 | ITC PRESCRIPTION SERIES MODEL CA AND C | Us Hearing Centers, Inc. | 1990-01-04 | Traditional | PDF ↗ |
| K894176 | FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA | Precision Hearing Instruments | 1989-11-03 | Traditional | PDF ↗ |
| K895134 | 3M INSTANT FIT CUSTOM EARMOLD | 3M Company | 1989-10-24 | Traditional | PDF ↗ |
| K894428 | HEARING AID (IN-THE-EAR) | Hearing Aid Express | 1989-10-24 | Traditional | PDF ↗ |
| K895140 | CUSTOM IN-THE-CANAL (ITC) HEARING AID MODEL I54 | Oticon Corp. | 1989-10-11 | Traditional | PDF ↗ |
| K894414 | HEARING AID (IN-THE-CANAL) | Hearing Aid Express | 1989-09-27 | Traditional | PDF ↗ |
| K893722 | LORI-MODEL H, HALF CONCHA IN-THE-EAR INSTRUMENT | Lori Medical Laboratories, Inc. | 1989-09-08 | Traditional | PDF ↗ |
| K893721 | LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT | Lori Medical Laboratories, Inc. | 1989-09-08 | Traditional | PDF ↗ |
| K893723 | LORI-MODEL L, CANAL IN-THE-EAR INSTRUMENT | Lori Medical Laboratories, Inc. | 1989-09-08 | Traditional | PDF ↗ |
| K893528 | OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID | Oticon Corp. | 1989-08-15 | Traditional | PDF ↗ |
| K892898 | ASTRO BEHIND-THE-EAR HEARING AID | Rexton, Inc. | 1989-08-08 | Traditional | PDF ↗ |
| K893927 | RESOUND CUSTOM IN-THE CANAL HEARING AID PHS-3 | Resound Corp. | 1989-08-04 | Traditional | PDF ↗ |
| K893432 | PERSONAL AMPLIFIER RECHARGEABLE MODEL TRIUMPH II | Electone, Inc. | 1989-08-04 | Traditional | PDF ↗ |
| K892338 | BEHIND-THE-EAR HEARING AID MODEL 48 AGCI | Qualitone | 1989-08-03 | Traditional | PDF ↗ |
| K891916 | ITE PRESCRIPTION SERIES MODEL PP + F | Us Hearing Centers, Inc. | 1989-07-14 | Traditional | PDF ↗ |
| K891915 | ITE PRESCRIPTION SERIES MODEL LP | Us Hearing Centers, Inc. | 1989-07-14 | Traditional | PDF ↗ |
| K892803 | PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911 | United Hearing Systems, Inc. | 1989-06-22 | Traditional | PDF ↗ |
| K890271 | ALPHA MODEL I ITE HEARING AID | Alpha Instruments, Inc. | 1989-06-16 | Traditional | PDF ↗ |
| K893433 | PERSONAL AMPLIFIER MODEL ULTRA HELIX | Electone, Inc. | 1989-06-14 | Traditional | PDF ↗ |
| K892458 | TELSTAR MODEL F ITE HEARING AID | Telstar Electronics, Inc. | 1989-06-06 | Traditional | PDF ↗ |
| K892460 | TELSTAR MODEL PP ITE HEARING AID | Telstar Electronics, Inc. | 1989-06-06 | Traditional | PDF ↗ |
| K892459 | TELSTAR MODEL C ITE HEARING AID | Telstar Electronics, Inc. | 1989-06-06 | Traditional | PDF ↗ |
| K892457 | TELSTAR MODEL 1/3 ITE HEARING AID | Telstar Electronics, Inc. | 1989-06-06 | Traditional | PDF ↗ |
| K890525 | INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA | Magnatone Hearing Aid Corp. | 1989-05-19 | Traditional | PDF ↗ |
| K892333 | REXTON RX12PP, RX20PP & RX34PP IN-THE-EAR HEAR AID | Rexton, Inc. | 1989-05-19 | Traditional | PDF ↗ |
| K892336 | BEHIND-THE-EAR HEARING AID MODEL 48 PP PC | Qualitone | 1989-05-19 | Traditional | PDF ↗ |
| K890102 | ITC & ITE HEARING AID, HEAR CLEAR MODELS 1-4 | Hear Clear, Inc. | 1989-05-11 | Traditional | PDF ↗ |
| K891594 | CERUMEN FILTER | Gn Danavox, Inc. | 1989-05-10 | Traditional | PDF ↗ |
| K892337 | BEHIND-THE-EAR HEARING AID MODEL 46 PP PC | Qualitone | 1989-05-10 | Traditional | PDF ↗ |
| K891251 | BEHIND-THE-EAR HEARING AID MODEL 408 W-H | Siemens Hearing Instruments, Inc. | 1989-03-31 | Traditional | PDF ↗ |
| K891250 | BEHIND-THE-EAR HEARING AID MODEL 264 D-PP-PC | Siemens Hearing Instruments, Inc. | 1989-03-29 | Traditional | PDF ↗ |
| K891011 | RESOUND ITC HEARING ENHANCEMENT SYS HES2, W/REMOTE | Resound Corp. | 1989-03-29 | Traditional | PDF ↗ |
| K884997 | ITE HEARING AID PARKER/TECHNITONE, MODEL PA | Hearing Enhancement Center, Inc. | 1989-03-29 | Traditional | PDF ↗ |
| K891249 | BEHIND-THE-EAR HEARING AID MODEL 303 ASP | Siemens Hearing Instruments, Inc. | 1989-03-29 | Traditional | PDF ↗ |
| K891248 | BEHIND-THE-EAR HEARING AID MODEL 304 PP-AGC-I | Siemens Hearing Instruments, Inc. | 1989-03-29 | Traditional | PDF ↗ |
| K890703 | CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A | Oticon Corp. | 1989-03-17 | Traditional | PDF ↗ |
| K890704 | BTE HEARING AID OTICON MODEL: E42P | Oticon Corp. | 1989-03-09 | Traditional | PDF ↗ |
| K885128 | WIDEX BTE HEARING AID MODEL Q8 | Widex Hearing Aid Co., Inc. | 1989-03-01 | Traditional | PDF ↗ |
| K884871 | RESOUND HES, DIGITALLY PROGR., ITE HEARING AID | Resound Corp. | 1989-02-22 | Traditional | PDF ↗ |
| K884583 | BTE HEARING AID SIEMENS MODEL 284PP-ASP | Siemens Hearing Instruments, Inc. | 1989-01-18 | Traditional | PDF ↗ |
| K882633 | ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID | Ensoniq Corp. | 1989-01-13 | Traditional | PDF ↗ |
| K884288 | HEARING AID, UNITRON BTE MODEL UM60-AGC0 | Unitron Industries, Inc. | 1989-01-03 | Traditional | PDF ↗ |
| K884113 | HEARING AID WIDEX BTE | Widex Hearing Aid Co., Inc. | 1988-12-19 | Traditional | PDF ↗ |
| K883773 | H.A.C. MODEL-B (ALL IN THE CANAL) | Hearing Aid Crafters | 1988-11-14 | Traditional | PDF ↗ |
| K883772 | H.A.C. MODEL-A (ALL IN THE EAR) | Hearing Aid Crafters | 1988-11-14 | Traditional | PDF ↗ |
| K883961 | UNIMAX(TM) HEARING AID BTE MODELS:100S, 110C, PPS4 | Unimax Hearing Instruments | 1988-10-31 | Traditional | PDF ↗ |
| K882678 | ITE HEARING AID, SIEMENS MODEL 007, WITH TELOS | Siemens Hearing Instruments, Inc. | 1988-09-22 | Traditional | PDF ↗ |
| K882721 | ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR | Hear-O Inc. C/O L.P. Leale & Assoc. | 1988-09-15 | Traditional | PDF ↗ |
| K883513 | HEARING AID, UNITRON MODEL VISTA 1000 | Unitron Industries, Inc. | 1988-09-01 | Traditional | PDF ↗ |
| K882691 | MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX | Maico Hearing Instruments, Inc. | 1988-08-30 | Traditional | PDF ↗ |
| K882471 | ITE HEARING AID, EARTECH/CUSTOM AID MODEL CA | Ear Tech, Inc. | 1988-08-26 | Traditional | PDF ↗ |
Product code ESD · Class I · Ear, Nose, Throat. Data: openFDA.