Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- EPFHearing Aid, Group And Auditory Trainer2Product Code
- NEACement, Ear, Nose And Throat2Product Code
- ESDHearing Aid, Air Conduction1Product Code
- K130790LYRIC21Cleared 510(K)
- K081136LYRIC HEARING AID1Cleared 510(K)
- K021867INSOUND XT SERIES HEARING AID1Cleared 510(K)
- K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)1Cleared 510(K)
- K984518SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL1Cleared 510(K)
- K974751TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC1Cleared 510(K)
- K974242ARGOSY PROGRAMMABLE ONQUE1Cleared 510(K)
- K973880SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM1Cleared 510(K)
- K974211OPUS 2 - FULL CONCHA SERIES - ITE1Cleared 510(K)
- K974152OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)1Cleared 510(K)
- K974069OPUS 2 - CANAL SERIES (ITC)1Cleared 510(K)
- K974338UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)1Cleared 510(K)
- K974339UNITRON MODEL SOUND F/XD PROGRAMMABLE1Cleared 510(K)
- K974340UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE1Cleared 510(K)
- K974257RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)1Cleared 510(K)
- K974129HI-69E, HI-69N, HI-69P1Cleared 510(K)
- K974081RESOUND STEALTH CIC1Cleared 510(K)
- K973927HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL1Cleared 510(K)
- K973861FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,481Cleared 510(K)
- K973972PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER)1Cleared 510(K)
- K973886OTICON DIGISOUND COMPACT1Cleared 510(K)
- K973885OTICON DIGISOUND ITE1Cleared 510(K)
- K973665MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER1Cleared 510(K)
- K973846AIR CONDUCTION HEARING AID1Cleared 510(K)
- K973948DUALINE 100 BTE1Cleared 510(K)
- K973579AM SERIES HEARING AID1Cleared 510(K)
- K973043MODEL C-1 HEARING AID1Cleared 510(K)
- K972818D72 DIGITAL1Cleared 510(K)
- K973376LORI/LORI, LORI-S (LORI STOCK AID)1Cleared 510(K)
- K973266Z DEQ-II1Cleared 510(K)
- K972776DRY & STORE1Cleared 510(K)
- K972998PRISMA1Cleared 510(K)
- K972039NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC)1Cleared 510(K)
- K972106PHONAK NOVO FORTE E31Cleared 510(K)
- K972058LORIPRO, LORIPRO II1Cleared 510(K)
- K971852AIR CONDUCTION HAEARING AIDS1Cleared 510(K)
- K971845HEARTLAND TECHNOLOGIES, ITE, ITC, CIC1Cleared 510(K)
- K971807IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL1Cleared 510(K)
- K972755V-12 LONG LIFE 675 HEARING AID1Cleared 510(K)
- K972105PHONAK EPICA1Cleared 510(K)
- K972550AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC1Cleared 510(K)
- K972552AUDIFON H20 PC/AUDIFON H32 PP1Cleared 510(K)
- K972097PHONAK MICROZOOM P 21Cleared 510(K)
- K972373OVATION HDP1Cleared 510(K)
- K972543TWIST PPAGC-1, TWIST PP1Cleared 510(K)
- K972542JAZZ PP AGC-O, JAZZ PP1Cleared 510(K)
- K972431MERIDIAN DSP1Cleared 510(K)
- K972344MIRACLE-EAR DIGITAL BTE1Cleared 510(K)
- K972345DAHLBERG/MIRACLE-EAR1Cleared 510(K)
- K972346MIRACLE-EAR ITE DIGITAL1Cleared 510(K)
- K971298BETTER HEARING, INC. MODEL L-1 HEARING AID1Cleared 510(K)
- K971699ARGOSY DYNAMEQ1Cleared 510(K)
- K971605RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION1Cleared 510(K)
- K971296TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-051Cleared 510(K)
- K971032DANAVOX MODELS 163/162 BTE1Cleared 510(K)
- K971031AUDALLION III HEARING SYSTEM1Cleared 510(K)
- K971399AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC1Cleared 510(K)
- K971158DUALINE 400 CIC1Cleared 510(K)
- K971804PHILIPS S1694, S16951Cleared 510(K)
- K971693RIONET HB-79P1Cleared 510(K)
- K971535WIDEX SENSO DIGITAL (MINI CANAL)1Cleared 510(K)
- K971299SCIENTIFIC PLASTICS MODEL SP1Cleared 510(K)
- K970939VISTA V-38 CIC1Cleared 510(K)
- K970880POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN1Cleared 510(K)
- K970828UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMER1Cleared 510(K)
- K970692UNITRON MODEL SOUND F/X CIC1Cleared 510(K)
- K970952PRECISE IMPRESSION KIT1Cleared 510(K)
- K970519UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)1Cleared 510(K)
- K964898IN THE EAR HEARING AID1Cleared 510(K)
- K970262MULTI-CHANNEL COMPRESSION BTE (SD)1Cleared 510(K)
- K970215AUDALLION II HEARING SYSTEM1Cleared 510(K)
- K970537REXTON MODEL 48 AND 49PP1Cleared 510(K)
- K970904WIDEX SENSO DIGITAL (CIC)1Cleared 510(K)
- K965254WIDEX MODEL SENSO DIGITAL (C9)1Cleared 510(K)
- K970430ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCI1Cleared 510(K)
- K970057AHS OMEGA SP1Cleared 510(K)
- K964657SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF1Cleared 510(K)
- K964245PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS1Cleared 510(K)
- K964419MIRACLE - EAR (ITE/ITC/CIC)1Cleared 510(K)
- K965057AUDIOTONE (A554H)1Cleared 510(K)
- K965049DAHLBERG (A-554)1Cleared 510(K)
- K965063AUDIOTONE (A-552)1Cleared 510(K)
- K965218SENSO DIGITAL (C18)1Cleared 510(K)
- K965088M11 SERIES: M11, M11M1Cleared 510(K)
- K964680COMFORTAID HEARING AID1Cleared 510(K)
- K964639TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II1Cleared 510(K)
- K964816AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR1Cleared 510(K)
- K964669MIRACLE-EAR OR AUDIOTONE1Cleared 510(K)
- K964794DAHLBERG K-AMP BTE1Cleared 510(K)
- K964683DIGIFOCUS ITE1Cleared 510(K)
- K964603ARTICULAR HEARING AIDS1Cleared 510(K)
- K963878AHS OMEGA HF1Cleared 510(K)
- K963877AHS OMEGA CONCEPT1Cleared 510(K)
- K963958IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT1Cleared 510(K)
- K964035PHONAK MICROLINK, PERSONAL FM RECEIVER1Cleared 510(K)
- K964557RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION1Cleared 510(K)
- K964530DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT1Cleared 510(K)
- K964503UNITRON MODEL SOUND F/X +41Cleared 510(K)
- K964502UNITRON MODEL SOUND F/XP +41Cleared 510(K)
- K964510UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4)1Cleared 510(K)
- K964511UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4)1Cleared 510(K)
- K964508UNITRON MODEL ICON AOHP +4 (ICON AOHP +4)1Cleared 510(K)
- K964504UNITRON MODEL ICON AOHPL +41Cleared 510(K)
- K964451PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC1Cleared 510(K)
- K964244STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS1Cleared 510(K)
- K964214STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS1Cleared 510(K)
- K963875AHS OMEGA K-AMP1Cleared 510(K)
- K963788PRIMOFOCUS COMPACT1Cleared 510(K)
- K964180AUDIO 'D' SOUND SELECTOR POWER (SSP)1Cleared 510(K)
- K963873AHS OMEGA DEQ1Cleared 510(K)
- K963881AHS DELTA 22 T1Cleared 510(K)
- K963879AHS DELTA 221Cleared 510(K)
- K963876AHS OMEGA PP1Cleared 510(K)
- K963874AHS OMEGA AGC1Cleared 510(K)
- K963745MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR)1Cleared 510(K)
- K963915TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION1Cleared 510(K)
- K964115RESOUND CC4 PERSONAL HEARING SYSTEM1Cleared 510(K)
- K963820OVATION LINEAR1Cleared 510(K)
- K963819OVATION ASP1Cleared 510(K)
- K963818OVATION AGC-21Cleared 510(K)
- K963822OVATION AGC-31Cleared 510(K)
- K963821OVATION AGC-11Cleared 510(K)
- K963604DYNAMIC EQ II - 2 CHANNEL WIDE DYNAMIC RANGE COMPRESSION1Cleared 510(K)
- K963519EUROLINE A-675 SERIS1Cleared 510(K)
- K963607HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL1Cleared 510(K)
- K962388IN THE EAR HEARING AID1Cleared 510(K)
- K963047AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY)1Cleared 510(K)
- K962798AUDIO 'D' K-AMP HR FULL SHELL AND CANAL HEARING AIDS1Cleared 510(K)
- K963122UNITRON MODEL ICON KR1Cleared 510(K)
- K963154RIONET HB-54AS1Cleared 510(K)
- K963152RIONET HB-55AS1Cleared 510(K)
- K963153RIONET HB-55S1Cleared 510(K)
- K962228MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT1Cleared 510(K)
- K962847MT10P, MT60-PP, MT60-AGC0, AND MT601Cleared 510(K)
- K961770PHILIPS 71 SERIES1Cleared 510(K)
- K962170SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP1Cleared 510(K)
- K961907RIONET HEARING AID HB53-K1Cleared 510(K)
- K961827IN-THE-EAR1Cleared 510(K)
- K961729ARGOSY PROGRAMMABLE1Cleared 510(K)
- K961653PHONAK SONA P21Cleared 510(K)
- K961622PHONAK PICONET2 P2 AZ1Cleared 510(K)
- K961670CLARITY1Cleared 510(K)
- K961308AUDIO 'D' INTIMA CIC1Cleared 510(K)
- K961143TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-401Cleared 510(K)
- K961082TECHNA TONE1Cleared 510(K)
- K961059DIGIFOCUS COMPACT1Cleared 510(K)
- K960741COMFORTONE PHS1Cleared 510(K)
- K961084AM 4001Cleared 510(K)
- K960684HEARING AID - AIR CONDUCTION1Cleared 510(K)
- K960680RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES, EDR-EV, & EDR-P11Cleared 510(K)
- K960804MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC1Cleared 510(K)
- K960410PERFECT EAR PE/PE-AGC/PE-B/PE-PWR1Cleared 510(K)
- K960935AUDIO 'D' 2N SERIES HEARING AIDS(FULL SHELL ITE,HALF SHELL ITE, MINI CANAL, CANAL)1Cleared 510(K)
- K960295LONG LIFE RX-121Cleared 510(K)
- K960052RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT2411Cleared 510(K)
- K960284OTICON /PRIMOFOCUS (PF)1Cleared 510(K)
- K960155UNITRON MODEL SOUND F/XP1Cleared 510(K)
- K960031AUDIOFLEX 1201Cleared 510(K)
- K960494EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS1Cleared 510(K)
- K955930BELTONE COMPOSER 2000 BTE HP1Cleared 510(K)
- K955879WIDEX MODEL SENSO DIGITAL (C16)1Cleared 510(K)
- K955702SONATA U-011Cleared 510(K)
- K955466DYNAMEQ-II OPTION1Cleared 510(K)
- K955878WIDEX MODEL SENSO DIGITAL (C8)1Cleared 510(K)
- K955867RESOUND PERSONAL HEARING SYSTEM BT2471Cleared 510(K)
- K955692FINETONE FSC,1Cleared 510(K)
- K955288HEARING AID IMPRESSION MATERIAL1Cleared 510(K)
- K954119MIRACLE EAR MIRAGE1Cleared 510(K)
- K954922REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE INSTRUMENTS1Cleared 510(K)
- K955574RESOUND PERSONAL HEARING SYSTEM BTP W/DAI1Cleared 510(K)
- K954941MIRACLE EAR AND AUDIOTONE1Cleared 510(K)
- K955359CYBER III OPTION UM, UC312, UC10, UCIC1Cleared 510(K)
- K954579TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION1Cleared 510(K)
- K954936BELTONE ULTIMA 80 OTOSONIC POWER PAS1Cleared 510(K)
- K954236FACEPLATE (HEARING AID KIT)1Cleared 510(K)
- K954794OTICON1Cleared 510(K)
- K953603HEARING TODAY HEARING AID1Cleared 510(K)
- K954937COAST HEARING CHS (CUSTOM HEARING SYSTEM)1Cleared 510(K)
- K954526WIDEX SENSO DIGITAL (PX)1Cleared 510(K)
- K954528MIRACLE - EAR MODEL PBP1Cleared 510(K)
- K954516UNITRON MODEL SOUND F/X II1Cleared 510(K)
- K953727UNITRON MODEL IKON AOHPD1Cleared 510(K)
- K953932UNITRON MODEL SOUND F/XD1Cleared 510(K)
- K954430UNITRON MODEL SOUND F/X1Cleared 510(K)
- K9540673M MODEL 82951Cleared 510(K)
- K954054MAICO PRODIGY CIC SERIES1Cleared 510(K)
- K954038K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT1Cleared 510(K)
- K953921PHONAK 9900 CIC1Cleared 510(K)
- K953770REXTON MINI-PRIMO PLUS, PP142, D.C .H.I. FAMILY1Cleared 510(K)
- K951002AMENDMENTS TO MULTIFOCUS1Cleared 510(K)
- K953960HEARING AID (ALL-IN-THE-EAR)1Cleared 510(K)
- K953729K AMP FULL SHELL AND IN THE EAR1Cleared 510(K)
- K953728RX12 LINEAR FULL SHELL AND IN THE CANAL1Cleared 510(K)
- K951712HEARING AID (ALL-IN-THE-EAR)1Cleared 510(K)
- K953646UNITRON MODEL IKON AOHPL1Cleared 510(K)
- K953631SNIP INPUT COMPRESSION CLASS A1Cleared 510(K)
- K9535433M MODEL 8200P MULTIPRO BTE1Cleared 510(K)
- K945439PHONAK PICONET 232X-AZ HEARING INSTRUMENT1Cleared 510(K)
- K953047Z201Cleared 510(K)
- K953050Z331Cleared 510(K)
- K953049Z241Cleared 510(K)
- K953054AM 260 OHM1Cleared 510(K)
- K953053AM 260 PP1Cleared 510(K)
- K953052AM 260 K-AMP1Cleared 510(K)
- K953051Z351Cleared 510(K)
- K953048Z221Cleared 510(K)
- K952986SPI-SECRET PERSONAL INSTRUMENT CIC1Cleared 510(K)
- K952658HEARING AID1Cleared 510(K)
- K953266RESOUND PERSONAL HEARING SYSTEM BT250 MZ W/REMOTE CONTROL OPTION1Cleared 510(K)
- K952940PERSONAL PROGRAMMER 20001Cleared 510(K)
- K952821MWCHAC 95 FS 123451Cleared 510(K)
- K952820MWCHAC 95 C 123451Cleared 510(K)
- K953036DB PUSH-PULL HEARING AID1Cleared 510(K)
- K953038DYNAMIC EQ/CLASS D1Cleared 510(K)
- K953037CUSTOM CANAL & FULL CONCHA INSTR (CLASS D CIR OPT)1Cleared 510(K)
- K951642GOLD CD ULTRA MINI CANAL - MODULE1Cleared 510(K)
- K952450WIDE DYNAMIC RANGE COMPRESSION WITH ACTIVE TONE CONTROL1Cleared 510(K)
- K952452OUTPUT COMPRESSION LIMITER WITH ACTIVE TONE CONTROL1Cleared 510(K)
- K952451CLASS D LINEAR WITH ACTIVE TONE CONTROL1Cleared 510(K)
- K952711LORI-A1Cleared 510(K)
- K951828FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT1Cleared 510(K)
- K951587BELTONE PETITE PLUS BELTONE PETITE PLUS CLEARVIOCE K1Cleared 510(K)
- K946232ACURA-EX1Cleared 510(K)
- K952097OTOSONIC (OSI) CF 10-K, 10-D1Cleared 510(K)
- K950868BELTONE COMPOSER 20001Cleared 510(K)
- K952453INPUT COMPRSSION LIMITER WITH ACTIVE TONE CONTROL1Cleared 510(K)
- K952454EXPANDER WITH ACTIVE TONE CONTROL1Cleared 510(K)
- K952455IMPROVED MANHATTAN II1Cleared 510(K)
- K952229WIDEX MODEL LOGO 32 (L32)1Cleared 510(K)
- K952263PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT1Cleared 510(K)
- K952228SONAR CIC COMPLETELY IN-THE-CANAL HEARING DEVICE1Cleared 510(K)
- K951677RIONET HEARING AID HM-021Cleared 510(K)
- K951896INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT1Cleared 510(K)
- K950963AUDIOTECH MODEL SPI1Cleared 510(K)
- K943808RIONET HM-021Cleared 510(K)
- K943961THE MODEL ACAPPELLA IN THE EAR HEARING AID1Cleared 510(K)
- K951068RESOUND ED4-M MINI-CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-M)1Cleared 510(K)
- K951067RESOUND ED4-C CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-C)1Cleared 510(K)
- K951379RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTION1Cleared 510(K)
- K951378RESOUND PERSONAL HEARING SYSTEM MODELS BTP2 & BTP2/S W/REMOTE CONTROL OPTION1Cleared 510(K)
- K951374RESOUND PERSONAL HEARING SYSTEM BT2/S-E1Cleared 510(K)
- K951375RESOUND PERSONAL HEARING SYSTEM ED3/S-E1Cleared 510(K)
- K951376RESOUND PERSONAL HEARING SYSTEM BT2/S SERIES W/REMOTE CONTROL OPTION1Cleared 510(K)
- K951377RESOUND PERSONAL HEARING SYSTEM BTP/S-A W/REMOTE CONTROL OPTION1Cleared 510(K)
- K946340BELTONE COMPARAFIT1Cleared 510(K)
- K950759UNITRON MODEL ESTEEM1Cleared 510(K)
- K950691MIRACLE-EAR MODEL PBM PROGRAMMABLE HEARING AID1Cleared 510(K)
- K950693MIRACLE-EAR MODEL PM1/PM2 PROGRAMMABLE HEARING AID1Cleared 510(K)
- K950692MIRACLE-EAR MODEL PBS PROGRAMMABLE HEARING AID1Cleared 510(K)
- K950458SILVER ULTRA MINI CANAL1Cleared 510(K)
- K950460GOLD CD ULTRA MINI CANAL1Cleared 510(K)
- K950459GOLD K AMP ULTRA MINI CANAL1Cleared 510(K)
- K950912MEGA-SIL A-B1Cleared 510(K)
- K950758DYNA 231X1Cleared 510(K)
- K950637MAICO IN-THE-EAR MODEL RD-312 CIC1Cleared 510(K)
- K950451M-29 PP-PC, M-29 PP-O/PC1Cleared 510(K)
- K945750RESOUND(R) RESOURCE(TM)1Cleared 510(K)
- K950381OTICON/LOGIC1Cleared 510(K)
- K944896MATRICS IMPRESSION MATERIAL , SYSTEM1Cleared 510(K)
- K944851MICRO MINI PRIMO AGC, MICRO-MINI PRIMO S-AGC1Cleared 510(K)
- K950319RESOUND(R) PERSONAL HEARING SYSTEM ED-3 ENCORE1Cleared 510(K)
- K950080VIP1Cleared 510(K)
- K942107MAGIC EAR, ELAIN1Cleared 510(K)
- K946323UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID1Cleared 510(K)
- K946253MAICO IN-THE-EAR MODEL RD 2011Cleared 510(K)
- K946045OTICON1Cleared 510(K)
- K946071LX-ITC1Cleared 510(K)
- K9457263M(TM) EAR IMPRESSION MATERIAL1Cleared 510(K)
- K946294PHONAK SONO-FORTE 332X-AZ1Cleared 510(K)
- K946264UNITRON MODEL SOUNG F/S1Cleared 510(K)
- K9438543M MODEL 8233 HEARING INSTRUMENT1Cleared 510(K)
- K945219HORMANN HEARING INSTRUMENTS1Cleared 510(K)
- K934917RESOUND PERSONAL HEARING SYSTEMS MODIFICATION1Cleared 510(K)
- K944980SOUND SELECTOR ITE (SSI), BTE (SSB), MINI BTE( SSM)1Cleared 510(K)
- K943380SIEMENS 10A FACEPLATE WITH CIC INSTRUMENTS1Cleared 510(K)
- K944985EMSEE LABS MODE M1Cleared 510(K)
- K944986EMSEE LABS MODEL C1Cleared 510(K)
- K944984EMSEE LABS MODEL S1Cleared 510(K)
- K944777ORION PPM, PP, PP-D1Cleared 510(K)
- K944359EXPRESSION RX-12, ENHANCEMENT RX-34, ELITE RX-121Cleared 510(K)
- K944645SIEMENS FRONTIER SERICE, MODELS S-1,S-2 AND S-3 MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS1Cleared 510(K)
- K944518WIDEX MODEL LOGO 8S1Cleared 510(K)
- K944520AIR CONDUCTION HEARING AID1Cleared 510(K)
- K944404MO4 SERIES1Cleared 510(K)
- K944174LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS1Cleared 510(K)
- K945710IN-THE-EAR HEARING AID1Cleared 510(K)
- K945703WIDEX MODEL LOGO - L91Cleared 510(K)
- K944039BEHIND THE EAR HEARING AID1Cleared 510(K)
- K944043BTP-A HEARING SYSTEM1Cleared 510(K)
- K945780FINETONE DISCEET CANAL1Cleared 510(K)
- K945218ACTIVE MODEL CIC1Cleared 510(K)
- K944161IMAGE1Cleared 510(K)
- K942702DEEP CANAL HEARING INSTRUMENT1Cleared 510(K)
- K943016ADOBE C.I.C1Cleared 510(K)
- K945255MICROSIL1Cleared 510(K)
- K944009HEARING AID (ACCESSORY)1Cleared 510(K)
- K944241MAGNATONE MODEL M PREWIRED FACEPLATE HEARING AID1Cleared 510(K)
- K944097COMPASS SOFTWARE MODULE1Cleared 510(K)
- K942331DANAVOX MODEL CIC1Cleared 510(K)
- K944548REXPLUS PP31Cleared 510(K)
- K944078PROGRAM 3-CH SER HEAR AIDS W/PROGRAM FIT SYST/PRO FIT1Cleared 510(K)
- K944838WIDEX MODEL LX-ITE1Cleared 510(K)
- K944502BELTONE CONCERTO S1Cleared 510(K)
- K943960UV CURED METHYL METHACRYLATE HEARING AID SHELL MATERIALS1Cleared 510(K)
- K943687FEDELITY F495, VIENNATONE ALPP II1Cleared 510(K)
- K944077PROGRAM 3-CH SERIES HEAR AIDS W/DT-1 DESKTOP PROGRAM1Cleared 510(K)
- K943826MIRACLE-EAR MIRAGE1Cleared 510(K)
- K942523MIRACLE-EAR IMPRESSION MATERIAL KIT1Cleared 510(K)
- K943825MIRACLE EAR CONFIDANTE1Cleared 510(K)
- K943788RESOUND PERSONAL HEARING SYSTEM1Cleared 510(K)
- K943318ALL-IN-THE-EAR1Cleared 510(K)
- K935019INFINITY 2521Cleared 510(K)
- K934752SIEMENS MODEL 584 P-21Cleared 510(K)
- K943706AUDILENS LLK1Cleared 510(K)
- K942857SIEMENS BTE HEARING AIDS1Cleared 510(K)
- K943670MO6 SERIES1Cleared 510(K)
- K943682SM-VEGA, SM-PC, SM-AGC, SM-AGC-H1Cleared 510(K)
- K942894MIRACLE-EAR MODEL PGC1Cleared 510(K)
- K942895MIRACLE EAR MODEL PGM1Cleared 510(K)
- K942893MIRACLE-EAR MODEL PGF + REMOTE1Cleared 510(K)
- K943395PHILIPS M38 SERIES1Cleared 510(K)
- K942189CRYSTAL EAR1Cleared 510(K)
- K941107THE CANAL (C.I.C.) AKA/HIDDEN EAR1Cleared 510(K)
- K940667STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AID1Cleared 510(K)
- K940670EARCRAFT HEARING AID1Cleared 510(K)
- K941859MIRACLE-EAR EAR IMPRESSION MATERIAL1Cleared 510(K)
- K943144AURIS CIC1Cleared 510(K)
- K942830HAE 31Cleared 510(K)
- K942831HAE 21Cleared 510(K)
- K942829HAE 11Cleared 510(K)
- K942749HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT1Cleared 510(K)
- K942594STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID1Cleared 510(K)
- K940164SUPER-SIL1Cleared 510(K)
- K942036EUROSTAR SUPER, EUROSTAR VFC1Cleared 510(K)
- K941587HEARING TECH1Cleared 510(K)
- K942213OPTIMA WITH DELTA AMP1Cleared 510(K)
- K942164PHILIPS 61 SERIES1Cleared 510(K)
- K941295SHARP II HELIX HEARING AID1Cleared 510(K)
- K940098BELTONE INVISA1Cleared 510(K)
- K941734PHONAK SONO-FORTE 331X BTE HEARING INSTRUMENTS1Cleared 510(K)
- K932269PRO-CONNECT1Cleared 510(K)
- K941293SHARP II SEMI CONTOUR HEARING AID1Cleared 510(K)
- K941292SHARP II FULL CONTOUR1Cleared 510(K)
- K941294SHARP II LOW PROFILE HEARING AID1Cleared 510(K)
- K941133770-ATC1Cleared 510(K)
- K941122AUDIOTONE MODEL A-54SR1Cleared 510(K)
- K941121AUDIOTONE MODEL A-541Cleared 510(K)
- K941039WAX GUARD OPTION1Cleared 510(K)
- K941635INTRA S, INTRA SH1Cleared 510(K)
- K941636MINI PAK1Cleared 510(K)
- K941508WIDEX S-211Cleared 510(K)
- K941395BELTON MERIT (HEARING AID)1Cleared 510(K)
- K941140RIONET HEARING AID HB-37T1Cleared 510(K)
- K941021RIONET HEARING AID HB-541Cleared 510(K)
- K940978STARKEY EUROLINE A SERIES1Cleared 510(K)
- K940608155 PP AGC-I1Cleared 510(K)
- K935962MIRACLE-EAR WITH POWER CIRCUIT OPTION1Cleared 510(K)
- K940116COMPLETELY IN THE CANAL1Cleared 510(K)
- K936190BEHIND THE EAR HEARING AID1Cleared 510(K)
- K940177OTOSONIC CF-2, CF-2 IC, CF-2 ANF, CF-2 WITH IMPROVED CLASS D (DELTA AMP)1Cleared 510(K)
- K940101OTOSONIC ACS II D WITH SRR1Cleared 510(K)
- K940100PROFILE IC; PROFILE CLEARVOICE; PROFILE1Cleared 510(K)
- K940099OTOSONIC (OSI) LPS D; LPS D IC; LPS D ASP1Cleared 510(K)
- K940102BELTONE OPERA/OPERA MHP/OPERA MAX1Cleared 510(K)
- K940103BELTONE ODE AND BELTONE ODE VX; ODE CLEARVOICE IC AND BELTONE ODE VX CLEARVOICE IC; BELTONE ODE CLEARVOICE ANF AND1Cleared 510(K)
- K940639LORI-CIC HEARING AID1Cleared 510(K)
- K940104OTOSONIC MINI PAS1Cleared 510(K)
- K935867AIR CONDUCTION HEARING AID, UNITRON IKON K & KD1Cleared 510(K)
- K940458MIRACLE-EAR CONFIDANTE1Cleared 510(K)
- K936122RIONET HEARING AID HB-53CI1Cleared 510(K)
- K936106AIR CONDUCTION HEARING AID: IKON PP1Cleared 510(K)
- K935424WIDEX R.C. 2 (REMOTE CONTROL)1Cleared 510(K)
- K934940MIRACLE-EAR ENTRE1Cleared 510(K)
- K936007PRIZM HEARING SYSTEM, MODEL POWER BTE1Cleared 510(K)
- K935559HEARING AIDS HB-36M, HB-36MS, HB-36MT, HI-67P, EXCEL-10001Cleared 510(K)
- K935791PHONAK PICONET 232X-AZ BTE HEARING INSTRUMENT1Cleared 510(K)
- K935327NU.EAR SD-2 IN-THE-CANAL (ITC) HEARING AID1Cleared 510(K)
- K935335NU.EAR SS-10 IN THE CANAL (ITC) HEARING AID1Cleared 510(K)
- K935334NU.EAR SD-1 IN THE EAR (ITE) HEARING AID1Cleared 510(K)
- K935333NU.EAR SS-1 IN THE EAR (ITE) HEARING AID1Cleared 510(K)
- K935332NU.EAR AE-1 IN THE EAR (ITE) HEARING AID1Cleared 510(K)
- K935331NU.EAR SD-3 IN THE CANAL (ITC) HEARING AID1Cleared 510(K)
- K935330NU.EAR SS-3 IN THE CANAL (ITC) HEARING AID1Cleared 510(K)
- K935329NU.EAR AE-2 IN THE CANAL (ITC) HEARING AID1Cleared 510(K)
- K935328NU.EAR SS-2 IN THE CANAL (ITC) HEARING AID1Cleared 510(K)
- K935326NU-EAR SD-10 IN THE CANAL HEARING AID1Cleared 510(K)
- K935366BINAURAL HEARING AID1Cleared 510(K)
- K935458AUDIPHON, MODEL H-111Cleared 510(K)
- K934149MICRO-TECH TRU CANAL1Cleared 510(K)
- K935289PRO FIT-CYBER II OPTION1Cleared 510(K)
- K935420SOUNDRIGHT, SHP1Cleared 510(K)
- K935265MIRACLE EAR MODEL SHARP II CANAL1Cleared 510(K)
- K935266MIRACLE EAR MODEL SHARP II MICRO CANAL HEARING AID1Cleared 510(K)
- K9350958260 SERIES 3M PROGRAMMABLE HEARING INSTRUMENTS1Cleared 510(K)
- K933963PAL (PERSONAL AMPLIFIER FOR LISTENING)1Cleared 510(K)
- K934565UNITRON MODEL IKON AGCO/ AOD1Cleared 510(K)
- K934417OMNI 2000 SERIES ITC HEARING AID1Cleared 510(K)
- K934416OMNI 2000 SERIES ITE HEARING AID1Cleared 510(K)
- K934618OTOSONIC ADVANCED FULL SHIELD (AFS)1Cleared 510(K)
- K934597CLARIFIER II CIRCUIT OPTION1Cleared 510(K)
- K934586PROGRAMMABLE AIR CONDUCTION BEHIND THE EAR HEARING AID1Cleared 510(K)
- K934480RIONET HEARING AID HA-731Cleared 510(K)
- K934479RIONET HEARING AID HA-721Cleared 510(K)
- K931372RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM1Cleared 510(K)
- K933546V-SIL1Cleared 510(K)
- K934452HI BAND1Cleared 510(K)
- K934448POWER 3-CHANNEL-CLOCK1Cleared 510(K)
- K934447LINEAR PLUS-POWER1Cleared 510(K)
- K934446POWER MANHATTAN II1Cleared 510(K)
- K934444K-AMP1Cleared 510(K)
- K9344432:1 INPUT COMPRESSION1Cleared 510(K)
- K934442LINEAR PLUS1Cleared 510(K)
- K9344493-CHANNEL K-AMP1Cleared 510(K)
- K934450MANHATTAN 3-CHANNEL1Cleared 510(K)
- K9344533-CHANNEL CLOCK1Cleared 510(K)
- K934454MANHATTAN II1Cleared 510(K)
- K933988BOSCH EUROSTAR1Cleared 510(K)
- K933989RESOLUTION ITC HEARING AID1Cleared 510(K)
- K933407STARKEY TYMPANETTE HEARING AID1Cleared 510(K)
- K923006AS-901Cleared 510(K)
- K933850PHILIPS 45 SERIES1Cleared 510(K)
- K933644WIDEX MODEL LOGO 8 (L8)1Cleared 510(K)
- K933640WIDEX MODEL LOGO 12 (L12)1Cleared 510(K)
- K933643WIDEX MODEL LOGO 6 (L6)1Cleared 510(K)
- K933579MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING AID1Cleared 510(K)
- K933307MULTIFOCUS COMPACT BTE HEARING AID1Cleared 510(K)
- K933291MAICO BTE MODEL RD-111 AND ITE MODEL RD-312 HEARING AID1Cleared 510(K)
- K932703BELTONE PRIMA 20001Cleared 510(K)
- K930909PRIZM HEARING SYSTEM1Cleared 510(K)
- K932670OTICON MF1Cleared 510(K)
- K933036GOLD ASP MODULE, ITE1Cleared 510(K)
- K933042SILVER COMPRESSION MODULE, ITE1Cleared 510(K)
- K933113STARKEY TRILOGY II PROGRAMMABLE HEARING AID1Cleared 510(K)
- K932734PHONAK PICO-FORTE SC-21Cleared 510(K)
- K932735PHONAK PICO-FORTE SC-D-21Cleared 510(K)
- K933095351-AGCO BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K931942RESOUND PERSONAL HEARING SYSTEM BT-P W/PHS BT-P1Cleared 510(K)
- K932426BELTONE OPERA/OPERA MHP/OPERA MAX1Cleared 510(K)
- K926150VINYL ADDITION SILICONE SYSTEM1Cleared 510(K)
- K932175PHONAK LEXA 231X ITE SERIES HEARING SINSTRUMENT1Cleared 510(K)
- K932058BELTONE OPTIMA 2000 ITE HEARING AID1Cleared 510(K)
- K931881IN THE CANAL AID OTOSONIC ACS II WITH SRR1Cleared 510(K)
- K922502M32 IN THE EAR HEARING AID1Cleared 510(K)
- K922501M30 IN THE EAR HEARING AID1Cleared 510(K)
- K931975AUDIOTECH MODEL DP1Cleared 510(K)
- K932189IN-THE-EAR HEARING AID1Cleared 510(K)
- K932105HEARING AIDS1Cleared 510(K)
- K931984PERFECT EAR/PE1Cleared 510(K)
- K931160SERIES STAR 66 BEKHIND THE EAR HEARING AID1Cleared 510(K)
- K931161SERIES STAR 22 - BEHIND THE EAR HEARING AID1Cleared 510(K)
- K931040MT 80 SP1Cleared 510(K)
- K931035MODELS 33PP, 33PP ANR, & 33PP SUPER HEARING AID1Cleared 510(K)
- K931041STAR 42 PP-SP, STAR 42 PP-SL (T100)1Cleared 510(K)
- K931591ITC MODEL ADOBE 100 CANAL1Cleared 510(K)
- K931590ITE MODEL ADOBE 100 FULL CUSTOM1Cleared 510(K)
- K931320RIONET HEARING AID HB-53W1Cleared 510(K)
- K931023IN-THE-EAR HEARING AID1Cleared 510(K)
- K931157BEHIND-THE-EAR HEARING AID, TELEX MODEL 380-PP1Cleared 510(K)
- K931158MEMOREX MODEL 361-AGCO HEARING AID1Cleared 510(K)
- K931134BEHIND-THE-EAR HEARING AID, TELEX MODEL 361-PP1Cleared 510(K)
- K930999SIEMENS MODEL 584-P-AI1Cleared 510(K)
- K930998SIEMENS MODEL 584-P-GC1Cleared 510(K)
- K931000SIEMENS MODEL 584-P-AI-D1Cleared 510(K)
- K930721RIONET HEARING AID HB-53S1Cleared 510(K)
- K930542HEARING AID (ALL-IN-THE-EAR)1Cleared 510(K)
- K930853INTRA V AND SECRET EAR III1Cleared 510(K)
- K930805CE-9 IN-THE-EAR HEARING AID1Cleared 510(K)
- K930715WIDEX MODEL DX HEARING AID1Cleared 510(K)
- K930598OTOSONIC FSD, IN-THE-EAR HEARING AID1Cleared 510(K)
- K930271BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K930541VOICEMODE, ITE, AIR-CONDUCTION HEARING AID1Cleared 510(K)
- K930310BELTONE OPTIMA 2000 CLEARVOICE SERIES, IN-THE-EAR1Cleared 510(K)
- K930318BELTONE OPERA LOR, ITC1Cleared 510(K)
- K926092MIRACLE-EAR MODEL HL1Cleared 510(K)
- K926091AUDIOTONE MODEL A-981Cleared 510(K)
- K925600VISTA 4000 SIGMA1Cleared 510(K)
- K926476SOUNDCHOICE WITH VARIABLE SLOPE1Cleared 510(K)
- K926085WIDEX MODEL D161Cleared 510(K)
- K930145PHONAK PICONET 231-X1Cleared 510(K)
- K926244WIDEX MODEL D8 (HEARING AID)1Cleared 510(K)
- K924887P54-0 BEHIND THE EAR HEARING AID1Cleared 510(K)
- K924888P54 HEARING AID1Cleared 510(K)
- K924350HEARING AID (ALL-IN-THE-EAR)1Cleared 510(K)
- K925103AAHS HEARING AID1Cleared 510(K)
- K924913PHONAK PICO-FORTE PPC-L-P-2 BTE HEARING INSTR1Cleared 510(K)
- K924914PHONAK PICO-FORTE PPC-P-2 BTE HEARING INSTRUMENT1Cleared 510(K)
- K924911PHONAK PICO-FORTE PP-SC-2 BTE HEARING INSTRUMENT1Cleared 510(K)
- K924912PHONAK PICO-FORTE C-2 BTE HEARING INSTRUMENT1Cleared 510(K)
- K924185DFS GENIUS BTE1Cleared 510(K)
- K924450MEDIPHONIX CUSTOM FULL SHELL CUSTOM CANAL1Cleared 510(K)
- K923292ITC HEARING AID CLUB MODEL LM501Cleared 510(K)
- K923801RIONET HB75-AL BTE AID1Cleared 510(K)
- K923743BTE WITH ACCESSORY ATTACHED1Cleared 510(K)
- K923735SOUNDCHOICE K-AMP1Cleared 510(K)
- K923071DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT1Cleared 510(K)
- K923295ITC HEARING AID CLUB MODEL LM401Cleared 510(K)
- K923293ITC HEARING AID CLUB MODEL LM50H1Cleared 510(K)
- K923296BTE HEARING AID CLUB MODEL ST701Cleared 510(K)
- K923294BTE HEARING AID CLUB MODEL: ST601Cleared 510(K)
- K923986CYBERNETIC OPTION (CYBER I)1Cleared 510(K)
- K923918IN-THE-EAR HEARING AID1Cleared 510(K)
- K923784STARKEY SM SERIES BTE HEARING AIDS1Cleared 510(K)
- K923924VOICEWAVE1Cleared 510(K)
- K923379SIEMENS MODEL INFINITI 1001 B1Cleared 510(K)
- K923380SIEMENS MODEL TRITON 3004 B1Cleared 510(K)
- K921725PHILIP XP SERIES, IN-THE CANAL HEARING AID1Cleared 510(K)
- K923490BTE HEARING AID PERSONIC 4101Cleared 510(K)
- K923491BTE HEARING AID PERSONIC 4251Cleared 510(K)
- K923388BTE HEARING AID OTICON MODEL: MULTIFOCUS POWER1Cleared 510(K)
- K923226EURION LOTOS PP HEARING AID1Cleared 510(K)
- K922392ITE, ITC, OE(OPEN), HS(HALF SHELL) HEARING AID1Cleared 510(K)
- K905555A-ZILICONE1Cleared 510(K)
- K922827OTOSONIC ACS K1Cleared 510(K)
- K922708WIDEX MODEL D321Cleared 510(K)
- K922422PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES1Cleared 510(K)
- K922301BELTONE OPERA CLEARVOICE IC, ITC (IN THE CANAL)1Cleared 510(K)
- K915711IN THE EAR HEARING AID1Cleared 510(K)
- K922224OTOSONIC ACS-IC1Cleared 510(K)
- K921463PHILIPS 31 SERIES IN THE EAR HEARING AID1Cleared 510(K)
- K922066TELEX MODEL 28A ITE CUSTOM HEARING AID1Cleared 510(K)
- K922065TELEX MODEL M29 ITE CUSTOM HEARING AID1Cleared 510(K)
- K921257EURION LOTOS P HEARING AID1Cleared 510(K)
- K921656LIFESOUND ITE (LSI-I)W/ TRITON 3004I PROGRAMMABLE1Cleared 510(K)
- K921829RIONET HEARING AID HB-52S1Cleared 510(K)
- K921830RIONET HEARING AID HB-52T1Cleared 510(K)
- K920911QCC CUSTOM CANAL AND QE1 ALL ITE1Cleared 510(K)
- K920657DI CUSTOM IN THE EAR AND IN THE CANAL1Cleared 510(K)
- K921122SOUNDCHOICE BTE1Cleared 510(K)
- K921023BELTONE OPRA CLEAR VOICE-K HEARING AID1Cleared 510(K)
- K920897RIONET HEARING AID - HB 52DU1Cleared 510(K)
- K915794AD-HEAR1Cleared 510(K)
- K912399HEARING AID (ALL-IN-THE-EAR)1Cleared 510(K)
- K920466EXTEND-EAR1Cleared 510(K)
- K915450IN THE EAR HEARING AID1Cleared 510(K)
- K920521RIONET HEARING AID HB-23T1Cleared 510(K)
- K920522RIONET HEARING AID HB-23M1Cleared 510(K)
- K914948AM 300 AGC-O1Cleared 510(K)
- K914947AM 300 XP1Cleared 510(K)
- K914796PREMIER ASP/CD RECHARGEABLE1Cleared 510(K)
- K914799PREMIER K-AMP1Cleared 510(K)
- K914795ELECTONE/PA RECHARGEABLE1Cleared 510(K)
- K914798PREMIER CLASS D-ASP1Cleared 510(K)
- K914797PREMIER CD RECHARGEABLE1Cleared 510(K)
- K920486RIONET HEARING AID HB-53P1Cleared 510(K)
- K920093AUDIOTONE MODEL A-961Cleared 510(K)
- K920134PHILIPS 41 SERIES RAINBOW1Cleared 510(K)
- K915614BTE HEARING AID MULTIFOCUS1Cleared 510(K)
- K920142PHILIPS M60 SERIES1Cleared 510(K)
- K915346CUSTOM CANAL HEARING AID1Cleared 510(K)
- K915875RIONET HEARING AID HB-71K (K-AMP)1Cleared 510(K)
- K914897SONOTONE BEHIND THE EAR MODEL ST 54-01Cleared 510(K)
- K915684REXTON RX34 WITH HORIZON PROGRAMMABLE OPTION1Cleared 510(K)
- K915683REXTON RX12 WITH HORIZON PROGRAMMABLE OPTION1Cleared 510(K)
- K915319RIONET HEARING AID HB-52AS1Cleared 510(K)
- K915519SONOTONE BEHIND THE EAR MODEL ST 53A1Cleared 510(K)
- K915517SONOTONE BODY AID MODEL ST 1000 BODY WORN1Cleared 510(K)
- K915518SONOTONE BEHIND THE EAR MODEL ST 491Cleared 510(K)
- K915076MED-EQUIP CORPORATION1Cleared 510(K)
- K914899SONOTONE BEHIND THE EAR MODEL ST 45G1Cleared 510(K)
- K914898SONOTONE BEHIND THE EAR MODEL ST 47I1Cleared 510(K)
- K915461PHONAK 9000-AF ITE HEARING INSTRUMENT SERIES1Cleared 510(K)
- K915252PHILIPS P74P BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K914981OTOSONIC (OSI) LPS IN-THE-EAR HEARING AID1Cleared 510(K)
- K914982BELTONE PROFILE IN-THE-EAR HEARING AID1Cleared 510(K)
- K914940BELTONE CLEARVOICE1Cleared 510(K)
- K914939OTOSONIC ACS-ASP1Cleared 510(K)
- K914800P54 BTE HEARING AID1Cleared 510(K)
- K914689HEARING AID, UNITRON MODEL VISTA 40001Cleared 510(K)
- K914688HEARING AID, UNITRON MODEL VISTA 30001Cleared 510(K)
- K913366IN-THE-EAR HEARING AIDS1Cleared 510(K)
- K914477AUDIOTONE MODEL A-95 BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K914418ACT-II BEHIND THE EAR HEARING AID1Cleared 510(K)
- K913245MODEL 80 HEARING AID DISPENSING SYSTEM1Cleared 510(K)
- K914333SIEMENS MODEL LS-I W/INFINITI PROGRAMMABLE OPTION1Cleared 510(K)
- K914017UC312, ULTRA MINIATURE ITC HEARING AID1Cleared 510(K)
- K913771ELEGANCE - KED, BEHIND THE EAR HEARING AID1Cleared 510(K)
- K913781QUALITONE 48PP-AGC-I, BEHIND THE EAR HEARING AID1Cleared 510(K)
- K913592QUALITONE 46PP-AGC-I1Cleared 510(K)
- K913503PHONAK PICO-FORTE PP-C-P BTE HEARING INSTRUMENT1Cleared 510(K)
- K913502PHONAK AUDINET PP-C-P BTE HEARING INSTRUMENT1Cleared 510(K)
- K913390M32 IN-THE-EAR HEARING AID1Cleared 510(K)
- K913389PHILIPS S1594 OTB HEARING AID1Cleared 510(K)
- K912870HEARING AID, UNITRON MODEL UIK1Cleared 510(K)
- K912665SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID1Cleared 510(K)
- K911183NHS 2044P BODY AID, HEARING AID1Cleared 510(K)
- K912571PHONAK PHONICA MODEL 312-SC ITE HEARING INSTRUMENT1Cleared 510(K)
- K912570PHONAK PHONICA MODEL 312-C ITE HEARING INSTRUMENT1Cleared 510(K)
- K911811SIEMENS MODEL 604 PP-L, BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K911810SIEMENS MODEL 604 PP, BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K912204TELEX MODEL TLP, IN-THE-EAR1Cleared 510(K)
- K912153QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR1Cleared 510(K)
- K912154QUALITONE MODEL 48 C-WR-BEHIND THE EAR1Cleared 510(K)
- K912339PHILIPS M30 IN-THE-EAR HEARING AID1Cleared 510(K)
- K912169WIDEX MODEL QX IN-THE-EAR HEARING AID1Cleared 510(K)
- K911708MODEL E-50, IN-THE-EAR HEARING AID1Cleared 510(K)
- K911709STOCK CANAL, IN-THE-EAR HEARING AID1Cleared 510(K)
- K911707REGAL, BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K911706MODEL 800, BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K911705CHAMPION, BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K911174NHS 2009SP HEARING AID1Cleared 510(K)
- K911182NNHS 2050 SERIES (2055W-2054PP) HEARING AIDS1Cleared 510(K)
- K911579STARKEY TRILOGY PROGRAM HEAR AID CC/CE MODELS1Cleared 510(K)
- K911504ULTRA & ULTRA LITE II, MODIFICATION1Cleared 510(K)
- K911497CUSTOM PERSONAL EAR - CPE1Cleared 510(K)
- K911498ADJUSTRETTE - DAO, MODIFICATION1Cleared 510(K)
- K911499ELEGANCE - DEO, MODIFICATION1Cleared 510(K)
- K911210PHONAK 9800 SC-AF ITE HEARING INSTRUMENT1Cleared 510(K)
- K911211PHONAK 9100 SC-AF ITE HEARING INSTRUMENT1Cleared 510(K)
- K911209PHONAK 9300 SC-AF ITE HEARING INSTRUMENT1Cleared 510(K)
- K910325AHL, ITE MODEL AMERICAN1Cleared 510(K)
- K905516MODEL FT40 TRANSONIC(TM) HEARING AID1Cleared 510(K)
- K910097ELECTONE ITE MODEL PREMIER1Cleared 510(K)
- K905740RESORBABLE BONE PLUG1Cleared 510(K)
- K911096DAHLBERG MODEL LZ BTE HEARING AID1Cleared 510(K)
- K911064DAHLBERG MODEL LG BTE HEARING AID1Cleared 510(K)
- K911063DAHLBERG MODEL LU BTE HEARING AID1Cleared 510(K)
- K910979DAHLBERG MODEL LT BTE HEARING AID1Cleared 510(K)
- K910809DAHLBERG MODEL LB BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K910313ABRA IPC MODEL INPUT COMPRES AGCCUST ITE HEAR AID1Cleared 510(K)
- K910312C ABRA MODEL LINEAR, LOW DRAIN CUST CANAL HEAR AID1Cleared 510(K)
- K910311ABRA MODEL LINE LOW DRAIN CUST IN-THE-EAR HEAR AID1Cleared 510(K)
- K910314C ABRA MODEL LINEAR, LOW DR. CUSTOM CANAL HEAR AID1Cleared 510(K)
- K905784CUSTOM ITE HEARING AID1Cleared 510(K)
- K905371ITE HEARING AID1Cleared 510(K)
- K904756MATRICS1Cleared 510(K)
- K9106903M MODEL 8240 ITE HEARING AID1Cleared 510(K)
- K910028POST AURICULAR HEARING AID MODEL PICO SC-H1Cleared 510(K)
- K905680543 SERIES BTE1Cleared 510(K)
- K910743PHILIPS MODEL S46-OL BTE HEARING AID1Cleared 510(K)
- K910744PHILIPS MODEL S46-O BTE HEARING AID1Cleared 510(K)
- K910705ACTIVE MODEL AHX HELIX ITE HEARING AID1Cleared 510(K)
- K910704ACTIVE MODEL AMC MINI CANAL ITE HEARING AID1Cleared 510(K)
- K910703ACTIVE MODEL ACA CUSTOM CANAL ITE HEARING AID1Cleared 510(K)
- K910702ACTIVE MODEL AHS HALF SHELL ITE HEARING AID1Cleared 510(K)
- K910701ACTIVE MODEL ALP LOW PROFILE ITE HEARING AID1Cleared 510(K)
- K910700ACTIVE MODEL AST CUSTOM ITE HEARING AID1Cleared 510(K)
- K9107593M MODEL 8241 ITE HEARING AID1Cleared 510(K)
- K9107633M MODEL 8245 ITE HEARING AID1Cleared 510(K)
- K9107623M MODEL 8244 ITE HEARING AID1Cleared 510(K)
- K9107613M MODEL 8243 ITE HEARING AID1Cleared 510(K)
- K9107603M MODEL 8242 ITE HEARING AID1Cleared 510(K)
- K910018POST AURICULAR HEARING AID MODEL PICO-FORTE PP-SC1Cleared 510(K)
- K910012PHONAK MODEL PICO C-S-H-T, BTE HEARING AID1Cleared 510(K)
- K910206PHILIPS MODEL S47 BTE HEARING AID1Cleared 510(K)
- K910148AM130 AGC-O (BEHIND THE EAR) HEARING AID1Cleared 510(K)
- K910099ELECTONE BTE MODEL AM 240 HF1Cleared 510(K)
- K910096ELECTONE BTE MODEL AM900 PP1Cleared 510(K)
- K910100ELECTONE BTE MODEL AM 130 D1Cleared 510(K)
- K910101ELECTONE BTE MODEL AM 130 PP1Cleared 510(K)
- K910102ELECTONE BTE MODEL AM 240 PPL1Cleared 510(K)
- K910103ELECTONE BTE MODEL AM 130 HF1Cleared 510(K)
- K910098ELECTONE BTE MODEL AM 240 PPI1Cleared 510(K)
- K905692143 SERIES BTE1Cleared 510(K)
- K905679133 SERIES BTE1Cleared 510(K)
- K905483MEMORYMATE MODEL 8270 ITE HEARING AID1Cleared 510(K)
- K903145HEARSET TELEPHONE HEARING SYSTEM1Cleared 510(K)
- K904731QUALITONE ITE GENESIS1Cleared 510(K)
- K904020MEMORYMATE HEARING AID WITH PMC PROGRAMMER1Cleared 510(K)
- K904730QUALITONE ULTRA CANAL GENESIS1Cleared 510(K)
- K904576HEARING AID, UNITRON MODEL UM60-UH1Cleared 510(K)
- K903473BEST LABS MODEL S1Cleared 510(K)
- K903474BEST LABS MODEL C1Cleared 510(K)
- K903472BEST LABS MODEL M1Cleared 510(K)
- K903471BEST LABS MODEL P1Cleared 510(K)
- K904673OTICAON BTE MODEL E34P1Cleared 510(K)
- K902846PRIZM HEARING SYSTEM1Cleared 510(K)
- K903583SERIES MCAXX (MODEL 851) ITE HEARING AID1Cleared 510(K)
- K903479AUDIOTECH MODEL DB1Cleared 510(K)
- K903478AUDIOTECH MODEL CL1Cleared 510(K)
- K903863ITE HEARING AID, SOUND MED OPAL MODEL1Cleared 510(K)
- K903861ITE HEARING AID, SOUND MED GOLDEN NUGGET MODEL1Cleared 510(K)
- K903860ITE HEARING AID, SAAPHIRE MODEL1Cleared 510(K)
- K903859ITE HEARING AID, DIAMOND MODEL1Cleared 510(K)
- K903415ITE HEARING AID, SOUND MED EMERALD MODEL1Cleared 510(K)
- K903865ITE HEARING AID, SOUND MED AMETHYST MODEL1Cleared 510(K)
- K903864ITE HEARING AID, PEARL MODEL1Cleared 510(K)
- K903862ITE HEARING AID, SOUND MED RUBY MODEL1Cleared 510(K)
- K902487MODIFIED HEARING AID (IN-THE-EAR)1Cleared 510(K)
- K903760MODEL TRITON 3000 BTE HEARING AID AND PMC SYSTEM1Cleared 510(K)
- K900632DYNASTY HEARING SYSTEMS INSTRUMENT1Cleared 510(K)
- K903295ESCORT ITC1Cleared 510(K)
- K902179VISTA - MODELS V12, V20, V23, V38, ITE HEARING AID1Cleared 510(K)
- K901833CE-8 CUSTOM IN-THE-EAR HEARING AIDS1Cleared 510(K)
- K902290ITE HEARING AID MODEL PALOMINO1Cleared 510(K)
- K903023HERITAGE III (HTC) ITC TYPE HEARING AID1Cleared 510(K)
- K901341REXTON RX12 POWER PLUS W/DUAL RECEIVER1Cleared 510(K)
- K901860INTRA III AND INTRA IV HEARING AIDS1Cleared 510(K)
- K902559CUSTOM IN-THE-EAR HEARING AID OTICON MODEL: P1Cleared 510(K)
- K902570ADAM MARK II CUSTOM IN-THE-EAR HEARING AID1Cleared 510(K)
- K902351CUSTOM ITE HEARING AID MODELS C AND M1Cleared 510(K)
- K902352CUSTOM ITE HEARING AID MODEL: H1Cleared 510(K)
- K902353CUSTOM ITE HEARING AID MODELS F AND L1Cleared 510(K)
- K901745AUDIOTONE MODEL A-52S BEHIND-THE-EAR HEARING INST.1Cleared 510(K)
- K901783AUDIOTONE ITE HEARING AID MODEL ZA (MICRO)1Cleared 510(K)
- K901747AUDIOTONE ITE HEARING AID MODEL ZG (MIRAGE)1Cleared 510(K)
- K901746AUDIOTONE ITE HEARING AID MODEL ZD (XT)1Cleared 510(K)
- K901642WIDEX HEARING AID MODEL THE DISCOVERY1Cleared 510(K)
- K900846MODEL 366 HEARING AID1Cleared 510(K)
- K900831BTE PICO SCD, PICO SC1Cleared 510(K)
- K900829BTE SUPER-FRONT PPSCL, SUPER-FRONT PPSC1Cleared 510(K)
- K900830BTE SUPER-FRONT PPCL4, SUPER-FRONT PPC41Cleared 510(K)
- K900675PHONAK ITE 8000, 7000, 6000 ITE HEARING AID1Cleared 510(K)
- K897033WIDEX BTE HEARING AID MODEL Q16 WITH REMOTE1Cleared 510(K)
- K897035MIRACLE EAR MODEL PC PROG. IN-THE-EAR HEARING AID1Cleared 510(K)
- K893573SIEMENS MODEL 284 PP-L1Cleared 510(K)
- K893575SIEMENS MODEL 283 ASP1Cleared 510(K)
- K893576SIEMENS MODEL 284 PP1Cleared 510(K)
- K893574SIEMENS MODEL 284 PP-AGC1Cleared 510(K)
- K897154NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE1Cleared 510(K)
- K896995DISCRETION, IN THE CANAL HEARING INSTRUMENT1Cleared 510(K)
- K901351SEARS MODEL 9098 ITE HEARING AID1Cleared 510(K)
- K901350SEARS MODEL 9094 ITE HEARING AID1Cleared 510(K)
- K901569BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL1Cleared 510(K)
- K901556AUDIOTONE MODEL FFI ITE HEARING AID1Cleared 510(K)
- K897024MODEL AUDINA ITE HEATING AID1Cleared 510(K)
- K891556EXAM GLOVES (VINYL) MFG. GLORIOUS WEALTH CO.1Cleared 510(K)
- K901469SEARS MODEL LF9096 IN-THE-EAR HEARING INSTRUMENT1Cleared 510(K)
- K901470SEARS MODEL JCS IN-THE-EAR HEARING INSTRUMENT1Cleared 510(K)
- K901388SEARS MODEL LM9091 IN-THE-EAR HEARING INSTRUMENT1Cleared 510(K)
- K901387SEARS MODEL LI9097 IN-THE-EAR HEARING INSTRUMENT1Cleared 510(K)
- K901389SEARS MODEL LC9092 IN-THE-EAR HEARING INSTRUMENT1Cleared 510(K)
- K895843AHAC ITE MODEL ENTENDRE1Cleared 510(K)
- K901386SEARS MODEL LS9093 IN-THE-EAR HEARING INSTRUMENT1Cleared 510(K)
- K900862DAHLBERG MODEL JM IN-THE-EAR HEARING INSTRUMENT1Cleared 510(K)
- K901316WIDEX MODEL Q9, BTE W/QUATRO REMOTE CONTROL1Cleared 510(K)
- K901317WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL1Cleared 510(K)
- K901292OTICON BTE HEARING AID (BEHIND-THE-EAR), MODEL E441Cleared 510(K)
- K900968HEARING AID (ALL-IN-THE-EAR)1Cleared 510(K)
- K900861DAHLBERG MODEL JH IN-THE-EAR HEARING INSTRUMENT1Cleared 510(K)
- K900789HEARING AID (ALL-IN-THE-EAR)1Cleared 510(K)
- K900636REXTON PP 142, PP 142-L1Cleared 510(K)
- K895981WIDEX HEARING AID MODELS ES9T AND ES9H1Cleared 510(K)
- K895982WIDEX HEARING AID MODEL ES 10 ASP T1Cleared 510(K)
- K900692DAHLBERG MODEL JMS IN-THE-EAR HEARING INSTRUMENT1Cleared 510(K)
- K900050MIRACLE EAR MODEL CK IN-THE-EAR HEARING AID1Cleared 510(K)
- K893004HEARING AID (ALL-IN-THE-EAR)1Cleared 510(K)
- K895368IN THE EAR HEARING AID1Cleared 510(K)
- K900238MIRACLE EAR MODEL SK IN-THE-EAR HEARING AID1Cleared 510(K)
- K900237MIRACLE EAR MODEL SM IN-THE-EAR HEARING AID1Cleared 510(K)
- K896463RESOUND CUSTOM IN-THE CANAL HEARING AID MODEL CA11Cleared 510(K)
- K893887BESTONE MODEL ITE & CANAL1Cleared 510(K)
- K896159DAHLBERG MODEL LP BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K896157DAHLBERG MODEL LH BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K896158DAHLBERG MODEL LA BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K896057MINI PRIMO PLUS ASP BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K896056REXTON RX12D CUSTOM IN-THE-EAR HEARING AID1Cleared 510(K)
- K895590ITE HEARING AID MODEL PA1Cleared 510(K)
- K895517AURAL-TECH ITE HEARING AID MODEL AT-1S, 1SA, 1SC1Cleared 510(K)
- K891914ITC PRESCRIPTION SERIES MODEL CA AND C1Cleared 510(K)
- K894176FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA1Cleared 510(K)
- K8951343M INSTANT FIT CUSTOM EARMOLD1Cleared 510(K)
- K894428HEARING AID (IN-THE-EAR)1Cleared 510(K)
- K895140CUSTOM IN-THE-CANAL (ITC) HEARING AID MODEL I541Cleared 510(K)
- K894414HEARING AID (IN-THE-CANAL)1Cleared 510(K)
- K893723LORI-MODEL L, CANAL IN-THE-EAR INSTRUMENT1Cleared 510(K)
- K893722LORI-MODEL H, HALF CONCHA IN-THE-EAR INSTRUMENT1Cleared 510(K)
- K893721LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT1Cleared 510(K)
- K893528OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID1Cleared 510(K)
- K892898ASTRO BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K893927RESOUND CUSTOM IN-THE CANAL HEARING AID PHS-31Cleared 510(K)
- K893432PERSONAL AMPLIFIER RECHARGEABLE MODEL TRIUMPH II1Cleared 510(K)
- K892338BEHIND-THE-EAR HEARING AID MODEL 48 AGCI1Cleared 510(K)
- K891915ITE PRESCRIPTION SERIES MODEL LP1Cleared 510(K)
- K891916ITE PRESCRIPTION SERIES MODEL PP + F1Cleared 510(K)
- K892803PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,9111Cleared 510(K)
- K890271ALPHA MODEL I ITE HEARING AID1Cleared 510(K)
- K893433PERSONAL AMPLIFIER MODEL ULTRA HELIX1Cleared 510(K)
- K892460TELSTAR MODEL PP ITE HEARING AID1Cleared 510(K)
- K892458TELSTAR MODEL F ITE HEARING AID1Cleared 510(K)
- K892457TELSTAR MODEL 1/3 ITE HEARING AID1Cleared 510(K)
- K892459TELSTAR MODEL C ITE HEARING AID1Cleared 510(K)
- K892336BEHIND-THE-EAR HEARING AID MODEL 48 PP PC1Cleared 510(K)
- K892333REXTON RX12PP, RX20PP & RX34PP IN-THE-EAR HEAR AID1Cleared 510(K)
- K890525INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA1Cleared 510(K)
- K890102ITC & ITE HEARING AID, HEAR CLEAR MODELS 1-41Cleared 510(K)
- K892337BEHIND-THE-EAR HEARING AID MODEL 46 PP PC1Cleared 510(K)
- K891594CERUMEN FILTER1Cleared 510(K)
- K891251BEHIND-THE-EAR HEARING AID MODEL 408 W-H1Cleared 510(K)
- K891250BEHIND-THE-EAR HEARING AID MODEL 264 D-PP-PC1Cleared 510(K)
- K891249BEHIND-THE-EAR HEARING AID MODEL 303 ASP1Cleared 510(K)
- K891248BEHIND-THE-EAR HEARING AID MODEL 304 PP-AGC-I1Cleared 510(K)
- K891011RESOUND ITC HEARING ENHANCEMENT SYS HES2, W/REMOTE1Cleared 510(K)
- K884997ITE HEARING AID PARKER/TECHNITONE, MODEL PA1Cleared 510(K)
- K890703CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A1Cleared 510(K)
- K890704BTE HEARING AID OTICON MODEL: E42P1Cleared 510(K)
- K885128WIDEX BTE HEARING AID MODEL Q81Cleared 510(K)
- K884871RESOUND HES, DIGITALLY PROGR., ITE HEARING AID1Cleared 510(K)
- K884583BTE HEARING AID SIEMENS MODEL 284PP-ASP1Cleared 510(K)
- K882633ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID1Cleared 510(K)
- K884288HEARING AID, UNITRON BTE MODEL UM60-AGC01Cleared 510(K)
- K884113HEARING AID WIDEX BTE1Cleared 510(K)
- K883772H.A.C. MODEL-A (ALL IN THE EAR)1Cleared 510(K)
- K883773H.A.C. MODEL-B (ALL IN THE CANAL)1Cleared 510(K)
- K883961UNIMAX(TM) HEARING AID BTE MODELS:100S, 110C, PPS41Cleared 510(K)
- K882678ITE HEARING AID, SIEMENS MODEL 007, WITH TELOS1Cleared 510(K)
- K882721ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR1Cleared 510(K)
- K883513HEARING AID, UNITRON MODEL VISTA 10001Cleared 510(K)
- K882691MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX1Cleared 510(K)
- K882471ITE HEARING AID, EARTECH/CUSTOM AID MODEL CA1Cleared 510(K)
- K881480FIRST AMERICAN, RADIONIC, JKR, MODEL AC1Cleared 510(K)
- K882375HEARING AID, UNITRON MODEL UI51Cleared 510(K)
- K881299ITE HEARING AID, EAR-TRONICS MODELS: M1-M231Cleared 510(K)
- K881754ITE TYPE HEARING AID H.A.F. MODEL ELITE1Cleared 510(K)
- K882692MODEL P20/P21 IN-THE-EAR HEARING AID1Cleared 510(K)
- K882005HARMONY HEARING AID MODELS LP, M, HO, HF, & C1Cleared 510(K)
- K882150HEARING AID (ALL-IN-THE-EAR)1Cleared 510(K)
- K881417DAHLBERG MODEL GP BODY AID1Cleared 510(K)
- K882004AUDINA1Cleared 510(K)
- K881612DAHLBERG MODEL XJ 8080 BODY-WORN HEARING AID1Cleared 510(K)
- K881193ACCUTONE IN-THE-EAR HEARING AID1Cleared 510(K)
- K881143IMPULSE TVC (RICHARDS, OMNI, MARCON)1Cleared 510(K)
- K881738AUDIOTONE MODEL TLC SECRET IN-THE-EAR HEARING AID1Cleared 510(K)
- K881737AUDIOTONE MODEL AVATAR IN-THE-EAR HEARING AID1Cleared 510(K)
- K881653AUDIOTONE MODEL ASP SECRET IN-THE-EAR HEARING AID1Cleared 510(K)
- K880938ITE TYPE HEARING AID ABS MODEL1Cleared 510(K)
- K881652AUDIOTONE MODEL A-61 BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K881296HEARING AID (ALL-IN-THE-EAR)1Cleared 510(K)
- K880969STAR 22,33,66 SERIES & STARKEY H. AND SM SERIES1Cleared 510(K)
- K880333CUSTOM I.T.E. HEARING AIDS CE-5, CE-6, CE-71Cleared 510(K)
- K880335INTRA II SECRET EAR HEARING AIDS ISE1Cleared 510(K)
- K880334CUSTOM CANAL HEARING AIDS INTRA II CC-5, 6 & 71Cleared 510(K)
- K880273WIDEX HEARING AID MODEL C11Cleared 510(K)
- K880223MAGIC EAR MODEL MB BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K880635IN THE EAR HEARING AID1Cleared 510(K)
- K880225MAGIC EAR MODEL CI IN-THE-EAR HEARING AID1Cleared 510(K)
- K880184VIBRASOUND IN-THE-EAR HEARING AID1Cleared 510(K)
- K880082MEMORYMATE HEARING AID MODEL 82001Cleared 510(K)
- K880349MODEL 759 CUSTOM IN-THE-EAR HEARING AID1Cleared 510(K)
- K880224MAGIC EAR MODEL MC BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K880284ADDVANTAGE:TVC MARCON1Cleared 510(K)
- K880465SERIES S515/S525 BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K880466SERIES S415/S425 - BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K880286OMNI ITC TYPE HEARING AID MODEL U-IMPULSE SP1Cleared 510(K)
- K880285RICHARDS ITC TYPE HEARING AID MODEL IMPULSE SP1Cleared 510(K)
- K875010IN-THE-EAR HEARING AID1Cleared 510(K)
- K874510RIONET HEARING AID HB-751Cleared 510(K)
- K874831AUDIOTONE MODEL A2000 BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K874830MIRACLE EAR MODEL BP BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K874651OTICON HEARING AID MODEL I521Cleared 510(K)
- K874369CONCHA, CAVUM, CANAL, CONCHA-P HEARING AID1Cleared 510(K)
- K874384AUDIOTONE MODEL A-90, BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K875009IN-THE-EAR HEARING AID1Cleared 510(K)
- K874385AUDIOTONE MODEL MSP, IN-THE-EAR HEARING AID1Cleared 510(K)
- K874380BTE HEARING AID OTICON MODEL E38P1Cleared 510(K)
- K874381BTE HEARING AID OTICON MODEL E39PL1Cleared 510(K)
- K874707POST AURICULAR HEARING AID 46PP-PC SUMMIT1Cleared 510(K)
- K874218HEARING AID (ALL-IN-THE-EAR)1Cleared 510(K)
- K874764HEARING AID (ALL-IN-THE-EAR) MODEL WORD SORTER1Cleared 510(K)
- K874744OTICON MODEL I50 IN-THE-EAR HEARING AID1Cleared 510(K)
- K873736NICOLET DIGITAL TWO PIECE HEARING AID1Cleared 510(K)
- K873003HEARING AID (ALL-IN-THE-EAR)1Cleared 510(K)
- K874589BERNAFON COLIBRI, C-2H HEARING AIDS1Cleared 510(K)
- K874323MODEL A-70, BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K874304PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL1Cleared 510(K)
- K874324MODEL A-17, BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K874325MODEL A-72, BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K873490HEARING AID (ALL-IN-THE-EAR)1Cleared 510(K)
- K873798INTERNATIONAL MODEL XP BEHIND-THE-EAR1Cleared 510(K)
- K873799INTERNATIONAL MODEL XL BEHIND-THE-EAR1Cleared 510(K)
- K873800INTERNATIONAL MODEL XM BEHIND-THE-EAR1Cleared 510(K)
- K873559U-IMPULSE TVC AIR CONDUCTION HEARING AID1Cleared 510(K)
- K873560U-IMPULSE AIR CONDUCTION IN-THE-CANAL HEARING AID1Cleared 510(K)
- K873468CUSTOM IN-THE-EAR HEARING AID SERIES MCA201Cleared 510(K)
- K873210TELSTAR MODEL PP1Cleared 510(K)
- K873189HEARING AID (ALL-IN-THE-EAR)1Cleared 510(K)
- K873169DAHLBERG MODEL GH BODY AID1Cleared 510(K)
- K872995HEARING AID (ALL IN THE EAR)1Cleared 510(K)
- K872977HEARING AID (ALL-IN-THE-EAR)1Cleared 510(K)
- K872922IN THE EAR HEARING AID1Cleared 510(K)
- K873070HEARING AID (IN-THE-EAR)1Cleared 510(K)
- K873397DAHLBERG MODEL MH BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K873376MODEL SI AND SP BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K873338HORN CUSTOM AID1Cleared 510(K)
- K873001HEARING AID (ALL-IN-THE-EAR)1Cleared 510(K)
- K872647INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EAR1Cleared 510(K)
- K872152SIEMENS SILICONE IMPRESSION MATERIAL1Cleared 510(K)
- K872552HEARING-AID1Cleared 510(K)
- K872374WIDEX HEARING AID MODEL ES11Cleared 510(K)
- K872372BEHIND-THE-EAR HEARING AID OTICON E401Cleared 510(K)
- K872348HEARING AID1Cleared 510(K)
- K872474POST-AURICULAR HEARING AID MODEL PE 805 SCD21Cleared 510(K)
- K872473POST-AURICULAR HEARING AID MODEL PE 805CD21Cleared 510(K)
- K872375WIDEX HEARING AID MODEL ES61Cleared 510(K)
- K872556HEARING AID M35/M36 SERIES1Cleared 510(K)
- K872554HEARING AID 49 SERIES1Cleared 510(K)
- K872553HEARING AID S45 SERIES1Cleared 510(K)
- K872555HEARING AID 47 SERIES1Cleared 510(K)
- K872212HEARING AID (ALL-IN-THE-EAR)1Cleared 510(K)
- K872017BTE HEARING AID OTICON MODEL E30P1Cleared 510(K)
- K871520TELSTAR MODEL FS HEARING AID1Cleared 510(K)
- K871518TELSTAR MODEL F3TS HEARING AID1Cleared 510(K)
- K871522TELSTAR MODEL C HEARING AID1Cleared 510(K)
- K871521FULL SHELL ITE HEARING AID1Cleared 510(K)
- K871519TELSTAR MODEL 0/3 HEARING AID1Cleared 510(K)
- K871525DAHLBERG MODEL UL IN-THE-EAR HEARING AID1Cleared 510(K)
- K871524DAHLBERG MODEL UH IN-THE-EAR HEARING AID1Cleared 510(K)
- K871205CUSTOM IN-THE-EAR HEARING AID1Cleared 510(K)
- K8709853M INSTANT FIT CUSTOM EARMOLD1Cleared 510(K)
- K870982HEARING AID1Cleared 510(K)
- K870723HEARTECH HFX, HEARING AID1Cleared 510(K)
- K870691DAHLBERG MODEL UV TRIMLINE IN-THE-EAR HEARING AID1Cleared 510(K)
- K870503HEARING AID, UNITRON MODEL UM601Cleared 510(K)
- K870435MODEL 350 WIRELESS CROS/CROS LOW OUTPUT HEAR. AID1Cleared 510(K)
- K870434MODEL 350 WIRELESS BICROS/MULTICROS HEARING AIDS1Cleared 510(K)
- K870350ESCORT EC CUSTOM IN-THE-EAR HEARING AID1Cleared 510(K)
- K870080MICRO-EAR FULL-CONCHA IN-THE-EAR HEARING AID1Cleared 510(K)
- K870081MICRO-EAR LOW-PROFILE IN-THE-EAR HEARING AID1Cleared 510(K)
- K870079MICRO-EAR CANAL IN-THE-EAR HEARING AID1Cleared 510(K)
- K864672PHONIC EAR MODELS PE 811CS AND PE 811CST1Cleared 510(K)
- K864277UNIMAX ITE & ULTRAMAX-CCR CUSTOM CANAL INSTRUMENTS1Cleared 510(K)
- K864823BEHIND THE EAR HEARING AIDS, BERNAFON COLIBRI, C11Cleared 510(K)
- K864028MODEL AQ8181 CUSTOM-CANAL-IN-THE EAR HEARING AID1Cleared 510(K)
- K864031MODEL AK 8184 CUSTOM-LOW-PROFILE HEARING AID1Cleared 510(K)
- K864030MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AID1Cleared 510(K)
- K864029AY8182 CUSTOM-SEMI CANAL-IN-THE-EAR HEARING AID1Cleared 510(K)
- K863975CUSTOM IN-THE-EAR1Cleared 510(K)
- K864180INTEGRA, CUSTOM IN-THE-EAR HEARING AID1Cleared 510(K)
- K864097WIDEX HEARING AID MODEL ES21Cleared 510(K)
- K863225UNITRON MODEL UL21 HEARING AID1Cleared 510(K)
- K862981OTICON I31 INITIALES HEARING AID1Cleared 510(K)
- K863787PA EQUALIZER1Cleared 510(K)
- K862980OTICON I31 CITE HEARING AID1Cleared 510(K)
- K862623I81 INITIALES1Cleared 510(K)
- K862754CUSTOM IN-THE-EAR AND CANAL HEARING AID1Cleared 510(K)
- K862622I22 CITE1Cleared 510(K)
- K862760HEARING AID, UNITRON MODEL UF111Cleared 510(K)
- K862670RIONET HEARING AID HB-35PT1Cleared 510(K)
- K862229PHONIC EAR PE 602 PPCS1Cleared 510(K)
- K862169ALPHA ALL-IN-THE-EAR HEARING AID1Cleared 510(K)
- K862545HEARING AID (ALL-IN-EAR)1Cleared 510(K)
- K862222INEARSET IES HEARING AID1Cleared 510(K)
- K862095MODEL CA, HEARING AID1Cleared 510(K)
- K862104MODEL UC SPECTRUM IN-THE-CANAL HEARING AID1Cleared 510(K)
- K862103MODEL UC IN-THE-CANAL HEARING AID1Cleared 510(K)
- K862102MODEL KM IN-THE-CANAL HEARING AID1Cleared 510(K)
- K862101MODEL UM IN-THE-CANAL HEARING AID1Cleared 510(K)
- K862100MODEL ED BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K862099DAHLBERG MODEL EE BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K862036MODEL HP HEARING AID1Cleared 510(K)
- K862050LIFESOUND CUSTOM ITE1Cleared 510(K)
- K861939MODEL PC HEARING AID1Cleared 510(K)
- K861532RX-33S INTRA MINI CANAL MODULE1Cleared 510(K)
- K861597BEHING-THE-EAR HEARING AID SERIES SP1Cleared 510(K)
- K861728RIONET HEARING AID1Cleared 510(K)
- K861492HEARING AID (ALL IN THE EAR)1Cleared 510(K)
- K854637LEE ELECTRONICS PAL1Cleared 510(K)
- K861254MODEL ST HEARING AID1Cleared 510(K)
- K860170VOROBA TECHNOLOGIES, ASSOC. QUANTUM HEARING AID1Cleared 510(K)
- K854311EARLENS1Cleared 510(K)
- K860759CHARISMA HEARING AID1Cleared 510(K)
- K860670DAHLBERG MODEL UT IN-THE-EAR HEARING AID1Cleared 510(K)
- K860671DAHLBERG MODEL EF BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K854124CRAIGWELL AID HA3001Cleared 510(K)
- K860512TELESTAR I, HEARING AID1Cleared 510(K)
- K860035MODEL 353C HEARING AID1Cleared 510(K)
- K860244A & M 150 PP (HEARING AID)1Cleared 510(K)
- K860191PA PRESIDENTIAL II - HEARING AID1Cleared 510(K)
- K860190A & M DISCREET - HEARING AID1Cleared 510(K)
- K860007AM 12, HEARING AID1Cleared 510(K)
- K860008AM 31, HEARING AID1Cleared 510(K)
- K855240BEHIND THE EAR HEARING AIDS MODEL1Cleared 510(K)
- K854834DAHLBERG MODEL KC IN-THE-EAR HEARING AID1Cleared 510(K)
- K854438THE ANSWER HEARING AID1Cleared 510(K)
- K854742OTICON, CITEC CUSTOM MADE HEARING AID CANAL TYPE1Cleared 510(K)
- K854315HEARTECH MODEL IN TECH1Cleared 510(K)
- K854001CERTI-FORM1Cleared 510(K)
- K853967HI-TECH LAB MODEL CONCHA ALL IN EAR1Cleared 510(K)
- K852656MODEL M HEARING AID1Cleared 510(K)
- K853895AUDTEX 851Cleared 510(K)
- K853942INT'L MODEL XE BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K853941INT'L MODEL XG BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K853793WIDEX MODEL M11Cleared 510(K)
- K853381OE SERIES OF BEHIND-THE-EAR HEARING AIDS1Cleared 510(K)
- K853781UNITRON MODEL UM60-PP1Cleared 510(K)
- K853780UNITRON MODEL UM60-D1Cleared 510(K)
- K852244HEARING AID(ALL IN EAR)1Cleared 510(K)
- K853605PERSONAL AMPLIFIER SLIMLINE III1Cleared 510(K)
- K853172INTERNATIONAL MODEL SC CANAL IN THE EAR HEARING AI1Cleared 510(K)
- K853170INTERNATIONAL MODEL SC CUSTOM IN THE EAR HEARG AID1Cleared 510(K)
- K853171INTERNATIONAL MODEL SC SEMICANAL IN THE EAR HEAR A1Cleared 510(K)
- K853636RIONET HEARING AID HI-061Cleared 510(K)
- K853637RIONET HEARING AID HI-071Cleared 510(K)
- K853638RIONET HEARING AID1Cleared 510(K)
- K853606PERSONAL AMPLIFIER COMMUNICATOR PREMIUM1Cleared 510(K)
- K853323DAHLBERG EA BEHING-THE-EAR HEARING AID1Cleared 510(K)
- K853324DAHLBERG EB BEHING-THE-EAR HEARING AID1Cleared 510(K)
- K853325DAHLBERG EC BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K853264HEARING AID MODEL 337D1Cleared 510(K)
- K853220HEARTECH MODEL ILLUSION1Cleared 510(K)
- K853219HEARTECH MODEL CH1Cleared 510(K)
- K853218HEARTECH MODEL(HTC) (HERITAGE)1Cleared 510(K)
- K853173INTERNATION MODEL SS STOCK CANAL IN THE EAR H.A.1Cleared 510(K)
- K853108MODEL 372L HEARING AID1Cleared 510(K)
- K852486DAH/BERG MODEL HP BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K852453RIONET HEARING AID HB-69HT1Cleared 510(K)
- K852452RIONET HEARING AID HB-71P1Cleared 510(K)
- K852451RIONET HEARING AID HB-34HT1Cleared 510(K)
- K852098DAHLBERG MODEL US SPECTRUM IN-THE-EAR HEARING AID1Cleared 510(K)
- K852052HEARING AID(ALL IN THE EAR(ALL IN THE CANAL1Cleared 510(K)
- K852690HEARING AID, UNITRON MODEL UM60-H1Cleared 510(K)
- K851866DAHLBERG MODEL DB BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K851867DAHLBERG MODEL DD BEHING-THE-EAR HEARING AID1Cleared 510(K)
- K851869DAHLBERG MODEL DC BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K851810MODEL DA BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K851868DAHLBERT MODEL DE BEHING-THE-EAR HEARING AID1Cleared 510(K)
- K851427HEARING AID(ALL IN THE EAR)1Cleared 510(K)
- K850980CRESTLINE CL IN-THE-EAR HEARING AID1Cleared 510(K)
- K851069BODY TYPE HEARING AID 107S1Cleared 510(K)
- K850914HEARING AID, UNITRON MODEL UC1Cleared 510(K)
- K851970QUALITONE STOCK CANAL AID1Cleared 510(K)
- K850981CRESTLINE CB BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K851547BEHIND THE EAR HEARING AID MODEL BERNAFON T-821Cleared 510(K)
- K851429EARETTE HEARING AID(BEHIND THE EAR OTICON E35F1Cleared 510(K)
- K851430EARETTE HEARING AID(BEHIND THE EAR OTICON E37F1Cleared 510(K)
- K850188BOSCH IN THE EAR HEARING AID SUPERSTAR1Cleared 510(K)
- K844862POST-AURICULAR HEARING AID MODEL PE 600PPCH1Cleared 510(K)
- K844863POST-SURICULAR HEARING AID PE 600CD1Cleared 510(K)
- K844859POST-AURICULAR HEARING AID MODEL PE 600 PPC1Cleared 510(K)
- K844860POST-AURICULAR HEARING AID MODEL PE 600CHD1Cleared 510(K)
- K844861POST-AURICULAR HEARING AID MODEL PE 600PPCL1Cleared 510(K)
- K850763EARETTE HEARING AID OTICON E32U1Cleared 510(K)
- K850762EARETTE HEARING AID OTICON MODEL E32S1Cleared 510(K)
- K850243HEARING AID 3651Cleared 510(K)
- K850189BOSCH STAR 66PP-S HEARING AID1Cleared 510(K)
- K850187BOSCH STARR 66PP -HEARING AIDS1Cleared 510(K)
- K850185BODY HEARING AIDS MT 80 SP1Cleared 510(K)
- K850190STAR 66F-AGC-I HEARING AID1Cleared 510(K)
- K850123IN-TH-EAR HEARING AID1Cleared 510(K)
- K844093JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR1Cleared 510(K)
- K844985IN THE EAR MODEL X-ITE 841Cleared 510(K)
- K844728ADVANCED HEARING INSTRUMENTS - HEARING AIDS1Cleared 510(K)
- K843484MECON X (TEN)1Cleared 510(K)
- K843246HEARING AID, UNITRON UE12-PPL1Cleared 510(K)
- K843245HEARING AID, UNITRON UE12-PP1Cleared 510(K)
- K844648MODEL 363C HEARING AID1Cleared 510(K)
- K844621BEHIND THE EAR HEARING AID BERNAFON T-88P1Cleared 510(K)
- K844425BEHIND THE EAR HEARING AIDS BERNAFON X-131Cleared 510(K)
- K843789ULTRA & ULTRA MINATURE1Cleared 510(K)
- K843574HEARING AID - ALL IN THE EAR1Cleared 510(K)
- K844059RIONET HEARING AID HB-34AS1Cleared 510(K)
- K843068HEARING AIDS 372 & 372 AI1Cleared 510(K)
- K843980PERSONAL AMPLIFIER SILENCER1Cleared 510(K)
- K844000RIONET HEARING AID HB-731Cleared 510(K)
- K843791BEHIND-THE-EAR 123 VTH1Cleared 510(K)
- K842832A.S.P.C./CLEARSOUND1Cleared 510(K)
- K843921IN THE CANAL HEARING AID RC, REDICANAL1Cleared 510(K)
- K843144K-BASS LO FREQUENCY HEARING AID1Cleared 510(K)
- K841934RADIOEAR M430 PP1Cleared 510(K)
- K843067TCA HEARING AID1Cleared 510(K)
- K842980IN-THE-EAR-CANAL HEARING AID1Cleared 510(K)
- K842546CUSTOM CANAL HEARING AID X-CITE 841Cleared 510(K)
- K842875RIONET HEARING AID HB-351Cleared 510(K)
- K842434BEHING THE EAR HEARING AID T-981Cleared 510(K)
- K842074EARETTE HEARING AID OTICON E30V1Cleared 510(K)
- K842073EARETTE HEARING AID OTICON E31V1Cleared 510(K)
- K841935RIONET HEARING AID HI-031Cleared 510(K)
- K841933RADIOEAR M420H1Cleared 510(K)
- K840893CONFERETTE C21Cleared 510(K)
- K841436OTICON E28A1Cleared 510(K)
- K841475HEARING AID MODEL M4001Cleared 510(K)
- K841473HEARING AID MODEL 440PPC1Cleared 510(K)
- K841474HEARING AID MODEL P5001Cleared 510(K)
- K833486IN-THE-EAR HEARING AID MODEL1Cleared 510(K)
- K840906HEARING AID AUDIO-STARR A1Cleared 510(K)
- K840891IN-THE-EAR HEARING AID RX10 & 201Cleared 510(K)
- K840728HEARING AIDS IN-THE-EAR1Cleared 510(K)
- K840298MCA IN THE EAR CUSTOM HEARING AID1Cleared 510(K)
- K840165CANAL AID1Cleared 510(K)
- K841012RIONET HEARING AID HB-71M1Cleared 510(K)
- K840871BEHIND-THE-EAR HEARING AID 20001Cleared 510(K)
- K840842HEARING AID UNITRON UE81Cleared 510(K)
- K840825SERIES MR IN-THE-EAR CUSTOM HEARING AID1Cleared 510(K)
- K840559IN-THE-EAR HEARING AID1Cleared 510(K)
- K840480BEHIND THE EAR HEARING AID T-971Cleared 510(K)
- K840479BEHING-THE-EAR HEARING AID T-85D1Cleared 510(K)
- K833773CANAL HEARING AID1Cleared 510(K)
- K840359POST-AURICULAR HEARING AID1Cleared 510(K)
- K834523MODEL M410D HEARING AID1Cleared 510(K)
- K833926HEARING AID1Cleared 510(K)
- K833803OTICON, E26P1Cleared 510(K)
- K833775BEHIND-THE-EAR HEARING AIDS T-87 &1Cleared 510(K)
- K833333IN THE EAR HEARING AID OMNI 1001Cleared 510(K)
- K833152METAVOX MV-1000 HEARING AID1Cleared 510(K)
- K833614HEARING AID, UNITRON UT11Cleared 510(K)
- K833615HEARING AID UNITRON UI31Cleared 510(K)
- K832633INNOVATIVE HEARING CORP. #IHC 10001Cleared 510(K)
- K832168PERSONAL AMPLIFIER1Cleared 510(K)
- K833510PANASONIC WH-50 HEARING AID1Cleared 510(K)
- K833451TEL-STAR NUWAY & GENERIC E ASP-BP1Cleared 510(K)
- K833334BEHIND THE EAR ASP-BB1Cleared 510(K)
- K833134RIONET HEARING AID HB-3451Cleared 510(K)
- K833073DAHLBERG #USS IN THE EAR HEARING AID1Cleared 510(K)
- K832751BEHIND-THE-EAR SERIES 1251Cleared 510(K)
- K832701HSI ELITE #EC CUSTOM CANAL HEAR-AID1Cleared 510(K)
- K832376WIDEX HEARING AID MODEL L11Cleared 510(K)
- K832326BEHIND-THE-EAR #123 AGCI1Cleared 510(K)
- K832180REXTON RX10, RX20-30 & 401Cleared 510(K)
- K831883HEARING AID UNITRON #UE8-D1Cleared 510(K)
- K831129HEARCO C1Cleared 510(K)
- K832081PHONIC EAR PE 845PPC-D1Cleared 510(K)
- K832129HEARING AID G3H & G3T1Cleared 510(K)
- K830790PERSONAL AMPLIFIER MODULE1Cleared 510(K)
- K831721RIONET HEARING AID -AND/OR RION1Cleared 510(K)
- K830960CUSTOM IN-THE-EAR HEARING AID1Cleared 510(K)
- K831217MODEL BERNAFON T-861Cleared 510(K)
- K831197MODEL 343D HEARING AID1Cleared 510(K)
- K830465WIDEX HEARING AID #G2H & G2T1Cleared 510(K)
- K823588PERSONAL ROMEAR1Cleared 510(K)
- K823788MECON I1Cleared 510(K)
- K830236RIONET HEARING AID1Cleared 510(K)
- K830436OTICON, E-27P1Cleared 510(K)
- K830435OTICON, E25P1Cleared 510(K)
- K830459BEHIND THE EAR HEARING AID OMNI #OS1Cleared 510(K)
- K830402HEARING AID, #UE7-D1Cleared 510(K)
- K830303800 BLUE1Cleared 510(K)
- K830098PHONIC EAR1Cleared 510(K)
- K823067MODEL F1 HEARING AID1Cleared 510(K)
- K823847RIONET HEARING AID HB-69CI1Cleared 510(K)
- K823803RIONET HEARING AID HB-32P1Cleared 510(K)
- K823089RCI EARMATE1Cleared 510(K)
- K823244TECH. CLARATRON & INDUSTRIAL AMPLIFIER1Cleared 510(K)
- K823178TEL-STAR NU-WAY & GENERIC E1Cleared 510(K)
- K823073101M IN-THE-EAR1Cleared 510(K)
- K823669HEARING AID UNITRON #UE4-H1Cleared 510(K)
- K823531BEHIND-THE-EAR HEARING AID #80031Cleared 510(K)
- K823383HEARING AID HB-33 RIONET1Cleared 510(K)
- K823384HEARING AID HB-72 RIONET1Cleared 510(K)
- K823468MODEL H 37E1Cleared 510(K)
- K823460MODELS G6H, G6T, G1H & G1T1Cleared 510(K)
- K823431HEARING AID #G6H & G6T1Cleared 510(K)
- K823366HEARING AID UE-10-H1Cleared 510(K)
- K823285MODEL WHO1 HEARING AID1Cleared 510(K)
- K823365HEARING AID UE-101Cleared 510(K)
- K822805HEARING AID, UNITRON MODEL UE71Cleared 510(K)
- K822779PHONIC EAR-PE 845-PPC1Cleared 510(K)
- K822579BOSCH STAR 66F-SP HEARING AID1Cleared 510(K)
- K822655BEHIND-THE-EAR MODEL 115 V AGC O W1Cleared 510(K)
- K822619BEHIND-THE-EAR MODEL 115PPPCW1Cleared 510(K)
- K822506HEARING AID, UNITRON UE3-D/DN1Cleared 510(K)
- K822387BEHIND-THE-EAR MODEL SERIES 1231Cleared 510(K)
- K821987EARETTE HEARING AID OPTICON MODEL E28P1Cleared 510(K)
- K821991DANAVOS CUSTOM EAR1Cleared 510(K)
- K822163ENT RETRACTORS1Cleared 510(K)
- K821972HEARING AID VARIOUS MODELS1Cleared 510(K)
- K821900HEARING AID, UNITRON MODEL UE51Cleared 510(K)
- K821899HEARING AID, UNITRON MODELS UE3/3-N1Cleared 510(K)
- K821760SERIES M PUSH-PULL INPUT COMPRESSION1Cleared 510(K)
- K821550MODEL AH BEHING-THE-EAR-HEARING AID1Cleared 510(K)
- K821447MODEL BERUAFON T85 & T951Cleared 510(K)
- K821390CUSTOM, IN-THE-EAR HEARING AID1Cleared 510(K)
- K821325OTICON1Cleared 510(K)
- K821165SONIC MODEL 8711 HEARING AID1Cleared 510(K)
- K821132MODEL 28C HEAPING AID1Cleared 510(K)
- K821042MODEL IM91Cleared 510(K)
- K820993AUDIO-ADI, AA SERIES1Cleared 510(K)
- K820833AUDICRAFT VIP HEARING AID1Cleared 510(K)
- K820656RIONET HEARING AID HA-571Cleared 510(K)
- K820185RELINER FOR HEARING AID EARMOLDS1Cleared 510(K)
- K820488CHAMPION - HEARING AID1Cleared 510(K)
- K820445HEARING AID1Cleared 510(K)
- K820425OTOMET MODEL M-9 HEARING INSTRUMENT1Cleared 510(K)
- K820398DAHLBERG HEARING AID MODEL AL1Cleared 510(K)
- K820350RIONET HEARING AID HB-71S1Cleared 510(K)
- K820349RIONET HEARING AID HB-71H1Cleared 510(K)
- K820348RIONET HEARING AID HB-69AS1Cleared 510(K)
- K820172PHONIC EAR MODEL PE 810S1Cleared 510(K)
- K820148MODEL 343 HEARING AID1Cleared 510(K)
- K820041BOSCH TOP STAR III1Cleared 510(K)
- K813329POST-AURICULAR HEARING AID MODEL P-1011Cleared 510(K)
- K813330POST-AURICULAR HEARING AID MODEL S-1011Cleared 510(K)
- K813583PHONIC EAR MODEL PE805CD1Cleared 510(K)
- K813546RIONET HEARING AID HI-621Cleared 510(K)
- K813344POST-AURICULAR HEARING AID MODEL ASP-1031Cleared 510(K)
- K813316CUSTOM-IN-THE-EAR HEARING AID1Cleared 510(K)
- K813206HEARING AID CUSTOM ITE1Cleared 510(K)
- K813229HEARING AID MODEL UE9-R1Cleared 510(K)
- K813249HELP-MATE1Cleared 510(K)
- K812938IN-THE-EAR MODEL 8211Cleared 510(K)
- K812939IN-THE-EAR MODEL 101M1Cleared 510(K)
- K812937BEHIND-THE-EAR MODEL 1151Cleared 510(K)
- K812578ELEGANCE1Cleared 510(K)
- K811988EAGLE I HEARING AID1Cleared 510(K)
- K811719CUSTOM IN-THE-EAR HEARING AID1Cleared 510(K)
- K811751FINETONE MODEL VI HEARING AID1Cleared 510(K)
- K811578DAHLBERG MODEL AP HEARING AID1Cleared 510(K)
- K811031TELESONIC & ARCON1Cleared 510(K)
- K811531RIONET HEARING AID HB-691Cleared 510(K)
- K811530RIONET HEARING AID HB 69 T1Cleared 510(K)
- K811529RIONET HEARING AID HB-69S1Cleared 510(K)
- K811522RE-HP SERIES HEARING AIDS1Cleared 510(K)
- K811344BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K811286HEARING AID MODEL E1-PL1Cleared 510(K)
- K811285HEARING AID MODEL E1-P1Cleared 510(K)
- K811158OMNI1Cleared 510(K)
- K811226DAHLBERG MODEL AM1Cleared 510(K)
- K811174HEARING AID, UNITRON MODEL C5-H1Cleared 510(K)
- K810986EARETTE HEARING AID OTICON #E25F1Cleared 510(K)
- K810987EARETTE HEARING AID OTICON #E27F1Cleared 510(K)
- K810577POWER SONIC1Cleared 510(K)
- K810347BOSCH STAR 66F SUPER EARLEVEL AID1Cleared 510(K)
- K810610EARETTE HEARING AID OTICON #E271Cleared 510(K)
- K810576EARETTE HEARING AID(BEHING THE EAR)1Cleared 510(K)
- K810389EARETTE HEARING AID SEARS MODEL 80531Cleared 510(K)
- K810030POST-AURICULAR HEARING AID (#PE830)1Cleared 510(K)
- K802859BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K802382SONIC EAR1Cleared 510(K)
- K802597TELESONIC ARCON & SOUNDEX ASP 1011Cleared 510(K)
- K802596TELESONIC, ARCON & SOUNDEX ASP 1021Cleared 510(K)
- K802510DAHLBERG HEARING AID MODEL AI1Cleared 510(K)
- K802306WIDEX HEARING AID #'S A18+T & A18+H1Cleared 510(K)
- K802324E1 SERIES HEARING AID1Cleared 510(K)
- K802307WIDEX HEARING AID #'S A12+T & A12+H1Cleared 510(K)
- K802053RIONET HEARING AID HB-69C1Cleared 510(K)
- K801958RIONET HEARING AID HB-70H1Cleared 510(K)
- K801692RIONET HEARING AID AND/OR RION #HB-701Cleared 510(K)
- K801556RIONET HEARING AID HB-661Cleared 510(K)
- K801448OTICON MODEL E17P EARETTE HEARING AID1Cleared 510(K)
- K801367MODEL 336B HEARING AID1Cleared 510(K)
- K801230HEARING AID, UNITRON MODEL C4-551Cleared 510(K)
- K801062BEHIND-THE-EAR HEARING AID SERIES G1Cleared 510(K)
- K800940AUDIONICS PB MAX HEARING AID1Cleared 510(K)
- K800779OMNITON MT80-A BODY HEARING AID1Cleared 510(K)
- K801114DAHLBERG HEARING AID MODEL MEH1Cleared 510(K)
- K801115DAHLBERG HEARING AID MODEL MEL1Cleared 510(K)
- K801067TELESONIC, GENERIC & SOUNDEX C-1021Cleared 510(K)
- K801066TELESONIC, SOUNDEX & GENERIC V-1011Cleared 510(K)
- K801023ASL CUSTOM IN-THE-EAR HEARING AID #L1Cleared 510(K)
- K801003OTICON EARETTE HEARING AID #E17CF1Cleared 510(K)
- K801002OTICON EARETTE HEARING AID #E17 HC1Cleared 510(K)
- K800945RADIOEAR MODEL REI HEARING AID1Cleared 510(K)
- K800567RADIOEAR MODEL RM-L & RM-C HEARING AID1Cleared 510(K)
- K800739RIONET &/OR RION HEARING AID MODEL HA-821Cleared 510(K)
- K800738RIONET &/OR RION HEARING AID MOD. HB-67S1Cleared 510(K)
- K800447SEARS ALL-IN-THE-EAR HEARING AID #8149HF1Cleared 510(K)
- K800446SEARS ALL-IN-THE-EAR HEARING AID #81491Cleared 510(K)
- K800571DAHLBERG #AZ BEHIND THE EAR HEARING AID1Cleared 510(K)
- K800244BEHIND EAR HEARING AID MODEL E24C11Cleared 510(K)
- K800345MODEL 795U BEHIND THE EAR HEARING AID1Cleared 510(K)
- K800332RADIOEAR MODEL 2080 (HEARING AID)1Cleared 510(K)
- K800181DAHLBERG # AF BEHING THE EAR HEARING/AID1Cleared 510(K)
- K800340PHONIC EAR, MODEL 841L1Cleared 510(K)
- K800316OTICON MODEL E19VF EARETTE HEARING AID1Cleared 510(K)
- K800283OTICON MODEL E17VF EARETTE HEARING AID1Cleared 510(K)
- K800269AUDIONICS PB MAX HEARING AID1Cleared 510(K)
- K800113SEARS BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K800105TELESONIC (HEARING AID)1Cleared 510(K)
- K800012RIONET HEARING AID HA-611Cleared 510(K)
- K800011RIONET HEARING AID HE-711Cleared 510(K)
- K792644TELESONIC V-1011Cleared 510(K)
- K792643HEARING AID, MODELS DRI-35/DL1-351Cleared 510(K)
- K792389WIDEX HEARING AID MODEL S101Cleared 510(K)
- K792567WIDEX HEARING AID MODEL 8201Cleared 510(K)
- K792464MODEL 341H (HEARING AID)1Cleared 510(K)
- K792463MODEL 339 TELECROS WIRELESS CROS1Cleared 510(K)
- K792462MODEL 339 TELECROS WIRELESS BICROS1Cleared 510(K)
- K792506RIONET HEARING AID HB-68L1Cleared 510(K)
- K792505RIONET HEARING AID HB-32T1Cleared 510(K)
- K792334BEHINDTHEEAR HEAR. AID MOD. 793U,M,UH,MH1Cleared 510(K)
- K792236HEARING AID, UNITRON MODEL 905H1Cleared 510(K)
- K792237HEARING AID, UNITRON MODEL 905W1Cleared 510(K)
- K792278DAHLBERG MODEL AE HIGH FREQUENCY / AID1Cleared 510(K)
- K792198SERIES S (BEHIND-THE-EAR-HEARING AID)1Cleared 510(K)
- K791881RIONET HEARING AID HB-65T1Cleared 510(K)
- K791739RIONET HEARING AID MODEL HA-551Cleared 510(K)
- K791878RIONET HEARING AID HB-64C1Cleared 510(K)
- K791880RIONET HEARING AID HB-64T1Cleared 510(K)
- K791745MODEL H44-80 BEHIND THE EAR HEARING1Cleared 510(K)
- K791882RIONET HEARING AID HB-67T1Cleared 510(K)
- K791884RIONET HEARING AID HI-601Cleared 510(K)
- K791877RIONET HEARING AID HB-32H1Cleared 510(K)
- K791876RIONET HEARING AID HB-321Cleared 510(K)
- K791879RIONET HEARING AID HB-64S1Cleared 510(K)
- K791601MODEL 336A HEARING AIDS1Cleared 510(K)
- K791600MODEL 33A HEARING AIDS1Cleared 510(K)
- K791599MODEL 33DA HEARING AIDS1Cleared 510(K)
- K791310DAHLBERG HEARING AID MODEL GC1Cleared 510(K)
- K791506MODEL 3441Cleared 510(K)
- K791311DAHLBERG HEARING AID MODEL UN1Cleared 510(K)
- K791356EARETTE HEARING AID1Cleared 510(K)
- K791203MODEL SE-1 EYEGLASS HEARING AID1Cleared 510(K)
- K791126MODEL CE-DM-II HEARING INSTRUMENT1Cleared 510(K)
- K790870MODEL H63, BEHIND-THE-EAR1Cleared 510(K)
- K790737HSI MODEL C. CUSTOM IN-THE-EAR HEAR/AID1Cleared 510(K)
- K790745_MODEL WC-1 BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K790726BEHIND-THE-EAR HEARING INSTRUMENT, H541Cleared 510(K)
- K790727BEHIND-THE-EAR, MODEL H37D1Cleared 510(K)
- K790700BEHIND-THE-EAR HEARING INSTRUMENT, H561Cleared 510(K)
- K790697MODEL H58-BEHIND-THE-EAR HEARING INSTR.1Cleared 510(K)
- K790651MODEL WC-3 HEARING AID1Cleared 510(K)
- K790539HEARING AID DANAVOX 775V1Cleared 510(K)
- K790515BEHIND-THE-EAR HEARING AID1Cleared 510(K)
- K790482MODEL 4107-2S, HEARING AID1Cleared 510(K)
- K790412MODEL 337E HEARING AID1Cleared 510(K)
- K790355MODEL 342D HEARING AIDS1Cleared 510(K)
- K790354MODEL 342 HEARING AIDS1Cleared 510(K)
- K790270HEARING AID MODEL 81431Cleared 510(K)
- K790301HEARING AID, OTICON I II H1Cleared 510(K)
- K790228EARETTE HEARING AID1Cleared 510(K)
- K790093MODULE PERSONAL EAR (SUPER)1Cleared 510(K)
- K790095MODULE PERSONAL EAR (DELUXE)1Cleared 510(K)
- K790094MODULE PERSONAL EAR (COMPRESSION)1Cleared 510(K)
- K782121HEARING AID, MODEL GB1Cleared 510(K)
- K782122HEARING AID, MODEL AA1Cleared 510(K)
- K782053HEARING AID, POST-AURICULAR1Cleared 510(K)
- K781881HEARING AID, MODEL 7811Cleared 510(K)
- K781663HEARING AID, ITE MODULAR MODEL I, II, V1Cleared 510(K)
- K781595BODY-WORN HEARING AID, MODEL 787PP1Cleared 510(K)
- K781596HEARING AID, MODEL 775 PP/AGC1Cleared 510(K)
- K781513HEARING AID, UNITRON MODEL 960PL1Cleared 510(K)
- K781502HEARING AID, UNITRON MODEL 761P1Cleared 510(K)
- K781458RADIOEAR RE SERIES HEARING AIDS1Cleared 510(K)
- K781434HEARING AID, UNITRON MODEL 9751Cleared 510(K)
- K781439HEARING AID, UNITRON MODEL 9581Cleared 510(K)
- K781212HEARING AID, MODEL 783DU1Cleared 510(K)
- K781094HEARING AID, EYEGLASS1Cleared 510(K)
- K781096HEARING AID, EYEGLASS, B-121Cleared 510(K)
- K781095HEARING AID, BEHIND THE EAR1Cleared 510(K)
- K781033HEARING AID1Cleared 510(K)
- K780915780 SE (BEHIND THE EAR)1Cleared 510(K)
- K780922UM VII (BEHIND THE EAR)1Cleared 510(K)
- K780921MM-CE DM (BEHIND THE EAR)1Cleared 510(K)
- K780920MM-CE 11 (BEHIND THE EAR)1Cleared 510(K)
- K780919M25 PP (BEHIND THE EAR)1Cleared 510(K)
- K780918PRIMO CEDM (BEHIND THE EAR)1Cleared 510(K)
- K780917PRIMO CE (BEHIND THE EAR)1Cleared 510(K)
- K780916780 UE (BEHIND THE EAR)1Cleared 510(K)
- K780914PM 25 PP (BODY AID)1Cleared 510(K)
- K780820HEARING AID MODEL 81481Cleared 510(K)
- K780822HEARING AID MODEL 8160U1Cleared 510(K)
- K780821HEARING AID MODEL 8160H1Cleared 510(K)
- K780694HEARING AID BATTERY CHARGER1Cleared 510(K)
- K780699EARETTE HEARING AID1Cleared 510(K)
- K780669HEATING AIDS-MODEL C78A & C78B1Cleared 510(K)
- K780667HEARING AID-MODEL 20101Cleared 510(K)
- K780654HEARING AID, EARETTE1Cleared 510(K)
- K780459CLEARTONE MODEL-1 & 2 HEARING AIDS1Cleared 510(K)
- K780363PHONIC EAR1Cleared 510(K)
- K780309IN-THE-EAR HEARING AID, MODEL CE-31Cleared 510(K)
- K780197HEARING AID, BODY WORN1Cleared 510(K)
- K780241COMPRESSION MULTISONIC1Cleared 510(K)
- K780067HEARING AID, BEHIND-THE-EAR1Cleared 510(K)
- K772201HEARING AID, BODY TYPE, MODEL H1Cleared 510(K)
- K772100HEARING AID-MODEL CE-21Cleared 510(K)
- K772101HEARING AID-MODEL PE-11Cleared 510(K)
- K771762MODULAR HEARING DEVICE, MODEL S2911Cleared 510(K)
- K771607HEARING AID MODEL 7751Cleared 510(K)
- K771356POST-AURICULAR HEARING AID HC 8801Cleared 510(K)
- K771069MULTISONIC (SUPER) CODE TSM1Cleared 510(K)
- K771029MULTISONIC (DELUXE) CODE TDM1Cleared 510(K)
- K770960HEARING AID, SERIES R1Cleared 510(K)
- K770885HEARING AID, SERIES K-BEHIND-THE-EAR1Cleared 510(K)
- K770688HEARING AID MODEL F8H ANL F8T1Cleared 510(K)
- K770689HEARING AID MODEL A8H AND A8T1Cleared 510(K)
- K770373HEARING AID, MAICO DB-POWER1Cleared 510(K)
- K770360HEARING AID, MAICO DM MARK 1801Cleared 510(K)
- K770321PERCEPTOR1Cleared 510(K)
- K770309HEARING AID, DM IROS1Cleared 510(K)
- K770308HEARING AID, DM IROS DIRECTIONAL1Cleared 510(K)
- K761223WIDEX HEARING AID MODEL F81Cleared 510(K)
- K761216HEARING AIDS (MODEL E-552 S-712)1Cleared 510(K)
- K761103WIDEX HEARING AID MODEL F7H & F7T1Cleared 510(K)
- K760996HEARING AID (MODEL 695D, 905 & 960P)1Cleared 510(K)
- K760887COMPRESSION ADJUSTRETTE1Cleared 510(K)
- K760609EYEGLASS HEARING AID1Cleared 510(K)
- K760244RADIOEAR, PERSONAL1Cleared 510(K)
- K760215HEARING AID, S-522 FM1Cleared 510(K)
- ESELarynx, Artificial (Battery-Powered)1Product Code
- ESHPolymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane2Product Code
- ESXTack, Sacculotomy (Cody Tack)2Product Code
- ESZTube, Shunt, Endolymphatic2Product Code
- ETAReplacement, Ossicular Prosthesis, Total2Product Code
- ETBProsthesis, Partial Ossicular Replacement2Product Code
- ETCMold, Middle-Ear2Product Code
- ETDTube, Tympanostomy2Product Code
- ETWCalibrator, Hearing Aid / Earphone And Analysis Systems2Product Code
- EWLProsthesis, Laryngeal (Taub)2Product Code
- FWNProsthesis, Larynx (Stents And Keels)2Product Code
- JAZProsthesis, Facial, Mandibular Implant2Product Code
- JOFPolymer, Ent Synthetic, Porous Polyethylene2Product Code
- JXSBlock, Cutting, Ent, Sterile1Product Code
- JXTCrimper, Wire, Ent, Sterile1Product Code
- JXWDie, Wire Bending, Ent, Sterile1Product Code
- JXXForceps, Wire Closure, Ent, Sterile1Product Code
- JXYJig, Piston Cutting, Ent, Sterile1Product Code
- JXZPunch, Gelfoam, Sterile1Product Code
- JYAScissors, Wire Cutting, Ent, Sterile1Product Code
- JYBVise, Ossicular Finger, Sterile1Product Code
- KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)2Product Code
- KHLHearing Aid, Master2Product Code
- KLWMasker, Tinnitus2Product Code
- KLZTube, Shunt, Endolymphatic With Valve2Product Code
- KQLTube, Tympanostomy With Semi-Permeable Membrane2Product Code
- LBLTube, Tympanostomy, Porous Polyethylene2Product Code
- LBMPorous Polyethylene Ossicular Replacement2Product Code
- LBNReplacement, Total Ossicular, Prosthesis, Porous, Polyethylene2Product Code
- LBPReplacement, Ossicular (Stapes) Using Absorbable Gelatin Material2Product Code
- LDGKit, Earmold, Impression1Product Code
- LRBFace Plate Hearing Aid1Product Code
- LREInstrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile1Product Code
- LWFDilator, Nasal1Product Code
- LXBHearing Aid, Bone Conduction2Product Code
- LZIDevice, Assistive Listening2Product Code
- MAHHearing Aid, Bone Conduction, Implanted2Product Code
- MCKDevice, Voice Amplification2Product Code
- MIXSystem, Vocal Cord Medialization2Product Code
- NHBPolymer, Ear, Nose And Throat, Synthetic, Absorbable2Product Code
- NIXHearing Aid, Air Conduction, Transcutaneous System2Product Code
- NNNCrimper, Wire, Ent, Non-Sterile1Product Code
- NNOJig, Piston Cutting, Ent, Non-Sterile1Product Code
- NNPDie, Wire Bending, Ent, Non-Sterile1Product Code
- NNQForceps, Wire Closure, Ent, Non-Sterile1Product Code
- NNRBlock, Cutting, Ent, Non-Sterile1Product Code
- NNSInstrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile1Product Code
- NNTPunch, Gelfoam, Non-Sterile1Product Code
- NNUScissors, Wire Cutting, Ent, Non-Sterile1Product Code
- NNVVise, Ossicular Finger, Non-Sterile1Product Code
- OGSMyringotomy Procedure Kit2Product Code
- OSMHearing Aid, Air Conduction With Wireless Technology2Product Code
- PFOActive Implantable Bone Conduction Hearing System2Product Code
- PLKTympanic Membrane Direct Contact Hearing Aid2Product Code
- QDDSelf-Fitting Air-Conduction Hearing Aid2Product Code
- QUFHearing Aid, Air-Conduction, Over The Counter1Product Code
- QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter2Product Code
- QUHSelf-Fitting Air-Conduction Hearing Aid, Over The Counter2Product Code
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
OMNI 2000 SERIES ITE HEARING AID
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K934416
- 510(k) Type
- Traditional
- Applicant
- STARKEY LABORATORIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/29/1993
- Days to Decision
- 77 days
- Submission Type
- Summary