| UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE (K974340) | Unitron Industries, Inc. | 1997-12-12 |
| UNITRON MODEL SOUND F/XD PROGRAMMABLE (K974339) | Unitron Industries, Inc. | 1997-12-12 |
| UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) (K974338) | Unitron Industries, Inc. | 1997-12-12 |
| HI-69E, HI-69N, HI-69P (K974129) | Rockwin Corp. | 1997-12-12 |
| RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) (K974257) | Resound Corp. | 1997-12-12 |
| HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL (K973927) | Hyunjae Corp. | 1997-12-11 |
| ARTICULATE FITTING SYSTEM (K973320) | Decibel Instruments, Inc. | 1997-11-25 |
| DOW CORNING SILASTIC ELASTOMER Q7-4750 (K973166) | Technical Products, Inc. | 1997-11-21 |
| FLEXTIP GRASPER (K972450) | Endius, Inc. | 1997-11-21 |
| K-PISTON WITH BAND HOOK /ANGULAR PISTON (K973356) | Heinz Kurz | 1997-11-21 |
| FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48 (K973861) | Magnatone Hearing Aid Corp. | 1997-11-19 |
| DISPOSABLE SILICONE EPISTAXIS CATHETER (K973656) | Specialty Surgical Products, Inc. | 1997-11-18 |
| INTUBATION ENDOSCOPE AND INTRODUCER SHEATH (K970107) | Urohealth Systems, Inc. | 1997-11-18 |
| ULTRACELL PACKING WITH SLEEVE (K973085) | Ultracell Medical Technologies, Inc. | 1997-11-18 |
| SILICONE CARVING BLOCK (K973728) | Hanson Medical, Inc. | 1997-11-13 |
| INVOTEC EAR TAMPON (WICK) W/STRING (K973578) | Invotec International, Inc. | 1997-11-06 |
| POWERTREK INSTRUMENTS (K972057) | Medtrek Corp. | 1997-11-05 |
| PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER) (K973972) | Perfect Ear | 1997-11-04 |
| TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T) (K973226) | Heinz Kurz GmbH Medizintechnik | 1997-11-04 |
| MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER (K973665) | Magnatone Hearing Aid Corp. | 1997-11-04 |
| OTICON DIGISOUND COMPACT (K973886) | Oticon, Inc. | 1997-11-04 |
| OTICON DIGISOUND ITE (K973885) | Oticon, Inc. | 1997-11-04 |
| GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE (K971375) | Wilson Greatbatch Technologies, Inc. | 1997-10-31 |
| AMPLAID 171S (K972862) | Amplifon S.P.A. | 1997-10-31 |
| AIR CONDUCTION HEARING AID (K973846) | Baron Trading, Inc. | 1997-10-29 |
| DUALINE 100 BTE (K973948) | Bernafon-Maico, Inc. | 1997-10-28 |
| AM SERIES HEARING AID (K973579) | A & M Hearing, Ltd. | 1997-10-28 |
| URO MED NERVE STIMULATOR (K970971) | Uromed Corp. | 1997-10-27 |
| MODEL C-1 HEARING AID (K973043) | Better Hearing, Inc. | 1997-10-27 |
| D72 DIGITAL (K972818) | Philips Hearing Instruments Co. | 1997-10-17 |
| LORI/LORI, LORI-S (LORI STOCK AID) (K973376) | Lori Medical Laboratories, Inc. | 1997-10-14 |
| PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT (K972815) | Grace Medical, Inc. | 1997-10-08 |
| VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K (K972922) | Interview Medical Technology Corp. | 1997-10-08 |
| STRYKER HUMMER II MICRODEBRIDER SYSTEM (K972584) | Stryker Endoscopy | 1997-10-01 |
| PROMEX ENT TISSUE REMOVAL SYSTEM (K972865) | Promex, Inc. | 1997-09-29 |
| ENT IRRIGATING PUMP (70327700) (K973286) | Gyrus Ent LLC | 1997-09-29 |
| Z DEQ-II (K973266) | Electone, Inc. | 1997-09-23 |
| MONTGOMERY THYROPLASTY IMPLANT SYSTEM (K972317) | Boston Medical Products, Inc. | 1997-09-18 |
| K 15 AUDIOMETER (K972221) | American Electromedics Corp. | 1997-09-08 |
| DRY & STORE (K972776) | Ear Technology Corp. | 1997-09-08 |
| KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES (K972855) | KARL STORZ Endoscopy-America, Inc. | 1997-09-08 |
| TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) (K972735) | Mednet Locator, Inc. | 1997-09-05 |
| PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) (K972734) | Mednet Locator, Inc. | 1997-09-05 |
| PRISMA (K972998) | Siemens Hearing Instruments, Inc. | 1997-09-05 |
| XPS STRAIGHTSHOT MICRORESECTOR (K972453) | Xomed, Inc. | 1997-09-05 |
| CAUSSE PISTON (K972737) | Mednet Locator, Inc. | 1997-09-05 |
| OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE (K971166) | Richard Wolf Medical Instruments Corp. | 1997-08-27 |
| NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC) (K972039) | Nu-Sound | 1997-08-25 |
| CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1) (K963899) | Exmoor Plastics , Ltd. | 1997-08-22 |
| EARCHECK (K971859) | Mdi Instruments, Inc. | 1997-08-18 |
| HEARTLAND TECHNOLOGIES, ITE, ITC, CIC (K971845) | Sound Hearing Instruments, Inc. | 1997-08-15 |
| AIR CONDUCTION HAEARING AIDS (K971852) | Beltone Electronics Corp. | 1997-08-15 |
| LORIPRO, LORIPRO II (K972058) | Lori Medical Laboratories, Inc. | 1997-08-15 |
| PHONAK NOVO FORTE E3 (K972106) | Phonak, Inc. | 1997-08-15 |
| IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL (K971807) | Hear-Right, Inc. | 1997-08-07 |
| AMPLAID 460 (K971747) | Amplifon S.P.A. | 1997-08-05 |
| V-12 LONG LIFE 675 HEARING AID (K972755) | Vista Labs | 1997-08-05 |
| RHINOCELL NASAL PACKINGS (K972459) | Boston Medical Products, Inc. | 1997-08-04 |
| AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN (K972585) | Heinz Kurz GmbH Medizintechnik | 1997-08-04 |
| BELL PROSTHESIS (PARTIAL) (K972492) | Heinz Kurz | 1997-08-04 |
| PHONAK EPICA (K972105) | Phonak, Inc. | 1997-08-01 |
| AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC (K972550) | Trutone | 1997-07-31 |
| PHONAK MICROZOOM P 2 (K972097) | Phonak, Inc. | 1997-07-30 |
| AUDIFON H20 PC/AUDIFON H32 PP (K972552) | Trutone | 1997-07-30 |
| OVATION HDP (K972373) | Orsonique, Inc. | 1997-07-29 |
| MYRINGOTOMY TUBE (K972126) | Mednet Locator, Inc. | 1997-07-29 |
| MYRINGOTOMY TUBE - BOBBIN WITH TAB (K972400) | Mednet Locator, Inc. | 1997-07-23 |
| MIRACLE-EAR DIGITAL BTE (K972344) | Miracle-Ear, Inc. | 1997-07-23 |
| BETTER HEARING, INC. MODEL L-1 HEARING AID (K971298) | Better Hearing, Inc. | 1997-07-23 |
| MIRACLE-EAR ITE DIGITAL (K972346) | Miracle-Ear, Inc. | 1997-07-23 |
| JAZZ PP AGC-O, JAZZ PP (K972542) | Trutone | 1997-07-23 |
| MYRINGOTOMY TUBE (K971943) | Mednet Locator, Inc. | 1997-07-23 |
| TWIST PPAGC-1, TWIST PP (K972543) | Trutone | 1997-07-23 |
| DAHLBERG/MIRACLE-EAR (K972345) | Miracle-Ear, Inc. | 1997-07-23 |
| MERIDIAN DSP (K972431) | Micro-Ear Technology, Inc. | 1997-07-23 |
| BIVALVE NASAL SPLINT (K972096) | Boston Medical Products, Inc. | 1997-07-15 |
| POST-STOP EPISTAXIS CATHETER (K972078) | Boston Medical Products, Inc. | 1997-07-10 |
| NASAL AIRWAY SPLINT (K972092) | Boston Medical Products, Inc. | 1997-07-08 |
| DOYLE COMBO NASAL AIRWAY SPLINT (K972151) | Boston Medical Products, Inc. | 1997-07-07 |
| CUSTOM NASAL SPLINT (K972082) | Boston Medical Products, Inc. | 1997-07-03 |
| ARGOSY DYNAMEQ (K971699) | Argosy Electronics | 1997-07-03 |
| RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (K971605) | Resound Corp. | 1997-07-03 |
| MEDIVISION SINOSCOPE (K971995) | Medivision Scope Service Center, Inc. | 1997-06-26 |
| EPI-MAX EPISTAXIS CATHETER (K972076) | Boston Medical Products, Inc. | 1997-06-26 |
| EPI-STOP EPISTAXIS CATHETER (K972077) | Boston Medical Products, Inc. | 1997-06-26 |
| TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05 (K971296) | National Hearing Aid Dist., Inc. | 1997-06-20 |
| DANAVOX MODELS 163/162 BTE (K971032) | Gn Danavox, Inc. | 1997-06-17 |
| AUDALLION III HEARING SYSTEM (K971031) | Gn Danavox, Inc. | 1997-06-17 |
| DUALINE 400 CIC (K971158) | Bernafon-Maico, Inc. | 1997-06-13 |
| AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC (K971399) | General Hearing Instruments, Inc. | 1997-06-13 |
| PHILIPS S1694, S1695 (K971804) | Philips Hearing Instruments Co. | 1997-06-06 |
| WIDEX SENSO DIGITAL (MINI CANAL) (K971535) | Widex Hearing Aid Co., Inc. | 1997-06-06 |
| GSI SA60 DPOAE SYSTEM (K970324) | Grason-Stadler, Inc. | 1997-06-06 |
| RIONET HB-79P (K971693) | Authorized Hearing Systems, Inc. | 1997-06-06 |
| VISTA V-38 CIC (K970939) | Vista Labs | 1997-06-06 |
| POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN (K970880) | Micro-Ear Technology, Inc. | 1997-06-06 |
| PROVOX 2 VOICE PROSTHESIS SYSTEM (K971244) | Atos Medical AB | 1997-06-06 |
| SCIENTIFIC PLASTICS MODEL SP (K971299) | Scientific Plastics, Inc. | 1997-06-06 |
| NEURO PULSE II,III (K971143) | Aaron Medical Industries | 1997-06-06 |
| MAICO MA52 (K971080) | Bernafon-Maico, Inc. | 1997-06-06 |