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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
EPF
Hearing Aid, Group And Auditory Trainer
2
Product Code
NEA
Cement, Ear, Nose And Throat
2
Product Code
ESD
Hearing Aid, Air Conduction
1
Product Code
K
23
2999
Lyric4 Hearing Aid
1
Cleared 510(K)
K
13
0790
LYRIC2
1
Cleared 510(K)
K
08
1136
LYRIC HEARING AID
1
Cleared 510(K)
K
02
1867
INSOUND XT SERIES HEARING AID
1
Cleared 510(K)
K
00
3558
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
1
Cleared 510(K)
K
98
4518
SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL
1
Cleared 510(K)
K
97
4751
TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC
1
Cleared 510(K)
K
97
4242
ARGOSY PROGRAMMABLE ONQUE
1
Cleared 510(K)
K
97
3880
SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM
1
Cleared 510(K)
K
97
4211
OPUS 2 - FULL CONCHA SERIES - ITE
1
Cleared 510(K)
K
97
4152
OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)
1
Cleared 510(K)
K
97
4069
OPUS 2 - CANAL SERIES (ITC)
1
Cleared 510(K)
K
97
4338
UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)
1
Cleared 510(K)
K
97
4339
UNITRON MODEL SOUND F/XD PROGRAMMABLE
1
Cleared 510(K)
K
97
4340
UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE
1
Cleared 510(K)
K
97
4257
RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)
1
Cleared 510(K)
K
97
4129
HI-69E, HI-69N, HI-69P
1
Cleared 510(K)
K
97
4081
RESOUND STEALTH CIC
1
Cleared 510(K)
K
97
3927
HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL
1
Cleared 510(K)
K
97
3861
FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48
1
Cleared 510(K)
K
97
3972
PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER)
1
Cleared 510(K)
K
97
3886
OTICON DIGISOUND COMPACT
1
Cleared 510(K)
K
97
3885
OTICON DIGISOUND ITE
1
Cleared 510(K)
K
97
3665
MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER
1
Cleared 510(K)
K
97
3846
AIR CONDUCTION HEARING AID
1
Cleared 510(K)
K
97
3948
DUALINE 100 BTE
1
Cleared 510(K)
K
97
3579
AM SERIES HEARING AID
1
Cleared 510(K)
K
97
3043
MODEL C-1 HEARING AID
1
Cleared 510(K)
K
97
2818
D72 DIGITAL
1
Cleared 510(K)
K
97
3376
LORI/LORI, LORI-S (LORI STOCK AID)
1
Cleared 510(K)
K
97
3266
Z DEQ-II
1
Cleared 510(K)
K
97
2776
DRY & STORE
1
Cleared 510(K)
K
97
2998
PRISMA
1
Cleared 510(K)
K
97
2039
NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC)
1
Cleared 510(K)
K
97
2106
PHONAK NOVO FORTE E3
1
Cleared 510(K)
K
97
2058
LORIPRO, LORIPRO II
1
Cleared 510(K)
K
97
1852
AIR CONDUCTION HAEARING AIDS
1
Cleared 510(K)
K
97
1845
HEARTLAND TECHNOLOGIES, ITE, ITC, CIC
1
Cleared 510(K)
K
97
1807
IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL
1
Cleared 510(K)
K
97
2755
V-12 LONG LIFE 675 HEARING AID
1
Cleared 510(K)
K
97
2105
PHONAK EPICA
1
Cleared 510(K)
K
97
2550
AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC
1
Cleared 510(K)
K
97
2552
AUDIFON H20 PC/AUDIFON H32 PP
1
Cleared 510(K)
K
97
2097
PHONAK MICROZOOM P 2
1
Cleared 510(K)
K
97
2373
OVATION HDP
1
Cleared 510(K)
K
97
2542
JAZZ PP AGC-O, JAZZ PP
1
Cleared 510(K)
K
97
2543
TWIST PPAGC-1, TWIST PP
1
Cleared 510(K)
K
97
2431
MERIDIAN DSP
1
Cleared 510(K)
K
97
2344
MIRACLE-EAR DIGITAL BTE
1
Cleared 510(K)
K
97
2346
MIRACLE-EAR ITE DIGITAL
1
Cleared 510(K)
K
97
2345
DAHLBERG/MIRACLE-EAR
1
Cleared 510(K)
K
97
1298
BETTER HEARING, INC. MODEL L-1 HEARING AID
1
Cleared 510(K)
K
97
1699
ARGOSY DYNAMEQ
1
Cleared 510(K)
K
97
1605
RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION
1
Cleared 510(K)
K
97
1296
TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05
1
Cleared 510(K)
K
97
1031
AUDALLION III HEARING SYSTEM
1
Cleared 510(K)
K
97
1032
DANAVOX MODELS 163/162 BTE
1
Cleared 510(K)
K
97
1399
AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC
1
Cleared 510(K)
K
97
1158
DUALINE 400 CIC
1
Cleared 510(K)
K
97
1804
PHILIPS S1694, S1695
1
Cleared 510(K)
K
97
1693
RIONET HB-79P
1
Cleared 510(K)
K
97
1535
WIDEX SENSO DIGITAL (MINI CANAL)
1
Cleared 510(K)
K
97
1299
SCIENTIFIC PLASTICS MODEL SP
1
Cleared 510(K)
K
97
0939
VISTA V-38 CIC
1
Cleared 510(K)
K
97
0880
POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN
1
Cleared 510(K)
K
97
0828
UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMER
1
Cleared 510(K)
K
97
0692
UNITRON MODEL SOUND F/X CIC
1
Cleared 510(K)
K
97
0952
PRECISE IMPRESSION KIT
1
Cleared 510(K)
K
97
0519
UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)
1
Cleared 510(K)
K
96
4898
IN THE EAR HEARING AID
1
Cleared 510(K)
K
97
0262
MULTI-CHANNEL COMPRESSION BTE (SD)
1
Cleared 510(K)
K
97
0215
AUDALLION II HEARING SYSTEM
1
Cleared 510(K)
K
97
0537
REXTON MODEL 48 AND 49PP
1
Cleared 510(K)
K
97
0904
WIDEX SENSO DIGITAL (CIC)
1
Cleared 510(K)
K
96
5254
WIDEX MODEL SENSO DIGITAL (C9)
1
Cleared 510(K)
K
97
0430
ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCI
1
Cleared 510(K)
K
97
0057
AHS OMEGA SP
1
Cleared 510(K)
K
96
4657
SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF
1
Cleared 510(K)
K
96
4245
PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS
1
Cleared 510(K)
K
96
4419
MIRACLE - EAR (ITE/ITC/CIC)
1
Cleared 510(K)
K
96
5049
DAHLBERG (A-554)
1
Cleared 510(K)
K
96
5057
AUDIOTONE (A554H)
1
Cleared 510(K)
K
96
5063
AUDIOTONE (A-552)
1
Cleared 510(K)
K
96
5218
SENSO DIGITAL (C18)
1
Cleared 510(K)
K
96
5088
M11 SERIES: M11, M11M
1
Cleared 510(K)
K
96
4680
COMFORTAID HEARING AID
1
Cleared 510(K)
K
96
4639
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II
1
Cleared 510(K)
K
96
4816
AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR
1
Cleared 510(K)
K
96
4669
MIRACLE-EAR OR AUDIOTONE
1
Cleared 510(K)
K
96
4794
DAHLBERG K-AMP BTE
1
Cleared 510(K)
K
96
4683
DIGIFOCUS ITE
1
Cleared 510(K)
K
96
4603
ARTICULAR HEARING AIDS
1
Cleared 510(K)
K
96
3877
AHS OMEGA CONCEPT
1
Cleared 510(K)
K
96
3878
AHS OMEGA HF
1
Cleared 510(K)
K
96
3958
IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT
1
Cleared 510(K)
K
96
4035
PHONAK MICROLINK, PERSONAL FM RECEIVER
1
Cleared 510(K)
K
96
4557
RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION
1
Cleared 510(K)
K
96
4530
DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT
1
Cleared 510(K)
K
96
4511
UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4)
1
Cleared 510(K)
K
96
4504
UNITRON MODEL ICON AOHPL +4
1
Cleared 510(K)
K
96
4502
UNITRON MODEL SOUND F/XP +4
1
Cleared 510(K)
K
96
4508
UNITRON MODEL ICON AOHP +4 (ICON AOHP +4)
1
Cleared 510(K)
K
96
4510
UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4)
1
Cleared 510(K)
K
96
4503
UNITRON MODEL SOUND F/X +4
1
Cleared 510(K)
K
96
4451
PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC
1
Cleared 510(K)
K
96
4244
STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS
1
Cleared 510(K)
K
96
4214
STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS
1
Cleared 510(K)
K
96
3875
AHS OMEGA K-AMP
1
Cleared 510(K)
K
96
3788
PRIMOFOCUS COMPACT
1
Cleared 510(K)
K
96
4180
AUDIO 'D' SOUND SELECTOR POWER (SSP)
1
Cleared 510(K)
K
96
3874
AHS OMEGA AGC
1
Cleared 510(K)
K
96
3881
AHS DELTA 22 T
1
Cleared 510(K)
K
96
3879
AHS DELTA 22
1
Cleared 510(K)
K
96
3876
AHS OMEGA PP
1
Cleared 510(K)
K
96
3873
AHS OMEGA DEQ
1
Cleared 510(K)
K
96
3745
MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR)
1
Cleared 510(K)
K
96
3915
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION
1
Cleared 510(K)
K
96
4115
RESOUND CC4 PERSONAL HEARING SYSTEM
1
Cleared 510(K)
K
96
3818
OVATION AGC-2
1
Cleared 510(K)
K
96
3822
OVATION AGC-3
1
Cleared 510(K)
K
96
3821
OVATION AGC-1
1
Cleared 510(K)
K
96
3820
OVATION LINEAR
1
Cleared 510(K)
K
96
3819
OVATION ASP
1
Cleared 510(K)
K
96
3604
DYNAMIC EQ II - 2 CHANNEL WIDE DYNAMIC RANGE COMPRESSION
1
Cleared 510(K)
K
96
3519
EUROLINE A-675 SERIS
1
Cleared 510(K)
K
96
3607
HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL
1
Cleared 510(K)
K
96
2388
IN THE EAR HEARING AID
1
Cleared 510(K)
K
96
3047
AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY)
1
Cleared 510(K)
K
96
2798
AUDIO 'D' K-AMP HR FULL SHELL AND CANAL HEARING AIDS
1
Cleared 510(K)
K
96
3122
UNITRON MODEL ICON KR
1
Cleared 510(K)
K
96
3154
RIONET HB-54AS
1
Cleared 510(K)
K
96
3153
RIONET HB-55S
1
Cleared 510(K)
K
96
3152
RIONET HB-55AS
1
Cleared 510(K)
K
96
2228
MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT
1
Cleared 510(K)
K
96
2847
MT10P, MT60-PP, MT60-AGC0, AND MT60
1
Cleared 510(K)
K
96
1770
PHILIPS 71 SERIES
1
Cleared 510(K)
K
96
2170
SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP
1
Cleared 510(K)
K
96
1907
RIONET HEARING AID HB53-K
1
Cleared 510(K)
K
96
1827
IN-THE-EAR
1
Cleared 510(K)
K
96
1729
ARGOSY PROGRAMMABLE
1
Cleared 510(K)
K
96
1653
PHONAK SONA P2
1
Cleared 510(K)
K
96
1622
PHONAK PICONET2 P2 AZ
1
Cleared 510(K)
K
96
1670
CLARITY
1
Cleared 510(K)
K
96
1308
AUDIO 'D' INTIMA CIC
1
Cleared 510(K)
K
96
1143
TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40
1
Cleared 510(K)
K
96
1082
TECHNA TONE
1
Cleared 510(K)
K
96
1059
DIGIFOCUS COMPACT
1
Cleared 510(K)
K
96
0741
COMFORTONE PHS
1
Cleared 510(K)
K
96
1084
AM 400
1
Cleared 510(K)
K
96
0680
RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES, EDR-EV, & EDR-P1
1
Cleared 510(K)
K
96
0684
HEARING AID - AIR CONDUCTION
1
Cleared 510(K)
K
96
0804
MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC
1
Cleared 510(K)
K
96
0410
PERFECT EAR PE/PE-AGC/PE-B/PE-PWR
1
Cleared 510(K)
K
96
0935
AUDIO 'D' 2N SERIES HEARING AIDS(FULL SHELL ITE,HALF SHELL ITE, MINI CANAL, CANAL)
1
Cleared 510(K)
K
96
0295
LONG LIFE RX-12
1
Cleared 510(K)
K
96
0052
RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241
1
Cleared 510(K)
K
96
0284
OTICON /PRIMOFOCUS (PF)
1
Cleared 510(K)
K
96
0155
UNITRON MODEL SOUND F/XP
1
Cleared 510(K)
K
96
0031
AUDIOFLEX 120
1
Cleared 510(K)
K
96
0494
EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS
1
Cleared 510(K)
K
95
5930
BELTONE COMPOSER 2000 BTE HP
1
Cleared 510(K)
K
95
5879
WIDEX MODEL SENSO DIGITAL (C16)
1
Cleared 510(K)
K
95
5702
SONATA U-01
1
Cleared 510(K)
K
95
5466
DYNAMEQ-II OPTION
1
Cleared 510(K)
K
95
5878
WIDEX MODEL SENSO DIGITAL (C8)
1
Cleared 510(K)
K
95
5867
RESOUND PERSONAL HEARING SYSTEM BT247
1
Cleared 510(K)
K
95
5692
FINETONE FSC,
1
Cleared 510(K)
K
95
5288
HEARING AID IMPRESSION MATERIAL
1
Cleared 510(K)
K
95
4119
MIRACLE EAR MIRAGE
1
Cleared 510(K)
K
95
4922
REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE INSTRUMENTS
1
Cleared 510(K)
K
95
5574
RESOUND PERSONAL HEARING SYSTEM BTP W/DAI
1
Cleared 510(K)
K
95
4941
MIRACLE EAR AND AUDIOTONE
1
Cleared 510(K)
K
95
5359
CYBER III OPTION UM, UC312, UC10, UCIC
1
Cleared 510(K)
K
95
4579
TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION
1
Cleared 510(K)
K
95
4936
BELTONE ULTIMA 80 OTOSONIC POWER PAS
1
Cleared 510(K)
K
95
4236
FACEPLATE (HEARING AID KIT)
1
Cleared 510(K)
K
95
4794
OTICON
1
Cleared 510(K)
K
95
3603
HEARING TODAY HEARING AID
1
Cleared 510(K)
K
95
4937
COAST HEARING CHS (CUSTOM HEARING SYSTEM)
1
Cleared 510(K)
K
95
4526
WIDEX SENSO DIGITAL (PX)
1
Cleared 510(K)
K
95
4528
MIRACLE - EAR MODEL PBP
1
Cleared 510(K)
K
95
4516
UNITRON MODEL SOUND F/X II
1
Cleared 510(K)
K
95
3727
UNITRON MODEL IKON AOHPD
1
Cleared 510(K)
K
95
3932
UNITRON MODEL SOUND F/XD
1
Cleared 510(K)
K
95
4430
UNITRON MODEL SOUND F/X
1
Cleared 510(K)
K
95
4067
3M MODEL 8295
1
Cleared 510(K)
K
95
4054
MAICO PRODIGY CIC SERIES
1
Cleared 510(K)
K
95
4038
K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT
1
Cleared 510(K)
K
95
3921
PHONAK 9900 CIC
1
Cleared 510(K)
K
95
3770
REXTON MINI-PRIMO PLUS, PP142, D.C .H.I. FAMILY
1
Cleared 510(K)
K
95
1002
AMENDMENTS TO MULTIFOCUS
1
Cleared 510(K)
K
95
3960
HEARING AID (ALL-IN-THE-EAR)
1
Cleared 510(K)
K
95
3729
K AMP FULL SHELL AND IN THE EAR
1
Cleared 510(K)
K
95
3728
RX12 LINEAR FULL SHELL AND IN THE CANAL
1
Cleared 510(K)
K
95
1712
HEARING AID (ALL-IN-THE-EAR)
1
Cleared 510(K)
K
95
3646
UNITRON MODEL IKON AOHPL
1
Cleared 510(K)
K
95
3631
SNIP INPUT COMPRESSION CLASS A
1
Cleared 510(K)
K
95
3543
3M MODEL 8200P MULTIPRO BTE
1
Cleared 510(K)
K
94
5439
PHONAK PICONET 232X-AZ HEARING INSTRUMENT
1
Cleared 510(K)
K
95
3050
Z33
1
Cleared 510(K)
K
95
3047
Z20
1
Cleared 510(K)
K
95
3053
AM 260 PP
1
Cleared 510(K)
K
95
3054
AM 260 OHM
1
Cleared 510(K)
K
95
3052
AM 260 K-AMP
1
Cleared 510(K)
K
95
3051
Z35
1
Cleared 510(K)
K
95
3049
Z24
1
Cleared 510(K)
K
95
3048
Z22
1
Cleared 510(K)
K
95
2986
SPI-SECRET PERSONAL INSTRUMENT CIC
1
Cleared 510(K)
K
95
2658
HEARING AID
1
Cleared 510(K)
K
95
3266
RESOUND PERSONAL HEARING SYSTEM BT250 MZ W/REMOTE CONTROL OPTION
1
Cleared 510(K)
K
95
2940
PERSONAL PROGRAMMER 2000
1
Cleared 510(K)
K
95
2821
MWCHAC 95 FS 12345
1
Cleared 510(K)
K
95
2820
MWCHAC 95 C 12345
1
Cleared 510(K)
K
95
3038
DYNAMIC EQ/CLASS D
1
Cleared 510(K)
K
95
3036
DB PUSH-PULL HEARING AID
1
Cleared 510(K)
K
95
3037
CUSTOM CANAL & FULL CONCHA INSTR (CLASS D CIR OPT)
1
Cleared 510(K)
K
95
1642
GOLD CD ULTRA MINI CANAL - MODULE
1
Cleared 510(K)
K
95
2452
OUTPUT COMPRESSION LIMITER WITH ACTIVE TONE CONTROL
1
Cleared 510(K)
K
95
2451
CLASS D LINEAR WITH ACTIVE TONE CONTROL
1
Cleared 510(K)
K
95
2450
WIDE DYNAMIC RANGE COMPRESSION WITH ACTIVE TONE CONTROL
1
Cleared 510(K)
K
95
2711
LORI-A
1
Cleared 510(K)
K
95
1828
FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT
1
Cleared 510(K)
K
95
1587
BELTONE PETITE PLUS BELTONE PETITE PLUS CLEARVIOCE K
1
Cleared 510(K)
K
94
6232
ACURA-EX
1
Cleared 510(K)
K
95
2097
OTOSONIC (OSI) CF 10-K, 10-D
1
Cleared 510(K)
K
95
0868
BELTONE COMPOSER 2000
1
Cleared 510(K)
K
95
2454
EXPANDER WITH ACTIVE TONE CONTROL
1
Cleared 510(K)
K
95
2453
INPUT COMPRSSION LIMITER WITH ACTIVE TONE CONTROL
1
Cleared 510(K)
K
95
2455
IMPROVED MANHATTAN II
1
Cleared 510(K)
K
95
2229
WIDEX MODEL LOGO 32 (L32)
1
Cleared 510(K)
K
95
2263
PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT
1
Cleared 510(K)
K
95
2228
SONAR CIC COMPLETELY IN-THE-CANAL HEARING DEVICE
1
Cleared 510(K)
K
95
1677
RIONET HEARING AID HM-02
1
Cleared 510(K)
K
95
1896
INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT
1
Cleared 510(K)
K
95
0963
AUDIOTECH MODEL SPI
1
Cleared 510(K)
K
94
3808
RIONET HM-02
1
Cleared 510(K)
K
94
3961
THE MODEL ACAPPELLA IN THE EAR HEARING AID
1
Cleared 510(K)
K
95
1068
RESOUND ED4-M MINI-CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-M)
1
Cleared 510(K)
K
95
1067
RESOUND ED4-C CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-C)
1
Cleared 510(K)
K
95
1378
RESOUND PERSONAL HEARING SYSTEM MODELS BTP2 & BTP2/S W/REMOTE CONTROL OPTION
1
Cleared 510(K)
K
95
1379
RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTION
1
Cleared 510(K)
K
95
1377
RESOUND PERSONAL HEARING SYSTEM BTP/S-A W/REMOTE CONTROL OPTION
1
Cleared 510(K)
K
95
1376
RESOUND PERSONAL HEARING SYSTEM BT2/S SERIES W/REMOTE CONTROL OPTION
1
Cleared 510(K)
K
95
1375
RESOUND PERSONAL HEARING SYSTEM ED3/S-E
1
Cleared 510(K)
K
95
1374
RESOUND PERSONAL HEARING SYSTEM BT2/S-E
1
Cleared 510(K)
K
94
6340
BELTONE COMPARAFIT
1
Cleared 510(K)
K
95
0759
UNITRON MODEL ESTEEM
1
Cleared 510(K)
K
95
0693
MIRACLE-EAR MODEL PM1/PM2 PROGRAMMABLE HEARING AID
1
Cleared 510(K)
K
95
0692
MIRACLE-EAR MODEL PBS PROGRAMMABLE HEARING AID
1
Cleared 510(K)
K
95
0691
MIRACLE-EAR MODEL PBM PROGRAMMABLE HEARING AID
1
Cleared 510(K)
K
95
0458
SILVER ULTRA MINI CANAL
1
Cleared 510(K)
K
95
0459
GOLD K AMP ULTRA MINI CANAL
1
Cleared 510(K)
K
95
0460
GOLD CD ULTRA MINI CANAL
1
Cleared 510(K)
K
95
0912
MEGA-SIL A-B
1
Cleared 510(K)
K
95
0758
DYNA 231X
1
Cleared 510(K)
K
95
0637
MAICO IN-THE-EAR MODEL RD-312 CIC
1
Cleared 510(K)
K
95
0451
M-29 PP-PC, M-29 PP-O/PC
1
Cleared 510(K)
K
94
5750
RESOUND(R) RESOURCE(TM)
1
Cleared 510(K)
K
95
0381
OTICON/LOGIC
1
Cleared 510(K)
K
94
4896
MATRICS IMPRESSION MATERIAL , SYSTEM
1
Cleared 510(K)
K
94
4851
MICRO MINI PRIMO AGC, MICRO-MINI PRIMO S-AGC
1
Cleared 510(K)
K
95
0319
RESOUND(R) PERSONAL HEARING SYSTEM ED-3 ENCORE
1
Cleared 510(K)
K
95
0080
VIP
1
Cleared 510(K)
K
94
2107
MAGIC EAR, ELAIN
1
Cleared 510(K)
K
94
6323
UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID
1
Cleared 510(K)
K
94
6253
MAICO IN-THE-EAR MODEL RD 201
1
Cleared 510(K)
K
94
6045
OTICON
1
Cleared 510(K)
K
94
6071
LX-ITC
1
Cleared 510(K)
K
94
5726
3M(TM) EAR IMPRESSION MATERIAL
1
Cleared 510(K)
K
94
6294
PHONAK SONO-FORTE 332X-AZ
1
Cleared 510(K)
K
94
6264
UNITRON MODEL SOUNG F/S
1
Cleared 510(K)
K
94
3854
3M MODEL 8233 HEARING INSTRUMENT
1
Cleared 510(K)
K
94
5219
HORMANN HEARING INSTRUMENTS
1
Cleared 510(K)
K
93
4917
RESOUND PERSONAL HEARING SYSTEMS MODIFICATION
1
Cleared 510(K)
K
94
4980
SOUND SELECTOR ITE (SSI), BTE (SSB), MINI BTE( SSM)
1
Cleared 510(K)
K
94
3380
SIEMENS 10A FACEPLATE WITH CIC INSTRUMENTS
1
Cleared 510(K)
K
94
4985
EMSEE LABS MODE M
1
Cleared 510(K)
K
94
4986
EMSEE LABS MODEL C
1
Cleared 510(K)
K
94
4984
EMSEE LABS MODEL S
1
Cleared 510(K)
K
94
4777
ORION PPM, PP, PP-D
1
Cleared 510(K)
K
94
4359
EXPRESSION RX-12, ENHANCEMENT RX-34, ELITE RX-12
1
Cleared 510(K)
K
94
4645
SIEMENS FRONTIER SERICE, MODELS S-1,S-2 AND S-3 MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS
1
Cleared 510(K)
K
94
4520
AIR CONDUCTION HEARING AID
1
Cleared 510(K)
K
94
4518
WIDEX MODEL LOGO 8S
1
Cleared 510(K)
K
94
4404
MO4 SERIES
1
Cleared 510(K)
K
94
4174
LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS
1
Cleared 510(K)
K
94
5710
IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
94
5703
WIDEX MODEL LOGO - L9
1
Cleared 510(K)
K
94
4043
BTP-A HEARING SYSTEM
1
Cleared 510(K)
K
94
4039
BEHIND THE EAR HEARING AID
1
Cleared 510(K)
K
94
5780
FINETONE DISCEET CANAL
1
Cleared 510(K)
K
94
5218
ACTIVE MODEL CIC
1
Cleared 510(K)
K
94
4161
IMAGE
1
Cleared 510(K)
K
94
2702
DEEP CANAL HEARING INSTRUMENT
1
Cleared 510(K)
K
94
3016
ADOBE C.I.C
1
Cleared 510(K)
K
94
5255
MICROSIL
1
Cleared 510(K)
K
94
4009
HEARING AID (ACCESSORY)
1
Cleared 510(K)
K
94
4241
MAGNATONE MODEL M PREWIRED FACEPLATE HEARING AID
1
Cleared 510(K)
K
94
4097
COMPASS SOFTWARE MODULE
1
Cleared 510(K)
K
94
2331
DANAVOX MODEL CIC
1
Cleared 510(K)
K
94
4548
REXPLUS PP3
1
Cleared 510(K)
K
94
4078
PROGRAM 3-CH SER HEAR AIDS W/PROGRAM FIT SYST/PRO FIT
1
Cleared 510(K)
K
94
4838
WIDEX MODEL LX-ITE
1
Cleared 510(K)
K
94
4502
BELTONE CONCERTO S
1
Cleared 510(K)
K
94
3960
UV CURED METHYL METHACRYLATE HEARING AID SHELL MATERIALS
1
Cleared 510(K)
K
94
3687
FEDELITY F495, VIENNATONE ALPP II
1
Cleared 510(K)
K
94
4077
PROGRAM 3-CH SERIES HEAR AIDS W/DT-1 DESKTOP PROGRAM
1
Cleared 510(K)
K
94
3826
MIRACLE-EAR MIRAGE
1
Cleared 510(K)
K
94
2523
MIRACLE-EAR IMPRESSION MATERIAL KIT
1
Cleared 510(K)
K
94
3825
MIRACLE EAR CONFIDANTE
1
Cleared 510(K)
K
94
3788
RESOUND PERSONAL HEARING SYSTEM
1
Cleared 510(K)
K
94
3318
ALL-IN-THE-EAR
1
Cleared 510(K)
K
93
5019
INFINITY 252
1
Cleared 510(K)
K
93
4752
SIEMENS MODEL 584 P-2
1
Cleared 510(K)
K
94
3706
AUDILENS LLK
1
Cleared 510(K)
K
94
2857
SIEMENS BTE HEARING AIDS
1
Cleared 510(K)
K
94
3670
MO6 SERIES
1
Cleared 510(K)
K
94
3682
SM-VEGA, SM-PC, SM-AGC, SM-AGC-H
1
Cleared 510(K)
K
94
2893
MIRACLE-EAR MODEL PGF + REMOTE
1
Cleared 510(K)
K
94
2894
MIRACLE-EAR MODEL PGC
1
Cleared 510(K)
K
94
2895
MIRACLE EAR MODEL PGM
1
Cleared 510(K)
K
94
3395
PHILIPS M38 SERIES
1
Cleared 510(K)
K
94
2189
CRYSTAL EAR
1
Cleared 510(K)
K
94
1107
THE CANAL (C.I.C.) AKA/HIDDEN EAR
1
Cleared 510(K)
K
94
0667
STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AID
1
Cleared 510(K)
K
94
0670
EARCRAFT HEARING AID
1
Cleared 510(K)
K
94
1859
MIRACLE-EAR EAR IMPRESSION MATERIAL
1
Cleared 510(K)
K
94
3144
AURIS CIC
1
Cleared 510(K)
K
94
2829
HAE 1
1
Cleared 510(K)
K
94
2831
HAE 2
1
Cleared 510(K)
K
94
2830
HAE 3
1
Cleared 510(K)
K
94
2749
HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT
1
Cleared 510(K)
K
94
2594
STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID
1
Cleared 510(K)
K
94
0164
SUPER-SIL
1
Cleared 510(K)
K
94
2036
EUROSTAR SUPER, EUROSTAR VFC
1
Cleared 510(K)
K
94
1587
HEARING TECH
1
Cleared 510(K)
K
94
2213
OPTIMA WITH DELTA AMP
1
Cleared 510(K)
K
94
2164
PHILIPS 61 SERIES
1
Cleared 510(K)
K
94
1295
SHARP II HELIX HEARING AID
1
Cleared 510(K)
K
94
0098
BELTONE INVISA
1
Cleared 510(K)
K
94
1734
PHONAK SONO-FORTE 331X BTE HEARING INSTRUMENTS
1
Cleared 510(K)
K
93
2269
PRO-CONNECT
1
Cleared 510(K)
K
94
1293
SHARP II SEMI CONTOUR HEARING AID
1
Cleared 510(K)
K
94
1292
SHARP II FULL CONTOUR
1
Cleared 510(K)
K
94
1294
SHARP II LOW PROFILE HEARING AID
1
Cleared 510(K)
K
94
1133
770-ATC
1
Cleared 510(K)
K
94
1122
AUDIOTONE MODEL A-54SR
1
Cleared 510(K)
K
94
1121
AUDIOTONE MODEL A-54
1
Cleared 510(K)
K
94
1039
WAX GUARD OPTION
1
Cleared 510(K)
K
94
1636
MINI PAK
1
Cleared 510(K)
K
94
1635
INTRA S, INTRA SH
1
Cleared 510(K)
K
94
1508
WIDEX S-21
1
Cleared 510(K)
K
94
1395
BELTON MERIT (HEARING AID)
1
Cleared 510(K)
K
94
1140
RIONET HEARING AID HB-37T
1
Cleared 510(K)
K
94
1021
RIONET HEARING AID HB-54
1
Cleared 510(K)
K
94
0978
STARKEY EUROLINE A SERIES
1
Cleared 510(K)
K
94
0608
155 PP AGC-I
1
Cleared 510(K)
K
93
5962
MIRACLE-EAR WITH POWER CIRCUIT OPTION
1
Cleared 510(K)
K
94
0116
COMPLETELY IN THE CANAL
1
Cleared 510(K)
K
93
6190
BEHIND THE EAR HEARING AID
1
Cleared 510(K)
K
94
0177
OTOSONIC CF-2, CF-2 IC, CF-2 ANF, CF-2 WITH IMPROVED CLASS D (DELTA AMP)
1
Cleared 510(K)
K
94
0101
OTOSONIC ACS II D WITH SRR
1
Cleared 510(K)
K
94
0100
PROFILE IC; PROFILE CLEARVOICE; PROFILE
1
Cleared 510(K)
K
94
0103
BELTONE ODE AND BELTONE ODE VX; ODE CLEARVOICE IC AND BELTONE ODE VX CLEARVOICE IC; BELTONE ODE CLEARVOICE ANF AND
1
Cleared 510(K)
K
94
0102
BELTONE OPERA/OPERA MHP/OPERA MAX
1
Cleared 510(K)
K
94
0099
OTOSONIC (OSI) LPS D; LPS D IC; LPS D ASP
1
Cleared 510(K)
K
94
0639
LORI-CIC HEARING AID
1
Cleared 510(K)
K
94
0104
OTOSONIC MINI PAS
1
Cleared 510(K)
K
93
5867
AIR CONDUCTION HEARING AID, UNITRON IKON K & KD
1
Cleared 510(K)
K
94
0458
MIRACLE-EAR CONFIDANTE
1
Cleared 510(K)
K
93
6122
RIONET HEARING AID HB-53CI
1
Cleared 510(K)
K
93
6106
AIR CONDUCTION HEARING AID: IKON PP
1
Cleared 510(K)
K
93
5424
WIDEX R.C. 2 (REMOTE CONTROL)
1
Cleared 510(K)
K
93
4940
MIRACLE-EAR ENTRE
1
Cleared 510(K)
K
93
6007
PRIZM HEARING SYSTEM, MODEL POWER BTE
1
Cleared 510(K)
K
93
5559
HEARING AIDS HB-36M, HB-36MS, HB-36MT, HI-67P, EXCEL-1000
1
Cleared 510(K)
K
93
5791
PHONAK PICONET 232X-AZ BTE HEARING INSTRUMENT
1
Cleared 510(K)
K
93
5326
NU-EAR SD-10 IN THE CANAL HEARING AID
1
Cleared 510(K)
K
93
5335
NU.EAR SS-10 IN THE CANAL (ITC) HEARING AID
1
Cleared 510(K)
K
93
5334
NU.EAR SD-1 IN THE EAR (ITE) HEARING AID
1
Cleared 510(K)
K
93
5333
NU.EAR SS-1 IN THE EAR (ITE) HEARING AID
1
Cleared 510(K)
K
93
5332
NU.EAR AE-1 IN THE EAR (ITE) HEARING AID
1
Cleared 510(K)
K
93
5331
NU.EAR SD-3 IN THE CANAL (ITC) HEARING AID
1
Cleared 510(K)
K
93
5330
NU.EAR SS-3 IN THE CANAL (ITC) HEARING AID
1
Cleared 510(K)
K
93
5329
NU.EAR AE-2 IN THE CANAL (ITC) HEARING AID
1
Cleared 510(K)
K
93
5328
NU.EAR SS-2 IN THE CANAL (ITC) HEARING AID
1
Cleared 510(K)
K
93
5327
NU.EAR SD-2 IN-THE-CANAL (ITC) HEARING AID
1
Cleared 510(K)
K
93
5366
BINAURAL HEARING AID
1
Cleared 510(K)
K
93
5458
AUDIPHON, MODEL H-11
1
Cleared 510(K)
K
93
4149
MICRO-TECH TRU CANAL
1
Cleared 510(K)
K
93
5289
PRO FIT-CYBER II OPTION
1
Cleared 510(K)
K
93
5420
SOUNDRIGHT, SHP
1
Cleared 510(K)
K
93
5266
MIRACLE EAR MODEL SHARP II MICRO CANAL HEARING AID
1
Cleared 510(K)
K
93
5265
MIRACLE EAR MODEL SHARP II CANAL
1
Cleared 510(K)
K
93
5095
8260 SERIES 3M PROGRAMMABLE HEARING INSTRUMENTS
1
Cleared 510(K)
K
93
3963
PAL (PERSONAL AMPLIFIER FOR LISTENING)
1
Cleared 510(K)
K
93
4565
UNITRON MODEL IKON AGCO/ AOD
1
Cleared 510(K)
K
93
4417
OMNI 2000 SERIES ITC HEARING AID
1
Cleared 510(K)
K
93
4416
OMNI 2000 SERIES ITE HEARING AID
1
Cleared 510(K)
K
93
4618
OTOSONIC ADVANCED FULL SHIELD (AFS)
1
Cleared 510(K)
K
93
4597
CLARIFIER II CIRCUIT OPTION
1
Cleared 510(K)
K
93
4586
PROGRAMMABLE AIR CONDUCTION BEHIND THE EAR HEARING AID
1
Cleared 510(K)
K
93
4480
RIONET HEARING AID HA-73
1
Cleared 510(K)
K
93
4479
RIONET HEARING AID HA-72
1
Cleared 510(K)
K
93
1372
RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM
1
Cleared 510(K)
K
93
3546
V-SIL
1
Cleared 510(K)
K
93
4452
HI BAND
1
Cleared 510(K)
K
93
4453
3-CHANNEL CLOCK
1
Cleared 510(K)
K
93
4454
MANHATTAN II
1
Cleared 510(K)
K
93
4450
MANHATTAN 3-CHANNEL
1
Cleared 510(K)
K
93
4449
3-CHANNEL K-AMP
1
Cleared 510(K)
K
93
4448
POWER 3-CHANNEL-CLOCK
1
Cleared 510(K)
K
93
4447
LINEAR PLUS-POWER
1
Cleared 510(K)
K
93
4446
POWER MANHATTAN II
1
Cleared 510(K)
K
93
4444
K-AMP
1
Cleared 510(K)
K
93
4443
2:1 INPUT COMPRESSION
1
Cleared 510(K)
K
93
4442
LINEAR PLUS
1
Cleared 510(K)
K
93
3988
BOSCH EUROSTAR
1
Cleared 510(K)
K
93
3989
RESOLUTION ITC HEARING AID
1
Cleared 510(K)
K
93
3407
STARKEY TYMPANETTE HEARING AID
1
Cleared 510(K)
K
92
3006
AS-90
1
Cleared 510(K)
K
93
3850
PHILIPS 45 SERIES
1
Cleared 510(K)
K
93
3643
WIDEX MODEL LOGO 6 (L6)
1
Cleared 510(K)
K
93
3640
WIDEX MODEL LOGO 12 (L12)
1
Cleared 510(K)
K
93
3644
WIDEX MODEL LOGO 8 (L8)
1
Cleared 510(K)
K
93
3579
MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING AID
1
Cleared 510(K)
K
93
3307
MULTIFOCUS COMPACT BTE HEARING AID
1
Cleared 510(K)
K
93
3291
MAICO BTE MODEL RD-111 AND ITE MODEL RD-312 HEARING AID
1
Cleared 510(K)
K
93
2703
BELTONE PRIMA 2000
1
Cleared 510(K)
K
93
0909
PRIZM HEARING SYSTEM
1
Cleared 510(K)
K
93
2670
OTICON MF
1
Cleared 510(K)
K
93
3042
SILVER COMPRESSION MODULE, ITE
1
Cleared 510(K)
K
93
3036
GOLD ASP MODULE, ITE
1
Cleared 510(K)
K
93
3113
STARKEY TRILOGY II PROGRAMMABLE HEARING AID
1
Cleared 510(K)
K
93
2734
PHONAK PICO-FORTE SC-2
1
Cleared 510(K)
K
93
2735
PHONAK PICO-FORTE SC-D-2
1
Cleared 510(K)
K
93
3095
351-AGCO BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
93
1942
RESOUND PERSONAL HEARING SYSTEM BT-P W/PHS BT-P
1
Cleared 510(K)
K
93
2426
BELTONE OPERA/OPERA MHP/OPERA MAX
1
Cleared 510(K)
K
92
6150
VINYL ADDITION SILICONE SYSTEM
1
Cleared 510(K)
K
93
2175
PHONAK LEXA 231X ITE SERIES HEARING SINSTRUMENT
1
Cleared 510(K)
K
93
2058
BELTONE OPTIMA 2000 ITE HEARING AID
1
Cleared 510(K)
K
93
1881
IN THE CANAL AID OTOSONIC ACS II WITH SRR
1
Cleared 510(K)
K
92
2501
M30 IN THE EAR HEARING AID
1
Cleared 510(K)
K
92
2502
M32 IN THE EAR HEARING AID
1
Cleared 510(K)
K
93
1975
AUDIOTECH MODEL DP
1
Cleared 510(K)
K
93
2189
IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
93
2105
HEARING AIDS
1
Cleared 510(K)
K
93
1984
PERFECT EAR/PE
1
Cleared 510(K)
K
93
1161
SERIES STAR 22 - BEHIND THE EAR HEARING AID
1
Cleared 510(K)
K
93
1160
SERIES STAR 66 BEKHIND THE EAR HEARING AID
1
Cleared 510(K)
K
93
1041
STAR 42 PP-SP, STAR 42 PP-SL (T100)
1
Cleared 510(K)
K
93
1035
MODELS 33PP, 33PP ANR, & 33PP SUPER HEARING AID
1
Cleared 510(K)
K
93
1040
MT 80 SP
1
Cleared 510(K)
K
93
1590
ITE MODEL ADOBE 100 FULL CUSTOM
1
Cleared 510(K)
K
93
1591
ITC MODEL ADOBE 100 CANAL
1
Cleared 510(K)
K
93
1320
RIONET HEARING AID HB-53W
1
Cleared 510(K)
K
93
1023
IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
93
1158
MEMOREX MODEL 361-AGCO HEARING AID
1
Cleared 510(K)
K
93
1157
BEHIND-THE-EAR HEARING AID, TELEX MODEL 380-PP
1
Cleared 510(K)
K
93
1134
BEHIND-THE-EAR HEARING AID, TELEX MODEL 361-PP
1
Cleared 510(K)
K
93
0999
SIEMENS MODEL 584-P-AI
1
Cleared 510(K)
K
93
0998
SIEMENS MODEL 584-P-GC
1
Cleared 510(K)
K
93
1000
SIEMENS MODEL 584-P-AI-D
1
Cleared 510(K)
K
93
0721
RIONET HEARING AID HB-53S
1
Cleared 510(K)
K
93
0542
HEARING AID (ALL-IN-THE-EAR)
1
Cleared 510(K)
K
93
0853
INTRA V AND SECRET EAR III
1
Cleared 510(K)
K
93
0805
CE-9 IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
93
0715
WIDEX MODEL DX HEARING AID
1
Cleared 510(K)
K
93
0598
OTOSONIC FSD, IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
93
0271
BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
93
0541
VOICEMODE, ITE, AIR-CONDUCTION HEARING AID
1
Cleared 510(K)
K
93
0318
BELTONE OPERA LOR, ITC
1
Cleared 510(K)
K
93
0310
BELTONE OPTIMA 2000 CLEARVOICE SERIES, IN-THE-EAR
1
Cleared 510(K)
K
92
6092
MIRACLE-EAR MODEL HL
1
Cleared 510(K)
K
92
6091
AUDIOTONE MODEL A-98
1
Cleared 510(K)
K
92
5600
VISTA 4000 SIGMA
1
Cleared 510(K)
K
92
6476
SOUNDCHOICE WITH VARIABLE SLOPE
1
Cleared 510(K)
K
92
6085
WIDEX MODEL D16
1
Cleared 510(K)
K
93
0145
PHONAK PICONET 231-X
1
Cleared 510(K)
K
92
6244
WIDEX MODEL D8 (HEARING AID)
1
Cleared 510(K)
K
92
4887
P54-0 BEHIND THE EAR HEARING AID
1
Cleared 510(K)
K
92
4888
P54 HEARING AID
1
Cleared 510(K)
K
92
4350
HEARING AID (ALL-IN-THE-EAR)
1
Cleared 510(K)
K
92
5103
AAHS HEARING AID
1
Cleared 510(K)
K
92
4913
PHONAK PICO-FORTE PPC-L-P-2 BTE HEARING INSTR
1
Cleared 510(K)
K
92
4911
PHONAK PICO-FORTE PP-SC-2 BTE HEARING INSTRUMENT
1
Cleared 510(K)
K
92
4914
PHONAK PICO-FORTE PPC-P-2 BTE HEARING INSTRUMENT
1
Cleared 510(K)
K
92
4912
PHONAK PICO-FORTE C-2 BTE HEARING INSTRUMENT
1
Cleared 510(K)
K
92
4185
DFS GENIUS BTE
1
Cleared 510(K)
K
92
4450
MEDIPHONIX CUSTOM FULL SHELL CUSTOM CANAL
1
Cleared 510(K)
K
92
3292
ITC HEARING AID CLUB MODEL LM50
1
Cleared 510(K)
K
92
3801
RIONET HB75-AL BTE AID
1
Cleared 510(K)
K
92
3743
BTE WITH ACCESSORY ATTACHED
1
Cleared 510(K)
K
92
3735
SOUNDCHOICE K-AMP
1
Cleared 510(K)
K
92
3071
DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT
1
Cleared 510(K)
K
92
3295
ITC HEARING AID CLUB MODEL LM40
1
Cleared 510(K)
K
92
3296
BTE HEARING AID CLUB MODEL ST70
1
Cleared 510(K)
K
92
3293
ITC HEARING AID CLUB MODEL LM50H
1
Cleared 510(K)
K
92
3294
BTE HEARING AID CLUB MODEL: ST60
1
Cleared 510(K)
K
92
3986
CYBERNETIC OPTION (CYBER I)
1
Cleared 510(K)
K
92
3918
IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
92
3784
STARKEY SM SERIES BTE HEARING AIDS
1
Cleared 510(K)
K
92
3924
VOICEWAVE
1
Cleared 510(K)
K
92
3380
SIEMENS MODEL TRITON 3004 B
1
Cleared 510(K)
K
92
3379
SIEMENS MODEL INFINITI 1001 B
1
Cleared 510(K)
K
92
1725
PHILIP XP SERIES, IN-THE CANAL HEARING AID
1
Cleared 510(K)
K
92
3490
BTE HEARING AID PERSONIC 410
1
Cleared 510(K)
K
92
3491
BTE HEARING AID PERSONIC 425
1
Cleared 510(K)
K
92
3388
BTE HEARING AID OTICON MODEL: MULTIFOCUS POWER
1
Cleared 510(K)
K
92
3226
EURION LOTOS PP HEARING AID
1
Cleared 510(K)
K
92
2392
ITE, ITC, OE(OPEN), HS(HALF SHELL) HEARING AID
1
Cleared 510(K)
K
90
5555
A-ZILICONE
1
Cleared 510(K)
K
92
2827
OTOSONIC ACS K
1
Cleared 510(K)
K
92
2708
WIDEX MODEL D32
1
Cleared 510(K)
K
92
2422
PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES
1
Cleared 510(K)
K
92
2301
BELTONE OPERA CLEARVOICE IC, ITC (IN THE CANAL)
1
Cleared 510(K)
K
91
5711
IN THE EAR HEARING AID
1
Cleared 510(K)
K
92
2224
OTOSONIC ACS-IC
1
Cleared 510(K)
K
92
1463
PHILIPS 31 SERIES IN THE EAR HEARING AID
1
Cleared 510(K)
K
92
2065
TELEX MODEL M29 ITE CUSTOM HEARING AID
1
Cleared 510(K)
K
92
2066
TELEX MODEL 28A ITE CUSTOM HEARING AID
1
Cleared 510(K)
K
92
1257
EURION LOTOS P HEARING AID
1
Cleared 510(K)
K
92
1656
LIFESOUND ITE (LSI-I)W/ TRITON 3004I PROGRAMMABLE
1
Cleared 510(K)
K
92
1829
RIONET HEARING AID HB-52S
1
Cleared 510(K)
K
92
1830
RIONET HEARING AID HB-52T
1
Cleared 510(K)
K
92
0911
QCC CUSTOM CANAL AND QE1 ALL ITE
1
Cleared 510(K)
K
92
0657
DI CUSTOM IN THE EAR AND IN THE CANAL
1
Cleared 510(K)
K
92
1122
SOUNDCHOICE BTE
1
Cleared 510(K)
K
92
1023
BELTONE OPRA CLEAR VOICE-K HEARING AID
1
Cleared 510(K)
K
92
0897
RIONET HEARING AID - HB 52DU
1
Cleared 510(K)
K
91
5794
AD-HEAR
1
Cleared 510(K)
K
91
2399
HEARING AID (ALL-IN-THE-EAR)
1
Cleared 510(K)
K
92
0466
EXTEND-EAR
1
Cleared 510(K)
K
91
5450
IN THE EAR HEARING AID
1
Cleared 510(K)
K
92
0522
RIONET HEARING AID HB-23M
1
Cleared 510(K)
K
92
0521
RIONET HEARING AID HB-23T
1
Cleared 510(K)
K
91
4948
AM 300 AGC-O
1
Cleared 510(K)
K
91
4947
AM 300 XP
1
Cleared 510(K)
K
91
4798
PREMIER CLASS D-ASP
1
Cleared 510(K)
K
91
4799
PREMIER K-AMP
1
Cleared 510(K)
K
91
4797
PREMIER CD RECHARGEABLE
1
Cleared 510(K)
K
91
4795
ELECTONE/PA RECHARGEABLE
1
Cleared 510(K)
K
91
4796
PREMIER ASP/CD RECHARGEABLE
1
Cleared 510(K)
K
92
0486
RIONET HEARING AID HB-53P
1
Cleared 510(K)
K
92
0093
AUDIOTONE MODEL A-96
1
Cleared 510(K)
K
92
0134
PHILIPS 41 SERIES RAINBOW
1
Cleared 510(K)
K
91
5614
BTE HEARING AID MULTIFOCUS
1
Cleared 510(K)
K
92
0142
PHILIPS M60 SERIES
1
Cleared 510(K)
K
91
5346
CUSTOM CANAL HEARING AID
1
Cleared 510(K)
K
91
5875
RIONET HEARING AID HB-71K (K-AMP)
1
Cleared 510(K)
K
91
4897
SONOTONE BEHIND THE EAR MODEL ST 54-0
1
Cleared 510(K)
K
91
5683
REXTON RX12 WITH HORIZON PROGRAMMABLE OPTION
1
Cleared 510(K)
K
91
5684
REXTON RX34 WITH HORIZON PROGRAMMABLE OPTION
1
Cleared 510(K)
K
91
5319
RIONET HEARING AID HB-52AS
1
Cleared 510(K)
K
91
5517
SONOTONE BODY AID MODEL ST 1000 BODY WORN
1
Cleared 510(K)
K
91
5519
SONOTONE BEHIND THE EAR MODEL ST 53A
1
Cleared 510(K)
K
91
5518
SONOTONE BEHIND THE EAR MODEL ST 49
1
Cleared 510(K)
K
91
5076
MED-EQUIP CORPORATION
1
Cleared 510(K)
K
91
4899
SONOTONE BEHIND THE EAR MODEL ST 45G
1
Cleared 510(K)
K
91
4898
SONOTONE BEHIND THE EAR MODEL ST 47I
1
Cleared 510(K)
K
91
5461
PHONAK 9000-AF ITE HEARING INSTRUMENT SERIES
1
Cleared 510(K)
K
91
5252
PHILIPS P74P BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
91
4981
OTOSONIC (OSI) LPS IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
91
4982
BELTONE PROFILE IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
91
4940
BELTONE CLEARVOICE
1
Cleared 510(K)
K
91
4939
OTOSONIC ACS-ASP
1
Cleared 510(K)
K
91
4800
P54 BTE HEARING AID
1
Cleared 510(K)
K
91
4689
HEARING AID, UNITRON MODEL VISTA 4000
1
Cleared 510(K)
K
91
4688
HEARING AID, UNITRON MODEL VISTA 3000
1
Cleared 510(K)
K
91
3366
IN-THE-EAR HEARING AIDS
1
Cleared 510(K)
K
91
4477
AUDIOTONE MODEL A-95 BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
91
4418
ACT-II BEHIND THE EAR HEARING AID
1
Cleared 510(K)
K
91
3245
MODEL 80 HEARING AID DISPENSING SYSTEM
1
Cleared 510(K)
K
91
4333
SIEMENS MODEL LS-I W/INFINITI PROGRAMMABLE OPTION
1
Cleared 510(K)
K
91
4017
UC312, ULTRA MINIATURE ITC HEARING AID
1
Cleared 510(K)
K
91
3771
ELEGANCE - KED, BEHIND THE EAR HEARING AID
1
Cleared 510(K)
K
91
3781
QUALITONE 48PP-AGC-I, BEHIND THE EAR HEARING AID
1
Cleared 510(K)
K
91
3592
QUALITONE 46PP-AGC-I
1
Cleared 510(K)
K
91
3502
PHONAK AUDINET PP-C-P BTE HEARING INSTRUMENT
1
Cleared 510(K)
K
91
3503
PHONAK PICO-FORTE PP-C-P BTE HEARING INSTRUMENT
1
Cleared 510(K)
K
91
3390
M32 IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
91
3389
PHILIPS S1594 OTB HEARING AID
1
Cleared 510(K)
K
91
2870
HEARING AID, UNITRON MODEL UIK
1
Cleared 510(K)
K
91
2665
SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID
1
Cleared 510(K)
K
91
1183
NHS 2044P BODY AID, HEARING AID
1
Cleared 510(K)
K
91
2571
PHONAK PHONICA MODEL 312-SC ITE HEARING INSTRUMENT
1
Cleared 510(K)
K
91
2570
PHONAK PHONICA MODEL 312-C ITE HEARING INSTRUMENT
1
Cleared 510(K)
K
91
1810
SIEMENS MODEL 604 PP, BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
91
1811
SIEMENS MODEL 604 PP-L, BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
91
2204
TELEX MODEL TLP, IN-THE-EAR
1
Cleared 510(K)
K
91
2153
QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR
1
Cleared 510(K)
K
91
2154
QUALITONE MODEL 48 C-WR-BEHIND THE EAR
1
Cleared 510(K)
K
91
2339
PHILIPS M30 IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
91
2169
WIDEX MODEL QX IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
91
1707
REGAL, BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
91
1706
MODEL 800, BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
91
1705
CHAMPION, BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
91
1709
STOCK CANAL, IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
91
1708
MODEL E-50, IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
91
1174
NHS 2009SP HEARING AID
1
Cleared 510(K)
K
91
1182
NNHS 2050 SERIES (2055W-2054PP) HEARING AIDS
1
Cleared 510(K)
K
91
1579
STARKEY TRILOGY PROGRAM HEAR AID CC/CE MODELS
1
Cleared 510(K)
K
91
1504
ULTRA & ULTRA LITE II, MODIFICATION
1
Cleared 510(K)
K
91
1497
CUSTOM PERSONAL EAR - CPE
1
Cleared 510(K)
K
91
1498
ADJUSTRETTE - DAO, MODIFICATION
1
Cleared 510(K)
K
91
1499
ELEGANCE - DEO, MODIFICATION
1
Cleared 510(K)
K
91
1211
PHONAK 9100 SC-AF ITE HEARING INSTRUMENT
1
Cleared 510(K)
K
91
1210
PHONAK 9800 SC-AF ITE HEARING INSTRUMENT
1
Cleared 510(K)
K
91
1209
PHONAK 9300 SC-AF ITE HEARING INSTRUMENT
1
Cleared 510(K)
K
91
0325
AHL, ITE MODEL AMERICAN
1
Cleared 510(K)
K
90
5516
MODEL FT40 TRANSONIC(TM) HEARING AID
1
Cleared 510(K)
K
91
0097
ELECTONE ITE MODEL PREMIER
1
Cleared 510(K)
K
90
5740
RESORBABLE BONE PLUG
1
Cleared 510(K)
K
91
1096
DAHLBERG MODEL LZ BTE HEARING AID
1
Cleared 510(K)
K
91
1064
DAHLBERG MODEL LG BTE HEARING AID
1
Cleared 510(K)
K
91
1063
DAHLBERG MODEL LU BTE HEARING AID
1
Cleared 510(K)
K
91
0979
DAHLBERG MODEL LT BTE HEARING AID
1
Cleared 510(K)
K
91
0809
DAHLBERG MODEL LB BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
91
0311
ABRA MODEL LINE LOW DRAIN CUST IN-THE-EAR HEAR AID
1
Cleared 510(K)
K
91
0313
ABRA IPC MODEL INPUT COMPRES AGCCUST ITE HEAR AID
1
Cleared 510(K)
K
91
0314
C ABRA MODEL LINEAR, LOW DR. CUSTOM CANAL HEAR AID
1
Cleared 510(K)
K
91
0312
C ABRA MODEL LINEAR, LOW DRAIN CUST CANAL HEAR AID
1
Cleared 510(K)
K
90
5784
CUSTOM ITE HEARING AID
1
Cleared 510(K)
K
90
5371
ITE HEARING AID
1
Cleared 510(K)
K
90
4756
MATRICS
1
Cleared 510(K)
K
91
0690
3M MODEL 8240 ITE HEARING AID
1
Cleared 510(K)
K
91
0028
POST AURICULAR HEARING AID MODEL PICO SC-H
1
Cleared 510(K)
K
90
5680
543 SERIES BTE
1
Cleared 510(K)
K
91
0743
PHILIPS MODEL S46-OL BTE HEARING AID
1
Cleared 510(K)
K
91
0744
PHILIPS MODEL S46-O BTE HEARING AID
1
Cleared 510(K)
K
91
0704
ACTIVE MODEL AMC MINI CANAL ITE HEARING AID
1
Cleared 510(K)
K
91
0703
ACTIVE MODEL ACA CUSTOM CANAL ITE HEARING AID
1
Cleared 510(K)
K
91
0702
ACTIVE MODEL AHS HALF SHELL ITE HEARING AID
1
Cleared 510(K)
K
91
0701
ACTIVE MODEL ALP LOW PROFILE ITE HEARING AID
1
Cleared 510(K)
K
91
0700
ACTIVE MODEL AST CUSTOM ITE HEARING AID
1
Cleared 510(K)
K
91
0705
ACTIVE MODEL AHX HELIX ITE HEARING AID
1
Cleared 510(K)
K
91
0760
3M MODEL 8242 ITE HEARING AID
1
Cleared 510(K)
K
91
0762
3M MODEL 8244 ITE HEARING AID
1
Cleared 510(K)
K
91
0763
3M MODEL 8245 ITE HEARING AID
1
Cleared 510(K)
K
91
0759
3M MODEL 8241 ITE HEARING AID
1
Cleared 510(K)
K
91
0761
3M MODEL 8243 ITE HEARING AID
1
Cleared 510(K)
K
91
0018
POST AURICULAR HEARING AID MODEL PICO-FORTE PP-SC
1
Cleared 510(K)
K
91
0012
PHONAK MODEL PICO C-S-H-T, BTE HEARING AID
1
Cleared 510(K)
K
91
0206
PHILIPS MODEL S47 BTE HEARING AID
1
Cleared 510(K)
K
91
0148
AM130 AGC-O (BEHIND THE EAR) HEARING AID
1
Cleared 510(K)
K
91
0100
ELECTONE BTE MODEL AM 130 D
1
Cleared 510(K)
K
91
0099
ELECTONE BTE MODEL AM 240 HF
1
Cleared 510(K)
K
91
0101
ELECTONE BTE MODEL AM 130 PP
1
Cleared 510(K)
K
91
0096
ELECTONE BTE MODEL AM900 PP
1
Cleared 510(K)
K
91
0102
ELECTONE BTE MODEL AM 240 PPL
1
Cleared 510(K)
K
91
0103
ELECTONE BTE MODEL AM 130 HF
1
Cleared 510(K)
K
91
0098
ELECTONE BTE MODEL AM 240 PPI
1
Cleared 510(K)
K
90
5692
143 SERIES BTE
1
Cleared 510(K)
K
90
5679
133 SERIES BTE
1
Cleared 510(K)
K
90
5483
MEMORYMATE MODEL 8270 ITE HEARING AID
1
Cleared 510(K)
K
90
3145
HEARSET TELEPHONE HEARING SYSTEM
1
Cleared 510(K)
K
90
4731
QUALITONE ITE GENESIS
1
Cleared 510(K)
K
90
4020
MEMORYMATE HEARING AID WITH PMC PROGRAMMER
1
Cleared 510(K)
K
90
4730
QUALITONE ULTRA CANAL GENESIS
1
Cleared 510(K)
K
90
4576
HEARING AID, UNITRON MODEL UM60-UH
1
Cleared 510(K)
K
90
3473
BEST LABS MODEL S
1
Cleared 510(K)
K
90
3474
BEST LABS MODEL C
1
Cleared 510(K)
K
90
3472
BEST LABS MODEL M
1
Cleared 510(K)
K
90
3471
BEST LABS MODEL P
1
Cleared 510(K)
K
90
4673
OTICAON BTE MODEL E34P
1
Cleared 510(K)
K
90
2846
PRIZM HEARING SYSTEM
1
Cleared 510(K)
K
90
3583
SERIES MCAXX (MODEL 851) ITE HEARING AID
1
Cleared 510(K)
K
90
3479
AUDIOTECH MODEL DB
1
Cleared 510(K)
K
90
3478
AUDIOTECH MODEL CL
1
Cleared 510(K)
K
90
3863
ITE HEARING AID, SOUND MED OPAL MODEL
1
Cleared 510(K)
K
90
3861
ITE HEARING AID, SOUND MED GOLDEN NUGGET MODEL
1
Cleared 510(K)
K
90
3860
ITE HEARING AID, SAAPHIRE MODEL
1
Cleared 510(K)
K
90
3859
ITE HEARING AID, DIAMOND MODEL
1
Cleared 510(K)
K
90
3415
ITE HEARING AID, SOUND MED EMERALD MODEL
1
Cleared 510(K)
K
90
3865
ITE HEARING AID, SOUND MED AMETHYST MODEL
1
Cleared 510(K)
K
90
3864
ITE HEARING AID, PEARL MODEL
1
Cleared 510(K)
K
90
3862
ITE HEARING AID, SOUND MED RUBY MODEL
1
Cleared 510(K)
K
90
2487
MODIFIED HEARING AID (IN-THE-EAR)
1
Cleared 510(K)
K
90
3760
MODEL TRITON 3000 BTE HEARING AID AND PMC SYSTEM
1
Cleared 510(K)
K
90
0632
DYNASTY HEARING SYSTEMS INSTRUMENT
1
Cleared 510(K)
K
90
3295
ESCORT ITC
1
Cleared 510(K)
K
90
2179
VISTA - MODELS V12, V20, V23, V38, ITE HEARING AID
1
Cleared 510(K)
K
90
1833
CE-8 CUSTOM IN-THE-EAR HEARING AIDS
1
Cleared 510(K)
K
90
2290
ITE HEARING AID MODEL PALOMINO
1
Cleared 510(K)
K
90
3023
HERITAGE III (HTC) ITC TYPE HEARING AID
1
Cleared 510(K)
K
90
1341
REXTON RX12 POWER PLUS W/DUAL RECEIVER
1
Cleared 510(K)
K
90
1860
INTRA III AND INTRA IV HEARING AIDS
1
Cleared 510(K)
K
90
2559
CUSTOM IN-THE-EAR HEARING AID OTICON MODEL: P
1
Cleared 510(K)
K
90
2570
ADAM MARK II CUSTOM IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
90
2351
CUSTOM ITE HEARING AID MODELS C AND M
1
Cleared 510(K)
K
90
2352
CUSTOM ITE HEARING AID MODEL: H
1
Cleared 510(K)
K
90
2353
CUSTOM ITE HEARING AID MODELS F AND L
1
Cleared 510(K)
K
90
1745
AUDIOTONE MODEL A-52S BEHIND-THE-EAR HEARING INST.
1
Cleared 510(K)
K
90
1783
AUDIOTONE ITE HEARING AID MODEL ZA (MICRO)
1
Cleared 510(K)
K
90
1747
AUDIOTONE ITE HEARING AID MODEL ZG (MIRAGE)
1
Cleared 510(K)
K
90
1746
AUDIOTONE ITE HEARING AID MODEL ZD (XT)
1
Cleared 510(K)
K
90
1642
WIDEX HEARING AID MODEL THE DISCOVERY
1
Cleared 510(K)
K
90
0846
MODEL 366 HEARING AID
1
Cleared 510(K)
K
90
0831
BTE PICO SCD, PICO SC
1
Cleared 510(K)
K
90
0829
BTE SUPER-FRONT PPSCL, SUPER-FRONT PPSC
1
Cleared 510(K)
K
90
0830
BTE SUPER-FRONT PPCL4, SUPER-FRONT PPC4
1
Cleared 510(K)
K
90
0675
PHONAK ITE 8000, 7000, 6000 ITE HEARING AID
1
Cleared 510(K)
K
89
7033
WIDEX BTE HEARING AID MODEL Q16 WITH REMOTE
1
Cleared 510(K)
K
89
7035
MIRACLE EAR MODEL PC PROG. IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
89
3573
SIEMENS MODEL 284 PP-L
1
Cleared 510(K)
K
89
3575
SIEMENS MODEL 283 ASP
1
Cleared 510(K)
K
89
3576
SIEMENS MODEL 284 PP
1
Cleared 510(K)
K
89
3574
SIEMENS MODEL 284 PP-AGC
1
Cleared 510(K)
K
89
7154
NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE
1
Cleared 510(K)
K
89
6995
DISCRETION, IN THE CANAL HEARING INSTRUMENT
1
Cleared 510(K)
K
90
1351
SEARS MODEL 9098 ITE HEARING AID
1
Cleared 510(K)
K
90
1350
SEARS MODEL 9094 ITE HEARING AID
1
Cleared 510(K)
K
90
1569
BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL
1
Cleared 510(K)
K
90
1556
AUDIOTONE MODEL FFI ITE HEARING AID
1
Cleared 510(K)
K
89
7024
MODEL AUDINA ITE HEATING AID
1
Cleared 510(K)
K
89
1556
EXAM GLOVES (VINYL) MFG. GLORIOUS WEALTH CO.
1
Cleared 510(K)
K
90
1469
SEARS MODEL LF9096 IN-THE-EAR HEARING INSTRUMENT
1
Cleared 510(K)
K
90
1470
SEARS MODEL JCS IN-THE-EAR HEARING INSTRUMENT
1
Cleared 510(K)
K
90
1387
SEARS MODEL LI9097 IN-THE-EAR HEARING INSTRUMENT
1
Cleared 510(K)
K
90
1388
SEARS MODEL LM9091 IN-THE-EAR HEARING INSTRUMENT
1
Cleared 510(K)
K
90
1389
SEARS MODEL LC9092 IN-THE-EAR HEARING INSTRUMENT
1
Cleared 510(K)
K
89
5843
AHAC ITE MODEL ENTENDRE
1
Cleared 510(K)
K
90
1386
SEARS MODEL LS9093 IN-THE-EAR HEARING INSTRUMENT
1
Cleared 510(K)
K
90
0862
DAHLBERG MODEL JM IN-THE-EAR HEARING INSTRUMENT
1
Cleared 510(K)
K
90
1317
WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL
1
Cleared 510(K)
K
90
1316
WIDEX MODEL Q9, BTE W/QUATRO REMOTE CONTROL
1
Cleared 510(K)
K
90
1292
OTICON BTE HEARING AID (BEHIND-THE-EAR), MODEL E44
1
Cleared 510(K)
K
90
0968
HEARING AID (ALL-IN-THE-EAR)
1
Cleared 510(K)
K
90
0861
DAHLBERG MODEL JH IN-THE-EAR HEARING INSTRUMENT
1
Cleared 510(K)
K
90
0789
HEARING AID (ALL-IN-THE-EAR)
1
Cleared 510(K)
K
90
0636
REXTON PP 142, PP 142-L
1
Cleared 510(K)
K
89
5982
WIDEX HEARING AID MODEL ES 10 ASP T
1
Cleared 510(K)
K
89
5981
WIDEX HEARING AID MODELS ES9T AND ES9H
1
Cleared 510(K)
K
90
0692
DAHLBERG MODEL JMS IN-THE-EAR HEARING INSTRUMENT
1
Cleared 510(K)
K
90
0050
MIRACLE EAR MODEL CK IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
89
3004
HEARING AID (ALL-IN-THE-EAR)
1
Cleared 510(K)
K
89
5368
IN THE EAR HEARING AID
1
Cleared 510(K)
K
90
0237
MIRACLE EAR MODEL SM IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
90
0238
MIRACLE EAR MODEL SK IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
89
6463
RESOUND CUSTOM IN-THE CANAL HEARING AID MODEL CA1
1
Cleared 510(K)
K
89
3887
BESTONE MODEL ITE & CANAL
1
Cleared 510(K)
K
89
6159
DAHLBERG MODEL LP BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
89
6158
DAHLBERG MODEL LA BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
89
6157
DAHLBERG MODEL LH BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
89
6057
MINI PRIMO PLUS ASP BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
89
6056
REXTON RX12D CUSTOM IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
89
5590
ITE HEARING AID MODEL PA
1
Cleared 510(K)
K
89
5517
AURAL-TECH ITE HEARING AID MODEL AT-1S, 1SA, 1SC
1
Cleared 510(K)
K
89
1914
ITC PRESCRIPTION SERIES MODEL CA AND C
1
Cleared 510(K)
K
89
4176
FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA
1
Cleared 510(K)
K
89
5134
3M INSTANT FIT CUSTOM EARMOLD
1
Cleared 510(K)
K
89
4428
HEARING AID (IN-THE-EAR)
1
Cleared 510(K)
K
89
5140
CUSTOM IN-THE-CANAL (ITC) HEARING AID MODEL I54
1
Cleared 510(K)
K
89
4414
HEARING AID (IN-THE-CANAL)
1
Cleared 510(K)
K
89
3721
LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT
1
Cleared 510(K)
K
89
3722
LORI-MODEL H, HALF CONCHA IN-THE-EAR INSTRUMENT
1
Cleared 510(K)
K
89
3723
LORI-MODEL L, CANAL IN-THE-EAR INSTRUMENT
1
Cleared 510(K)
K
89
3528
OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID
1
Cleared 510(K)
K
89
2898
ASTRO BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
89
3927
RESOUND CUSTOM IN-THE CANAL HEARING AID PHS-3
1
Cleared 510(K)
K
89
3432
PERSONAL AMPLIFIER RECHARGEABLE MODEL TRIUMPH II
1
Cleared 510(K)
K
89
2338
BEHIND-THE-EAR HEARING AID MODEL 48 AGCI
1
Cleared 510(K)
K
89
1915
ITE PRESCRIPTION SERIES MODEL LP
1
Cleared 510(K)
K
89
1916
ITE PRESCRIPTION SERIES MODEL PP + F
1
Cleared 510(K)
K
89
2803
PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911
1
Cleared 510(K)
K
89
0271
ALPHA MODEL I ITE HEARING AID
1
Cleared 510(K)
K
89
3433
PERSONAL AMPLIFIER MODEL ULTRA HELIX
1
Cleared 510(K)
K
89
2457
TELSTAR MODEL 1/3 ITE HEARING AID
1
Cleared 510(K)
K
89
2458
TELSTAR MODEL F ITE HEARING AID
1
Cleared 510(K)
K
89
2459
TELSTAR MODEL C ITE HEARING AID
1
Cleared 510(K)
K
89
2460
TELSTAR MODEL PP ITE HEARING AID
1
Cleared 510(K)
K
89
2336
BEHIND-THE-EAR HEARING AID MODEL 48 PP PC
1
Cleared 510(K)
K
89
2333
REXTON RX12PP, RX20PP & RX34PP IN-THE-EAR HEAR AID
1
Cleared 510(K)
K
89
0525
INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA
1
Cleared 510(K)
K
89
0102
ITC & ITE HEARING AID, HEAR CLEAR MODELS 1-4
1
Cleared 510(K)
K
89
2337
BEHIND-THE-EAR HEARING AID MODEL 46 PP PC
1
Cleared 510(K)
K
89
1594
CERUMEN FILTER
1
Cleared 510(K)
K
89
1251
BEHIND-THE-EAR HEARING AID MODEL 408 W-H
1
Cleared 510(K)
K
89
1248
BEHIND-THE-EAR HEARING AID MODEL 304 PP-AGC-I
1
Cleared 510(K)
K
89
1250
BEHIND-THE-EAR HEARING AID MODEL 264 D-PP-PC
1
Cleared 510(K)
K
89
1249
BEHIND-THE-EAR HEARING AID MODEL 303 ASP
1
Cleared 510(K)
K
89
1011
RESOUND ITC HEARING ENHANCEMENT SYS HES2, W/REMOTE
1
Cleared 510(K)
K
88
4997
ITE HEARING AID PARKER/TECHNITONE, MODEL PA
1
Cleared 510(K)
K
89
0703
CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A
1
Cleared 510(K)
K
89
0704
BTE HEARING AID OTICON MODEL: E42P
1
Cleared 510(K)
K
88
5128
WIDEX BTE HEARING AID MODEL Q8
1
Cleared 510(K)
K
88
4871
RESOUND HES, DIGITALLY PROGR., ITE HEARING AID
1
Cleared 510(K)
K
88
4583
BTE HEARING AID SIEMENS MODEL 284PP-ASP
1
Cleared 510(K)
K
88
2633
ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID
1
Cleared 510(K)
K
88
4288
HEARING AID, UNITRON BTE MODEL UM60-AGC0
1
Cleared 510(K)
K
88
4113
HEARING AID WIDEX BTE
1
Cleared 510(K)
K
88
3773
H.A.C. MODEL-B (ALL IN THE CANAL)
1
Cleared 510(K)
K
88
3772
H.A.C. MODEL-A (ALL IN THE EAR)
1
Cleared 510(K)
K
88
3961
UNIMAX(TM) HEARING AID BTE MODELS:100S, 110C, PPS4
1
Cleared 510(K)
K
88
2678
ITE HEARING AID, SIEMENS MODEL 007, WITH TELOS
1
Cleared 510(K)
K
88
2721
ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR
1
Cleared 510(K)
K
88
3513
HEARING AID, UNITRON MODEL VISTA 1000
1
Cleared 510(K)
K
88
2691
MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX
1
Cleared 510(K)
K
88
2471
ITE HEARING AID, EARTECH/CUSTOM AID MODEL CA
1
Cleared 510(K)
K
88
1480
FIRST AMERICAN, RADIONIC, JKR, MODEL AC
1
Cleared 510(K)
K
88
2375
HEARING AID, UNITRON MODEL UI5
1
Cleared 510(K)
K
88
1299
ITE HEARING AID, EAR-TRONICS MODELS: M1-M23
1
Cleared 510(K)
K
88
1754
ITE TYPE HEARING AID H.A.F. MODEL ELITE
1
Cleared 510(K)
K
88
2692
MODEL P20/P21 IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
88
2005
HARMONY HEARING AID MODELS LP, M, HO, HF, & C
1
Cleared 510(K)
K
88
2150
HEARING AID (ALL-IN-THE-EAR)
1
Cleared 510(K)
K
88
1417
DAHLBERG MODEL GP BODY AID
1
Cleared 510(K)
K
88
2004
AUDINA
1
Cleared 510(K)
K
88
1612
DAHLBERG MODEL XJ 8080 BODY-WORN HEARING AID
1
Cleared 510(K)
K
88
1193
ACCUTONE IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
88
1143
IMPULSE TVC (RICHARDS, OMNI, MARCON)
1
Cleared 510(K)
K
88
1738
AUDIOTONE MODEL TLC SECRET IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
88
1737
AUDIOTONE MODEL AVATAR IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
88
1653
AUDIOTONE MODEL ASP SECRET IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
88
0938
ITE TYPE HEARING AID ABS MODEL
1
Cleared 510(K)
K
88
1652
AUDIOTONE MODEL A-61 BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
88
1296
HEARING AID (ALL-IN-THE-EAR)
1
Cleared 510(K)
K
88
0969
STAR 22,33,66 SERIES & STARKEY H. AND SM SERIES
1
Cleared 510(K)
K
88
0333
CUSTOM I.T.E. HEARING AIDS CE-5, CE-6, CE-7
1
Cleared 510(K)
K
88
0335
INTRA II SECRET EAR HEARING AIDS ISE
1
Cleared 510(K)
K
88
0334
CUSTOM CANAL HEARING AIDS INTRA II CC-5, 6 & 7
1
Cleared 510(K)
K
88
0273
WIDEX HEARING AID MODEL C1
1
Cleared 510(K)
K
88
0223
MAGIC EAR MODEL MB BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
88
0635
IN THE EAR HEARING AID
1
Cleared 510(K)
K
88
0225
MAGIC EAR MODEL CI IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
88
0184
VIBRASOUND IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
88
0082
MEMORYMATE HEARING AID MODEL 8200
1
Cleared 510(K)
K
88
0349
MODEL 759 CUSTOM IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
88
0224
MAGIC EAR MODEL MC BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
88
0284
ADDVANTAGE:TVC MARCON
1
Cleared 510(K)
K
88
0465
SERIES S515/S525 BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
88
0466
SERIES S415/S425 - BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
88
0286
OMNI ITC TYPE HEARING AID MODEL U-IMPULSE SP
1
Cleared 510(K)
K
88
0285
RICHARDS ITC TYPE HEARING AID MODEL IMPULSE SP
1
Cleared 510(K)
K
87
5010
IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
87
4510
RIONET HEARING AID HB-75
1
Cleared 510(K)
K
87
4831
AUDIOTONE MODEL A2000 BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
87
4830
MIRACLE EAR MODEL BP BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
87
4651
OTICON HEARING AID MODEL I52
1
Cleared 510(K)
K
87
4369
CONCHA, CAVUM, CANAL, CONCHA-P HEARING AID
1
Cleared 510(K)
K
87
4384
AUDIOTONE MODEL A-90, BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
87
5009
IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
87
4385
AUDIOTONE MODEL MSP, IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
87
4380
BTE HEARING AID OTICON MODEL E38P
1
Cleared 510(K)
K
87
4381
BTE HEARING AID OTICON MODEL E39PL
1
Cleared 510(K)
K
87
4707
POST AURICULAR HEARING AID 46PP-PC SUMMIT
1
Cleared 510(K)
K
87
4218
HEARING AID (ALL-IN-THE-EAR)
1
Cleared 510(K)
K
87
4764
HEARING AID (ALL-IN-THE-EAR) MODEL WORD SORTER
1
Cleared 510(K)
K
87
4744
OTICON MODEL I50 IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
87
3736
NICOLET DIGITAL TWO PIECE HEARING AID
1
Cleared 510(K)
K
87
3003
HEARING AID (ALL-IN-THE-EAR)
1
Cleared 510(K)
K
87
4589
BERNAFON COLIBRI, C-2H HEARING AIDS
1
Cleared 510(K)
K
87
4323
MODEL A-70, BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
87
4304
PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL
1
Cleared 510(K)
K
87
4324
MODEL A-17, BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
87
4325
MODEL A-72, BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
87
3490
HEARING AID (ALL-IN-THE-EAR)
1
Cleared 510(K)
K
87
3798
INTERNATIONAL MODEL XP BEHIND-THE-EAR
1
Cleared 510(K)
K
87
3800
INTERNATIONAL MODEL XM BEHIND-THE-EAR
1
Cleared 510(K)
K
87
3799
INTERNATIONAL MODEL XL BEHIND-THE-EAR
1
Cleared 510(K)
K
87
3559
U-IMPULSE TVC AIR CONDUCTION HEARING AID
1
Cleared 510(K)
K
87
3560
U-IMPULSE AIR CONDUCTION IN-THE-CANAL HEARING AID
1
Cleared 510(K)
K
87
3468
CUSTOM IN-THE-EAR HEARING AID SERIES MCA20
1
Cleared 510(K)
K
87
3210
TELSTAR MODEL PP
1
Cleared 510(K)
K
87
3189
HEARING AID (ALL-IN-THE-EAR)
1
Cleared 510(K)
K
87
3169
DAHLBERG MODEL GH BODY AID
1
Cleared 510(K)
K
87
2995
HEARING AID (ALL IN THE EAR)
1
Cleared 510(K)
K
87
2977
HEARING AID (ALL-IN-THE-EAR)
1
Cleared 510(K)
K
87
2922
IN THE EAR HEARING AID
1
Cleared 510(K)
K
87
3070
HEARING AID (IN-THE-EAR)
1
Cleared 510(K)
K
87
3376
MODEL SI AND SP BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
87
3397
DAHLBERG MODEL MH BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
87
3338
HORN CUSTOM AID
1
Cleared 510(K)
K
87
3001
HEARING AID (ALL-IN-THE-EAR)
1
Cleared 510(K)
K
87
2647
INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EAR
1
Cleared 510(K)
K
87
2152
SIEMENS SILICONE IMPRESSION MATERIAL
1
Cleared 510(K)
K
87
2552
HEARING-AID
1
Cleared 510(K)
K
87
2372
BEHIND-THE-EAR HEARING AID OTICON E40
1
Cleared 510(K)
K
87
2374
WIDEX HEARING AID MODEL ES1
1
Cleared 510(K)
K
87
2348
HEARING AID
1
Cleared 510(K)
K
87
2474
POST-AURICULAR HEARING AID MODEL PE 805 SCD2
1
Cleared 510(K)
K
87
2473
POST-AURICULAR HEARING AID MODEL PE 805CD2
1
Cleared 510(K)
K
87
2375
WIDEX HEARING AID MODEL ES6
1
Cleared 510(K)
K
87
2554
HEARING AID 49 SERIES
1
Cleared 510(K)
K
87
2556
HEARING AID M35/M36 SERIES
1
Cleared 510(K)
K
87
2553
HEARING AID S45 SERIES
1
Cleared 510(K)
K
87
2555
HEARING AID 47 SERIES
1
Cleared 510(K)
K
87
2212
HEARING AID (ALL-IN-THE-EAR)
1
Cleared 510(K)
K
87
2017
BTE HEARING AID OTICON MODEL E30P
1
Cleared 510(K)
K
87
1520
TELSTAR MODEL FS HEARING AID
1
Cleared 510(K)
K
87
1518
TELSTAR MODEL F3TS HEARING AID
1
Cleared 510(K)
K
87
1522
TELSTAR MODEL C HEARING AID
1
Cleared 510(K)
K
87
1521
FULL SHELL ITE HEARING AID
1
Cleared 510(K)
K
87
1519
TELSTAR MODEL 0/3 HEARING AID
1
Cleared 510(K)
K
87
1525
DAHLBERG MODEL UL IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
87
1524
DAHLBERG MODEL UH IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
87
1205
CUSTOM IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
87
0985
3M INSTANT FIT CUSTOM EARMOLD
1
Cleared 510(K)
K
87
0982
HEARING AID
1
Cleared 510(K)
K
87
0723
HEARTECH HFX, HEARING AID
1
Cleared 510(K)
K
87
0691
DAHLBERG MODEL UV TRIMLINE IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
87
0503
HEARING AID, UNITRON MODEL UM60
1
Cleared 510(K)
K
87
0435
MODEL 350 WIRELESS CROS/CROS LOW OUTPUT HEAR. AID
1
Cleared 510(K)
K
87
0434
MODEL 350 WIRELESS BICROS/MULTICROS HEARING AIDS
1
Cleared 510(K)
K
87
0350
ESCORT EC CUSTOM IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
87
0081
MICRO-EAR LOW-PROFILE IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
87
0080
MICRO-EAR FULL-CONCHA IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
87
0079
MICRO-EAR CANAL IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
86
4672
PHONIC EAR MODELS PE 811CS AND PE 811CST
1
Cleared 510(K)
K
86
4277
UNIMAX ITE & ULTRAMAX-CCR CUSTOM CANAL INSTRUMENTS
1
Cleared 510(K)
K
86
4823
BEHIND THE EAR HEARING AIDS, BERNAFON COLIBRI, C1
1
Cleared 510(K)
K
86
4031
MODEL AK 8184 CUSTOM-LOW-PROFILE HEARING AID
1
Cleared 510(K)
K
86
4028
MODEL AQ8181 CUSTOM-CANAL-IN-THE EAR HEARING AID
1
Cleared 510(K)
K
86
4029
AY8182 CUSTOM-SEMI CANAL-IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
86
4030
MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
86
3975
CUSTOM IN-THE-EAR
1
Cleared 510(K)
K
86
4180
INTEGRA, CUSTOM IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
86
4097
WIDEX HEARING AID MODEL ES2
1
Cleared 510(K)
K
86
3225
UNITRON MODEL UL21 HEARING AID
1
Cleared 510(K)
K
86
2981
OTICON I31 INITIALES HEARING AID
1
Cleared 510(K)
K
86
3787
PA EQUALIZER
1
Cleared 510(K)
K
86
2980
OTICON I31 CITE HEARING AID
1
Cleared 510(K)
K
86
2623
I81 INITIALES
1
Cleared 510(K)
K
86
2754
CUSTOM IN-THE-EAR AND CANAL HEARING AID
1
Cleared 510(K)
K
86
2622
I22 CITE
1
Cleared 510(K)
K
86
2760
HEARING AID, UNITRON MODEL UF11
1
Cleared 510(K)
K
86
2670
RIONET HEARING AID HB-35PT
1
Cleared 510(K)
K
86
2229
PHONIC EAR PE 602 PPCS
1
Cleared 510(K)
K
86
2169
ALPHA ALL-IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
86
2545
HEARING AID (ALL-IN-EAR)
1
Cleared 510(K)
K
86
2222
INEARSET IES HEARING AID
1
Cleared 510(K)
K
86
2095
MODEL CA, HEARING AID
1
Cleared 510(K)
K
86
2102
MODEL KM IN-THE-CANAL HEARING AID
1
Cleared 510(K)
K
86
2100
MODEL ED BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
86
2099
DAHLBERG MODEL EE BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
86
2101
MODEL UM IN-THE-CANAL HEARING AID
1
Cleared 510(K)
K
86
2104
MODEL UC SPECTRUM IN-THE-CANAL HEARING AID
1
Cleared 510(K)
K
86
2103
MODEL UC IN-THE-CANAL HEARING AID
1
Cleared 510(K)
K
86
2050
LIFESOUND CUSTOM ITE
1
Cleared 510(K)
K
86
2036
MODEL HP HEARING AID
1
Cleared 510(K)
K
86
1939
MODEL PC HEARING AID
1
Cleared 510(K)
K
86
1532
RX-33S INTRA MINI CANAL MODULE
1
Cleared 510(K)
K
86
1597
BEHING-THE-EAR HEARING AID SERIES SP
1
Cleared 510(K)
K
86
1728
RIONET HEARING AID
1
Cleared 510(K)
K
86
1492
HEARING AID (ALL IN THE EAR)
1
Cleared 510(K)
K
85
4637
LEE ELECTRONICS PAL
1
Cleared 510(K)
K
86
1254
MODEL ST HEARING AID
1
Cleared 510(K)
K
86
0170
VOROBA TECHNOLOGIES, ASSOC. QUANTUM HEARING AID
1
Cleared 510(K)
K
85
4311
EARLENS
1
Cleared 510(K)
K
86
0759
CHARISMA HEARING AID
1
Cleared 510(K)
K
86
0670
DAHLBERG MODEL UT IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
86
0671
DAHLBERG MODEL EF BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
85
4124
CRAIGWELL AID HA300
1
Cleared 510(K)
K
86
0512
TELESTAR I, HEARING AID
1
Cleared 510(K)
K
86
0035
MODEL 353C HEARING AID
1
Cleared 510(K)
K
86
0244
A & M 150 PP (HEARING AID)
1
Cleared 510(K)
K
86
0190
A & M DISCREET - HEARING AID
1
Cleared 510(K)
K
86
0191
PA PRESIDENTIAL II - HEARING AID
1
Cleared 510(K)
K
86
0007
AM 12, HEARING AID
1
Cleared 510(K)
K
86
0008
AM 31, HEARING AID
1
Cleared 510(K)
K
85
5240
BEHIND THE EAR HEARING AIDS MODEL
1
Cleared 510(K)
K
85
4834
DAHLBERG MODEL KC IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
85
4438
THE ANSWER HEARING AID
1
Cleared 510(K)
K
85
4742
OTICON, CITEC CUSTOM MADE HEARING AID CANAL TYPE
1
Cleared 510(K)
K
85
4315
HEARTECH MODEL IN TECH
1
Cleared 510(K)
K
85
4001
CERTI-FORM
1
Cleared 510(K)
K
85
3967
HI-TECH LAB MODEL CONCHA ALL IN EAR
1
Cleared 510(K)
K
85
2656
MODEL M HEARING AID
1
Cleared 510(K)
K
85
3895
AUDTEX 85
1
Cleared 510(K)
K
85
3942
INT'L MODEL XE BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
85
3941
INT'L MODEL XG BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
85
3793
WIDEX MODEL M1
1
Cleared 510(K)
K
85
3381
OE SERIES OF BEHIND-THE-EAR HEARING AIDS
1
Cleared 510(K)
K
85
3780
UNITRON MODEL UM60-D
1
Cleared 510(K)
K
85
3781
UNITRON MODEL UM60-PP
1
Cleared 510(K)
K
85
2244
HEARING AID(ALL IN EAR)
1
Cleared 510(K)
K
85
3605
PERSONAL AMPLIFIER SLIMLINE III
1
Cleared 510(K)
K
85
3172
INTERNATIONAL MODEL SC CANAL IN THE EAR HEARING AI
1
Cleared 510(K)
K
85
3170
INTERNATIONAL MODEL SC CUSTOM IN THE EAR HEARG AID
1
Cleared 510(K)
K
85
3171
INTERNATIONAL MODEL SC SEMICANAL IN THE EAR HEAR A
1
Cleared 510(K)
K
85
3637
RIONET HEARING AID HI-07
1
Cleared 510(K)
K
85
3636
RIONET HEARING AID HI-06
1
Cleared 510(K)
K
85
3638
RIONET HEARING AID
1
Cleared 510(K)
K
85
3606
PERSONAL AMPLIFIER COMMUNICATOR PREMIUM
1
Cleared 510(K)
K
85
3324
DAHLBERG EB BEHING-THE-EAR HEARING AID
1
Cleared 510(K)
K
85
3323
DAHLBERG EA BEHING-THE-EAR HEARING AID
1
Cleared 510(K)
K
85
3325
DAHLBERG EC BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
85
3264
HEARING AID MODEL 337D
1
Cleared 510(K)
K
85
3218
HEARTECH MODEL(HTC) (HERITAGE)
1
Cleared 510(K)
K
85
3219
HEARTECH MODEL CH
1
Cleared 510(K)
K
85
3220
HEARTECH MODEL ILLUSION
1
Cleared 510(K)
K
85
3173
INTERNATION MODEL SS STOCK CANAL IN THE EAR H.A.
1
Cleared 510(K)
K
85
3108
MODEL 372L HEARING AID
1
Cleared 510(K)
K
85
2486
DAH/BERG MODEL HP BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
85
2453
RIONET HEARING AID HB-69HT
1
Cleared 510(K)
K
85
2452
RIONET HEARING AID HB-71P
1
Cleared 510(K)
K
85
2451
RIONET HEARING AID HB-34HT
1
Cleared 510(K)
K
85
2098
DAHLBERG MODEL US SPECTRUM IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
85
2052
HEARING AID(ALL IN THE EAR(ALL IN THE CANAL
1
Cleared 510(K)
K
85
2690
HEARING AID, UNITRON MODEL UM60-H
1
Cleared 510(K)
K
85
1866
DAHLBERG MODEL DB BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
85
1869
DAHLBERG MODEL DC BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
85
1867
DAHLBERG MODEL DD BEHING-THE-EAR HEARING AID
1
Cleared 510(K)
K
85
1810
MODEL DA BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
85
1868
DAHLBERT MODEL DE BEHING-THE-EAR HEARING AID
1
Cleared 510(K)
K
85
1427
HEARING AID(ALL IN THE EAR)
1
Cleared 510(K)
K
85
0980
CRESTLINE CL IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
85
1069
BODY TYPE HEARING AID 107S
1
Cleared 510(K)
K
85
0914
HEARING AID, UNITRON MODEL UC
1
Cleared 510(K)
K
85
1970
QUALITONE STOCK CANAL AID
1
Cleared 510(K)
K
85
0981
CRESTLINE CB BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
85
1547
BEHIND THE EAR HEARING AID MODEL BERNAFON T-82
1
Cleared 510(K)
K
85
1429
EARETTE HEARING AID(BEHIND THE EAR OTICON E35F
1
Cleared 510(K)
K
85
1430
EARETTE HEARING AID(BEHIND THE EAR OTICON E37F
1
Cleared 510(K)
K
85
0188
BOSCH IN THE EAR HEARING AID SUPERSTAR
1
Cleared 510(K)
K
84
4862
POST-AURICULAR HEARING AID MODEL PE 600PPCH
1
Cleared 510(K)
K
84
4859
POST-AURICULAR HEARING AID MODEL PE 600 PPC
1
Cleared 510(K)
K
84
4863
POST-SURICULAR HEARING AID PE 600CD
1
Cleared 510(K)
K
84
4861
POST-AURICULAR HEARING AID MODEL PE 600PPCL
1
Cleared 510(K)
K
84
4860
POST-AURICULAR HEARING AID MODEL PE 600CHD
1
Cleared 510(K)
K
85
0763
EARETTE HEARING AID OTICON E32U
1
Cleared 510(K)
K
85
0762
EARETTE HEARING AID OTICON MODEL E32S
1
Cleared 510(K)
K
85
0243
HEARING AID 365
1
Cleared 510(K)
K
85
0185
BODY HEARING AIDS MT 80 SP
1
Cleared 510(K)
K
85
0187
BOSCH STARR 66PP -HEARING AIDS
1
Cleared 510(K)
K
85
0190
STAR 66F-AGC-I HEARING AID
1
Cleared 510(K)
K
85
0189
BOSCH STAR 66PP-S HEARING AID
1
Cleared 510(K)
K
85
0123
IN-TH-EAR HEARING AID
1
Cleared 510(K)
K
84
4093
JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR
1
Cleared 510(K)
K
84
4985
IN THE EAR MODEL X-ITE 84
1
Cleared 510(K)
K
84
4728
ADVANCED HEARING INSTRUMENTS - HEARING AIDS
1
Cleared 510(K)
K
84
3484
MECON X (TEN)
1
Cleared 510(K)
K
84
3246
HEARING AID, UNITRON UE12-PPL
1
Cleared 510(K)
K
84
3245
HEARING AID, UNITRON UE12-PP
1
Cleared 510(K)
K
84
4648
MODEL 363C HEARING AID
1
Cleared 510(K)
K
84
4621
BEHIND THE EAR HEARING AID BERNAFON T-88P
1
Cleared 510(K)
K
84
4425
BEHIND THE EAR HEARING AIDS BERNAFON X-13
1
Cleared 510(K)
K
84
3789
ULTRA & ULTRA MINATURE
1
Cleared 510(K)
K
84
3574
HEARING AID - ALL IN THE EAR
1
Cleared 510(K)
K
84
4059
RIONET HEARING AID HB-34AS
1
Cleared 510(K)
K
84
3068
HEARING AIDS 372 & 372 AI
1
Cleared 510(K)
K
84
3980
PERSONAL AMPLIFIER SILENCER
1
Cleared 510(K)
K
84
4000
RIONET HEARING AID HB-73
1
Cleared 510(K)
K
84
3791
BEHIND-THE-EAR 123 VTH
1
Cleared 510(K)
K
84
2832
A.S.P.C./CLEARSOUND
1
Cleared 510(K)
K
84
3921
IN THE CANAL HEARING AID RC, REDICANAL
1
Cleared 510(K)
K
84
3144
K-BASS LO FREQUENCY HEARING AID
1
Cleared 510(K)
K
84
1934
RADIOEAR M430 PP
1
Cleared 510(K)
K
84
3067
TCA HEARING AID
1
Cleared 510(K)
K
84
2980
IN-THE-EAR-CANAL HEARING AID
1
Cleared 510(K)
K
84
2546
CUSTOM CANAL HEARING AID X-CITE 84
1
Cleared 510(K)
K
84
2875
RIONET HEARING AID HB-35
1
Cleared 510(K)
K
84
2434
BEHING THE EAR HEARING AID T-98
1
Cleared 510(K)
K
84
2073
EARETTE HEARING AID OTICON E31V
1
Cleared 510(K)
K
84
2074
EARETTE HEARING AID OTICON E30V
1
Cleared 510(K)
K
84
1935
RIONET HEARING AID HI-03
1
Cleared 510(K)
K
84
1933
RADIOEAR M420H
1
Cleared 510(K)
K
84
0893
CONFERETTE C2
1
Cleared 510(K)
K
84
1436
OTICON E28A
1
Cleared 510(K)
K
84
1475
HEARING AID MODEL M400
1
Cleared 510(K)
K
84
1474
HEARING AID MODEL P500
1
Cleared 510(K)
K
84
1473
HEARING AID MODEL 440PPC
1
Cleared 510(K)
K
83
3486
IN-THE-EAR HEARING AID MODEL
1
Cleared 510(K)
K
84
0906
HEARING AID AUDIO-STARR A
1
Cleared 510(K)
K
84
0891
IN-THE-EAR HEARING AID RX10 & 20
1
Cleared 510(K)
K
84
0728
HEARING AIDS IN-THE-EAR
1
Cleared 510(K)
K
84
0298
MCA IN THE EAR CUSTOM HEARING AID
1
Cleared 510(K)
K
84
0165
CANAL AID
1
Cleared 510(K)
K
84
1012
RIONET HEARING AID HB-71M
1
Cleared 510(K)
K
84
0871
BEHIND-THE-EAR HEARING AID 2000
1
Cleared 510(K)
K
84
0842
HEARING AID UNITRON UE8
1
Cleared 510(K)
K
84
0825
SERIES MR IN-THE-EAR CUSTOM HEARING AID
1
Cleared 510(K)
K
84
0559
IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
84
0479
BEHING-THE-EAR HEARING AID T-85D
1
Cleared 510(K)
K
84
0480
BEHIND THE EAR HEARING AID T-97
1
Cleared 510(K)
K
83
3773
CANAL HEARING AID
1
Cleared 510(K)
K
84
0359
POST-AURICULAR HEARING AID
1
Cleared 510(K)
K
83
4523
MODEL M410D HEARING AID
1
Cleared 510(K)
K
83
3926
HEARING AID
1
Cleared 510(K)
K
83
3803
OTICON, E26P
1
Cleared 510(K)
K
83
3775
BEHIND-THE-EAR HEARING AIDS T-87 &
1
Cleared 510(K)
K
83
3333
IN THE EAR HEARING AID OMNI 100
1
Cleared 510(K)
K
83
3152
METAVOX MV-1000 HEARING AID
1
Cleared 510(K)
K
83
3614
HEARING AID, UNITRON UT1
1
Cleared 510(K)
K
83
3615
HEARING AID UNITRON UI3
1
Cleared 510(K)
K
83
2633
INNOVATIVE HEARING CORP. #IHC 1000
1
Cleared 510(K)
K
83
2168
PERSONAL AMPLIFIER
1
Cleared 510(K)
K
83
3510
PANASONIC WH-50 HEARING AID
1
Cleared 510(K)
K
83
3451
TEL-STAR NUWAY & GENERIC E ASP-BP
1
Cleared 510(K)
K
83
3334
BEHIND THE EAR ASP-BB
1
Cleared 510(K)
K
83
3134
RIONET HEARING AID HB-345
1
Cleared 510(K)
K
83
3073
DAHLBERG #USS IN THE EAR HEARING AID
1
Cleared 510(K)
K
83
2751
BEHIND-THE-EAR SERIES 125
1
Cleared 510(K)
K
83
2701
HSI ELITE #EC CUSTOM CANAL HEAR-AID
1
Cleared 510(K)
K
83
2376
WIDEX HEARING AID MODEL L1
1
Cleared 510(K)
K
83
2326
BEHIND-THE-EAR #123 AGCI
1
Cleared 510(K)
K
83
2180
REXTON RX10, RX20-30 & 40
1
Cleared 510(K)
K
83
1883
HEARING AID UNITRON #UE8-D
1
Cleared 510(K)
K
83
1129
HEARCO C
1
Cleared 510(K)
K
83
2081
PHONIC EAR PE 845PPC-D
1
Cleared 510(K)
K
83
2129
HEARING AID G3H & G3T
1
Cleared 510(K)
K
83
0790
PERSONAL AMPLIFIER MODULE
1
Cleared 510(K)
K
83
1721
RIONET HEARING AID -AND/OR RION
1
Cleared 510(K)
K
83
0960
CUSTOM IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
83
1217
MODEL BERNAFON T-86
1
Cleared 510(K)
K
83
1197
MODEL 343D HEARING AID
1
Cleared 510(K)
K
83
0465
WIDEX HEARING AID #G2H & G2T
1
Cleared 510(K)
K
82
3588
PERSONAL ROMEAR
1
Cleared 510(K)
K
82
3788
MECON I
1
Cleared 510(K)
K
83
0236
RIONET HEARING AID
1
Cleared 510(K)
K
83
0436
OTICON, E-27P
1
Cleared 510(K)
K
83
0435
OTICON, E25P
1
Cleared 510(K)
K
83
0459
BEHIND THE EAR HEARING AID OMNI #OS
1
Cleared 510(K)
K
83
0402
HEARING AID, #UE7-D
1
Cleared 510(K)
K
83
0303
800 BLUE
1
Cleared 510(K)
K
83
0098
PHONIC EAR
1
Cleared 510(K)
K
82
3067
MODEL F1 HEARING AID
1
Cleared 510(K)
K
82
3847
RIONET HEARING AID HB-69CI
1
Cleared 510(K)
K
82
3803
RIONET HEARING AID HB-32P
1
Cleared 510(K)
K
82
3089
RCI EARMATE
1
Cleared 510(K)
K
82
3244
TECH. CLARATRON & INDUSTRIAL AMPLIFIER
1
Cleared 510(K)
K
82
3178
TEL-STAR NU-WAY & GENERIC E
1
Cleared 510(K)
K
82
3073
101M IN-THE-EAR
1
Cleared 510(K)
K
82
3669
HEARING AID UNITRON #UE4-H
1
Cleared 510(K)
K
82
3531
BEHIND-THE-EAR HEARING AID #8003
1
Cleared 510(K)
K
82
3384
HEARING AID HB-72 RIONET
1
Cleared 510(K)
K
82
3383
HEARING AID HB-33 RIONET
1
Cleared 510(K)
K
82
3468
MODEL H 37E
1
Cleared 510(K)
K
82
3460
MODELS G6H, G6T, G1H & G1T
1
Cleared 510(K)
K
82
3431
HEARING AID #G6H & G6T
1
Cleared 510(K)
K
82
3366
HEARING AID UE-10-H
1
Cleared 510(K)
K
82
3285
MODEL WHO1 HEARING AID
1
Cleared 510(K)
K
82
3365
HEARING AID UE-10
1
Cleared 510(K)
K
82
2805
HEARING AID, UNITRON MODEL UE7
1
Cleared 510(K)
K
82
2779
PHONIC EAR-PE 845-PPC
1
Cleared 510(K)
K
82
2579
BOSCH STAR 66F-SP HEARING AID
1
Cleared 510(K)
K
82
2655
BEHIND-THE-EAR MODEL 115 V AGC O W
1
Cleared 510(K)
K
82
2619
BEHIND-THE-EAR MODEL 115PPPCW
1
Cleared 510(K)
K
82
2506
HEARING AID, UNITRON UE3-D/DN
1
Cleared 510(K)
K
82
2387
BEHIND-THE-EAR MODEL SERIES 123
1
Cleared 510(K)
K
82
1987
EARETTE HEARING AID OPTICON MODEL E28P
1
Cleared 510(K)
K
82
1991
DANAVOS CUSTOM EAR
1
Cleared 510(K)
K
82
2163
ENT RETRACTORS
1
Cleared 510(K)
K
82
1972
HEARING AID VARIOUS MODELS
1
Cleared 510(K)
K
82
1900
HEARING AID, UNITRON MODEL UE5
1
Cleared 510(K)
K
82
1899
HEARING AID, UNITRON MODELS UE3/3-N
1
Cleared 510(K)
K
82
1760
SERIES M PUSH-PULL INPUT COMPRESSION
1
Cleared 510(K)
K
82
1550
MODEL AH BEHING-THE-EAR-HEARING AID
1
Cleared 510(K)
K
82
1447
MODEL BERUAFON T85 & T95
1
Cleared 510(K)
K
82
1390
CUSTOM, IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
82
1325
OTICON
1
Cleared 510(K)
K
82
1165
SONIC MODEL 8711 HEARING AID
1
Cleared 510(K)
K
82
1132
MODEL 28C HEAPING AID
1
Cleared 510(K)
K
82
1042
MODEL IM9
1
Cleared 510(K)
K
82
0993
AUDIO-ADI, AA SERIES
1
Cleared 510(K)
K
82
0833
AUDICRAFT VIP HEARING AID
1
Cleared 510(K)
K
82
0656
RIONET HEARING AID HA-57
1
Cleared 510(K)
K
82
0185
RELINER FOR HEARING AID EARMOLDS
1
Cleared 510(K)
K
82
0488
CHAMPION - HEARING AID
1
Cleared 510(K)
K
82
0445
HEARING AID
1
Cleared 510(K)
K
82
0425
OTOMET MODEL M-9 HEARING INSTRUMENT
1
Cleared 510(K)
K
82
0398
DAHLBERG HEARING AID MODEL AL
1
Cleared 510(K)
K
82
0349
RIONET HEARING AID HB-71H
1
Cleared 510(K)
K
82
0348
RIONET HEARING AID HB-69AS
1
Cleared 510(K)
K
82
0350
RIONET HEARING AID HB-71S
1
Cleared 510(K)
K
82
0172
PHONIC EAR MODEL PE 810S
1
Cleared 510(K)
K
82
0148
MODEL 343 HEARING AID
1
Cleared 510(K)
K
82
0041
BOSCH TOP STAR III
1
Cleared 510(K)
K
81
3330
POST-AURICULAR HEARING AID MODEL S-101
1
Cleared 510(K)
K
81
3329
POST-AURICULAR HEARING AID MODEL P-101
1
Cleared 510(K)
K
81
3583
PHONIC EAR MODEL PE805CD
1
Cleared 510(K)
K
81
3546
RIONET HEARING AID HI-62
1
Cleared 510(K)
K
81
3344
POST-AURICULAR HEARING AID MODEL ASP-103
1
Cleared 510(K)
K
81
3316
CUSTOM-IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
81
3206
HEARING AID CUSTOM ITE
1
Cleared 510(K)
K
81
3229
HEARING AID MODEL UE9-R
1
Cleared 510(K)
K
81
3249
HELP-MATE
1
Cleared 510(K)
K
81
2939
IN-THE-EAR MODEL 101M
1
Cleared 510(K)
K
81
2938
IN-THE-EAR MODEL 821
1
Cleared 510(K)
K
81
2937
BEHIND-THE-EAR MODEL 115
1
Cleared 510(K)
K
81
2578
ELEGANCE
1
Cleared 510(K)
K
81
1988
EAGLE I HEARING AID
1
Cleared 510(K)
K
81
1719
CUSTOM IN-THE-EAR HEARING AID
1
Cleared 510(K)
K
81
1751
FINETONE MODEL VI HEARING AID
1
Cleared 510(K)
K
81
1578
DAHLBERG MODEL AP HEARING AID
1
Cleared 510(K)
K
81
1031
TELESONIC & ARCON
1
Cleared 510(K)
K
81
1530
RIONET HEARING AID HB 69 T
1
Cleared 510(K)
K
81
1531
RIONET HEARING AID HB-69
1
Cleared 510(K)
K
81
1529
RIONET HEARING AID HB-69S
1
Cleared 510(K)
K
81
1522
RE-HP SERIES HEARING AIDS
1
Cleared 510(K)
K
81
1344
BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
81
1286
HEARING AID MODEL E1-PL
1
Cleared 510(K)
K
81
1285
HEARING AID MODEL E1-P
1
Cleared 510(K)
K
81
1158
OMNI
1
Cleared 510(K)
K
81
1226
DAHLBERG MODEL AM
1
Cleared 510(K)
K
81
1174
HEARING AID, UNITRON MODEL C5-H
1
Cleared 510(K)
K
81
0986
EARETTE HEARING AID OTICON #E25F
1
Cleared 510(K)
K
81
0987
EARETTE HEARING AID OTICON #E27F
1
Cleared 510(K)
K
81
0577
POWER SONIC
1
Cleared 510(K)
K
81
0347
BOSCH STAR 66F SUPER EARLEVEL AID
1
Cleared 510(K)
K
81
0610
EARETTE HEARING AID OTICON #E27
1
Cleared 510(K)
K
81
0576
EARETTE HEARING AID(BEHING THE EAR)
1
Cleared 510(K)
K
81
0389
EARETTE HEARING AID SEARS MODEL 8053
1
Cleared 510(K)
K
81
0030
POST-AURICULAR HEARING AID (#PE830)
1
Cleared 510(K)
K
80
2859
BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
80
2382
SONIC EAR
1
Cleared 510(K)
K
80
2597
TELESONIC ARCON & SOUNDEX ASP 101
1
Cleared 510(K)
K
80
2596
TELESONIC, ARCON & SOUNDEX ASP 102
1
Cleared 510(K)
K
80
2510
DAHLBERG HEARING AID MODEL AI
1
Cleared 510(K)
K
80
2324
E1 SERIES HEARING AID
1
Cleared 510(K)
K
80
2306
WIDEX HEARING AID #'S A18+T & A18+H
1
Cleared 510(K)
K
80
2307
WIDEX HEARING AID #'S A12+T & A12+H
1
Cleared 510(K)
K
80
2053
RIONET HEARING AID HB-69C
1
Cleared 510(K)
K
80
1958
RIONET HEARING AID HB-70H
1
Cleared 510(K)
K
80
1692
RIONET HEARING AID AND/OR RION #HB-70
1
Cleared 510(K)
K
80
1556
RIONET HEARING AID HB-66
1
Cleared 510(K)
K
80
1448
OTICON MODEL E17P EARETTE HEARING AID
1
Cleared 510(K)
K
80
1367
MODEL 336B HEARING AID
1
Cleared 510(K)
K
80
1230
HEARING AID, UNITRON MODEL C4-55
1
Cleared 510(K)
K
80
1062
BEHIND-THE-EAR HEARING AID SERIES G
1
Cleared 510(K)
K
80
0940
AUDIONICS PB MAX HEARING AID
1
Cleared 510(K)
K
80
0779
OMNITON MT80-A BODY HEARING AID
1
Cleared 510(K)
K
80
1115
DAHLBERG HEARING AID MODEL MEL
1
Cleared 510(K)
K
80
1114
DAHLBERG HEARING AID MODEL MEH
1
Cleared 510(K)
K
80
1067
TELESONIC, GENERIC & SOUNDEX C-102
1
Cleared 510(K)
K
80
1066
TELESONIC, SOUNDEX & GENERIC V-101
1
Cleared 510(K)
K
80
1023
ASL CUSTOM IN-THE-EAR HEARING AID #L
1
Cleared 510(K)
K
80
1003
OTICON EARETTE HEARING AID #E17CF
1
Cleared 510(K)
K
80
1002
OTICON EARETTE HEARING AID #E17 HC
1
Cleared 510(K)
K
80
0945
RADIOEAR MODEL REI HEARING AID
1
Cleared 510(K)
K
80
0567
RADIOEAR MODEL RM-L & RM-C HEARING AID
1
Cleared 510(K)
K
80
0739
RIONET &/OR RION HEARING AID MODEL HA-82
1
Cleared 510(K)
K
80
0738
RIONET &/OR RION HEARING AID MOD. HB-67S
1
Cleared 510(K)
K
80
0447
SEARS ALL-IN-THE-EAR HEARING AID #8149HF
1
Cleared 510(K)
K
80
0446
SEARS ALL-IN-THE-EAR HEARING AID #8149
1
Cleared 510(K)
K
80
0571
DAHLBERG #AZ BEHIND THE EAR HEARING AID
1
Cleared 510(K)
K
80
0244
BEHIND EAR HEARING AID MODEL E24C1
1
Cleared 510(K)
K
80
0345
MODEL 795U BEHIND THE EAR HEARING AID
1
Cleared 510(K)
K
80
0332
RADIOEAR MODEL 2080 (HEARING AID)
1
Cleared 510(K)
K
80
0181
DAHLBERG # AF BEHING THE EAR HEARING/AID
1
Cleared 510(K)
K
80
0340
PHONIC EAR, MODEL 841L
1
Cleared 510(K)
K
80
0316
OTICON MODEL E19VF EARETTE HEARING AID
1
Cleared 510(K)
K
80
0283
OTICON MODEL E17VF EARETTE HEARING AID
1
Cleared 510(K)
K
80
0269
AUDIONICS PB MAX HEARING AID
1
Cleared 510(K)
K
80
0113
SEARS BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
80
0105
TELESONIC (HEARING AID)
1
Cleared 510(K)
K
80
0012
RIONET HEARING AID HA-61
1
Cleared 510(K)
K
80
0011
RIONET HEARING AID HE-71
1
Cleared 510(K)
K
79
2643
HEARING AID, MODELS DRI-35/DL1-35
1
Cleared 510(K)
K
79
2644
TELESONIC V-101
1
Cleared 510(K)
K
79
2389
WIDEX HEARING AID MODEL S10
1
Cleared 510(K)
K
79
2567
WIDEX HEARING AID MODEL 820
1
Cleared 510(K)
K
79
2464
MODEL 341H (HEARING AID)
1
Cleared 510(K)
K
79
2463
MODEL 339 TELECROS WIRELESS CROS
1
Cleared 510(K)
K
79
2462
MODEL 339 TELECROS WIRELESS BICROS
1
Cleared 510(K)
K
79
2506
RIONET HEARING AID HB-68L
1
Cleared 510(K)
K
79
2505
RIONET HEARING AID HB-32T
1
Cleared 510(K)
K
79
2334
BEHINDTHEEAR HEAR. AID MOD. 793U,M,UH,MH
1
Cleared 510(K)
K
79
2236
HEARING AID, UNITRON MODEL 905H
1
Cleared 510(K)
K
79
2237
HEARING AID, UNITRON MODEL 905W
1
Cleared 510(K)
K
79
2278
DAHLBERG MODEL AE HIGH FREQUENCY / AID
1
Cleared 510(K)
K
79
2198
SERIES S (BEHIND-THE-EAR-HEARING AID)
1
Cleared 510(K)
K
79
1739
RIONET HEARING AID MODEL HA-55
1
Cleared 510(K)
K
79
1881
RIONET HEARING AID HB-65T
1
Cleared 510(K)
K
79
1880
RIONET HEARING AID HB-64T
1
Cleared 510(K)
K
79
1878
RIONET HEARING AID HB-64C
1
Cleared 510(K)
K
79
1745
MODEL H44-80 BEHIND THE EAR HEARING
1
Cleared 510(K)
K
79
1876
RIONET HEARING AID HB-32
1
Cleared 510(K)
K
79
1884
RIONET HEARING AID HI-60
1
Cleared 510(K)
K
79
1882
RIONET HEARING AID HB-67T
1
Cleared 510(K)
K
79
1877
RIONET HEARING AID HB-32H
1
Cleared 510(K)
K
79
1879
RIONET HEARING AID HB-64S
1
Cleared 510(K)
K
79
1600
MODEL 33A HEARING AIDS
1
Cleared 510(K)
K
79
1601
MODEL 336A HEARING AIDS
1
Cleared 510(K)
K
79
1599
MODEL 33DA HEARING AIDS
1
Cleared 510(K)
K
79
1310
DAHLBERG HEARING AID MODEL GC
1
Cleared 510(K)
K
79
1506
MODEL 344
1
Cleared 510(K)
K
79
1311
DAHLBERG HEARING AID MODEL UN
1
Cleared 510(K)
K
79
1356
EARETTE HEARING AID
1
Cleared 510(K)
K
79
1203
MODEL SE-1 EYEGLASS HEARING AID
1
Cleared 510(K)
K
79
1126
MODEL CE-DM-II HEARING INSTRUMENT
1
Cleared 510(K)
K
79
0870
MODEL H63, BEHIND-THE-EAR
1
Cleared 510(K)
K
79
0737
HSI MODEL C. CUSTOM IN-THE-EAR HEAR/AID
1
Cleared 510(K)
K
79
0745
_MODEL WC-1 BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
79
0727
BEHIND-THE-EAR, MODEL H37D
1
Cleared 510(K)
K
79
0726
BEHIND-THE-EAR HEARING INSTRUMENT, H54
1
Cleared 510(K)
K
79
0700
BEHIND-THE-EAR HEARING INSTRUMENT, H56
1
Cleared 510(K)
K
79
0697
MODEL H58-BEHIND-THE-EAR HEARING INSTR.
1
Cleared 510(K)
K
79
0651
MODEL WC-3 HEARING AID
1
Cleared 510(K)
K
79
0539
HEARING AID DANAVOX 775V
1
Cleared 510(K)
K
79
0515
BEHIND-THE-EAR HEARING AID
1
Cleared 510(K)
K
79
0482
MODEL 4107-2S, HEARING AID
1
Cleared 510(K)
K
79
0412
MODEL 337E HEARING AID
1
Cleared 510(K)
K
79
0355
MODEL 342D HEARING AIDS
1
Cleared 510(K)
K
79
0354
MODEL 342 HEARING AIDS
1
Cleared 510(K)
K
79
0270
HEARING AID MODEL 8143
1
Cleared 510(K)
K
79
0301
HEARING AID, OTICON I II H
1
Cleared 510(K)
K
79
0228
EARETTE HEARING AID
1
Cleared 510(K)
K
79
0094
MODULE PERSONAL EAR (COMPRESSION)
1
Cleared 510(K)
K
79
0095
MODULE PERSONAL EAR (DELUXE)
1
Cleared 510(K)
K
79
0093
MODULE PERSONAL EAR (SUPER)
1
Cleared 510(K)
K
78
2121
HEARING AID, MODEL GB
1
Cleared 510(K)
K
78
2122
HEARING AID, MODEL AA
1
Cleared 510(K)
K
78
2053
HEARING AID, POST-AURICULAR
1
Cleared 510(K)
K
78
1881
HEARING AID, MODEL 781
1
Cleared 510(K)
K
78
1663
HEARING AID, ITE MODULAR MODEL I, II, V
1
Cleared 510(K)
K
78
1595
BODY-WORN HEARING AID, MODEL 787PP
1
Cleared 510(K)
K
78
1596
HEARING AID, MODEL 775 PP/AGC
1
Cleared 510(K)
K
78
1513
HEARING AID, UNITRON MODEL 960PL
1
Cleared 510(K)
K
78
1502
HEARING AID, UNITRON MODEL 761P
1
Cleared 510(K)
K
78
1458
RADIOEAR RE SERIES HEARING AIDS
1
Cleared 510(K)
K
78
1434
HEARING AID, UNITRON MODEL 975
1
Cleared 510(K)
K
78
1439
HEARING AID, UNITRON MODEL 958
1
Cleared 510(K)
K
78
1212
HEARING AID, MODEL 783DU
1
Cleared 510(K)
K
78
1094
HEARING AID, EYEGLASS
1
Cleared 510(K)
K
78
1096
HEARING AID, EYEGLASS, B-12
1
Cleared 510(K)
K
78
1095
HEARING AID, BEHIND THE EAR
1
Cleared 510(K)
K
78
1033
HEARING AID
1
Cleared 510(K)
K
78
0917
PRIMO CE (BEHIND THE EAR)
1
Cleared 510(K)
K
78
0922
UM VII (BEHIND THE EAR)
1
Cleared 510(K)
K
78
0921
MM-CE DM (BEHIND THE EAR)
1
Cleared 510(K)
K
78
0920
MM-CE 11 (BEHIND THE EAR)
1
Cleared 510(K)
K
78
0919
M25 PP (BEHIND THE EAR)
1
Cleared 510(K)
K
78
0918
PRIMO CEDM (BEHIND THE EAR)
1
Cleared 510(K)
K
78
0916
780 UE (BEHIND THE EAR)
1
Cleared 510(K)
K
78
0915
780 SE (BEHIND THE EAR)
1
Cleared 510(K)
K
78
0914
PM 25 PP (BODY AID)
1
Cleared 510(K)
K
78
0820
HEARING AID MODEL 8148
1
Cleared 510(K)
K
78
0822
HEARING AID MODEL 8160U
1
Cleared 510(K)
K
78
0821
HEARING AID MODEL 8160H
1
Cleared 510(K)
K
78
0694
HEARING AID BATTERY CHARGER
1
Cleared 510(K)
K
78
0699
EARETTE HEARING AID
1
Cleared 510(K)
K
78
0667
HEARING AID-MODEL 2010
1
Cleared 510(K)
K
78
0669
HEATING AIDS-MODEL C78A & C78B
1
Cleared 510(K)
K
78
0654
HEARING AID, EARETTE
1
Cleared 510(K)
K
78
0459
CLEARTONE MODEL-1 & 2 HEARING AIDS
1
Cleared 510(K)
K
78
0363
PHONIC EAR
1
Cleared 510(K)
K
78
0309
IN-THE-EAR HEARING AID, MODEL CE-3
1
Cleared 510(K)
K
78
0197
HEARING AID, BODY WORN
1
Cleared 510(K)
K
78
0241
COMPRESSION MULTISONIC
1
Cleared 510(K)
K
78
0067
HEARING AID, BEHIND-THE-EAR
1
Cleared 510(K)
K
77
2201
HEARING AID, BODY TYPE, MODEL H
1
Cleared 510(K)
K
77
2100
HEARING AID-MODEL CE-2
1
Cleared 510(K)
K
77
2101
HEARING AID-MODEL PE-1
1
Cleared 510(K)
K
77
1762
MODULAR HEARING DEVICE, MODEL S291
1
Cleared 510(K)
K
77
1607
HEARING AID MODEL 775
1
Cleared 510(K)
K
77
1356
POST-AURICULAR HEARING AID HC 880
1
Cleared 510(K)
K
77
1069
MULTISONIC (SUPER) CODE TSM
1
Cleared 510(K)
K
77
1029
MULTISONIC (DELUXE) CODE TDM
1
Cleared 510(K)
K
77
0960
HEARING AID, SERIES R
1
Cleared 510(K)
K
77
0885
HEARING AID, SERIES K-BEHIND-THE-EAR
1
Cleared 510(K)
K
77
0688
HEARING AID MODEL F8H ANL F8T
1
Cleared 510(K)
K
77
0689
HEARING AID MODEL A8H AND A8T
1
Cleared 510(K)
K
77
0373
HEARING AID, MAICO DB-POWER
1
Cleared 510(K)
K
77
0360
HEARING AID, MAICO DM MARK 180
1
Cleared 510(K)
K
77
0321
PERCEPTOR
1
Cleared 510(K)
K
77
0308
HEARING AID, DM IROS DIRECTIONAL
1
Cleared 510(K)
K
77
0309
HEARING AID, DM IROS
1
Cleared 510(K)
K
76
1223
WIDEX HEARING AID MODEL F8
1
Cleared 510(K)
K
76
1216
HEARING AIDS (MODEL E-552 S-712)
1
Cleared 510(K)
K
76
1103
WIDEX HEARING AID MODEL F7H & F7T
1
Cleared 510(K)
K
76
0996
HEARING AID (MODEL 695D, 905 & 960P)
1
Cleared 510(K)
K
76
0887
COMPRESSION ADJUSTRETTE
1
Cleared 510(K)
K
76
0609
EYEGLASS HEARING AID
1
Cleared 510(K)
K
76
0244
RADIOEAR, PERSONAL
1
Cleared 510(K)
K
76
0215
HEARING AID, S-522 FM
1
Cleared 510(K)
ESE
Larynx, Artificial (Battery-Powered)
1
Product Code
ESH
Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
2
Product Code
ESX
Tack, Sacculotomy (Cody Tack)
2
Product Code
ESZ
Tube, Shunt, Endolymphatic
2
Product Code
ETA
Replacement, Ossicular Prosthesis, Total
2
Product Code
ETB
Prosthesis, Partial Ossicular Replacement
2
Product Code
ETC
Mold, Middle-Ear
2
Product Code
ETD
Tube, Tympanostomy
2
Product Code
ETW
Calibrator, Hearing Aid / Earphone And Analysis Systems
2
Product Code
EWL
Prosthesis, Laryngeal (Taub)
2
Product Code
FWN
Prosthesis, Larynx (Stents And Keels)
2
Product Code
JAZ
Prosthesis, Facial, Mandibular Implant
2
Product Code
JOF
Polymer, Ent Synthetic, Porous Polyethylene
2
Product Code
JXS
Block, Cutting, Ent, Sterile
1
Product Code
JXT
Crimper, Wire, Ent, Sterile
1
Product Code
JXW
Die, Wire Bending, Ent, Sterile
1
Product Code
JXX
Forceps, Wire Closure, Ent, Sterile
1
Product Code
JXY
Jig, Piston Cutting, Ent, Sterile
1
Product Code
JXZ
Punch, Gelfoam, Sterile
1
Product Code
JYA
Scissors, Wire Cutting, Ent, Sterile
1
Product Code
JYB
Vise, Ossicular Finger, Sterile
1
Product Code
KHJ
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
2
Product Code
KHL
Hearing Aid, Master
2
Product Code
KLW
Masker, Tinnitus
2
Product Code
KLZ
Tube, Shunt, Endolymphatic With Valve
2
Product Code
KQL
Tube, Tympanostomy With Semi-Permeable Membrane
2
Product Code
LBL
Tube, Tympanostomy, Porous Polyethylene
2
Product Code
LBM
Porous Polyethylene Ossicular Replacement
2
Product Code
LBN
Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene
2
Product Code
LBP
Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material
2
Product Code
LDG
Kit, Earmold, Impression
1
Product Code
LRB
Face Plate Hearing Aid
1
Product Code
LRE
Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile
1
Product Code
LWF
Dilator, Nasal
1
Product Code
LXB
Hearing Aid, Bone Conduction
2
Product Code
LZI
Device, Assistive Listening
2
Product Code
MAH
Hearing Aid, Bone Conduction, Implanted
2
Product Code
MCK
Device, Voice Amplification
2
Product Code
MIX
System, Vocal Cord Medialization
2
Product Code
NHB
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
2
Product Code
NIX
Hearing Aid, Air Conduction, Transcutaneous System
2
Product Code
NNN
Crimper, Wire, Ent, Non-Sterile
1
Product Code
NNO
Jig, Piston Cutting, Ent, Non-Sterile
1
Product Code
NNP
Die, Wire Bending, Ent, Non-Sterile
1
Product Code
NNQ
Forceps, Wire Closure, Ent, Non-Sterile
1
Product Code
NNR
Block, Cutting, Ent, Non-Sterile
1
Product Code
NNS
Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile
1
Product Code
NNT
Punch, Gelfoam, Non-Sterile
1
Product Code
NNU
Scissors, Wire Cutting, Ent, Non-Sterile
1
Product Code
NNV
Vise, Ossicular Finger, Non-Sterile
1
Product Code
OGS
Myringotomy Procedure Kit
2
Product Code
OSM
Hearing Aid, Air Conduction With Wireless Technology
2
Product Code
PFO
Active Implantable Bone Conduction Hearing System
2
Product Code
PLK
Tympanic Membrane Direct Contact Hearing Aid
2
Product Code
QDD
Self-Fitting Air-Conduction Hearing Aid
2
Product Code
QUF
Hearing Aid, Air-Conduction, Over The Counter
1
Product Code
QUG
Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
2
Product Code
QUH
Self-Fitting Air-Conduction Hearing Aid, Over The Counter
2
Product Code
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 13 December 2024 at 11:05 pm
EN
/
subpart-d—prosthetic-devices
/
ESD
/
K900675
View Source
PHONAK ITE 8000, 7000, 6000 ITE HEARING AID
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K900675
510(k) Type
Traditional
Applicant
PHONAK, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/23/1990
Days to Decision
100 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Miscellaneous
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
EPF
Hearing Aid, Group And Auditory Trainer
NEA
Cement, Ear, Nose And Throat
ESD
Hearing Aid, Air Conduction
K
23
2999
Lyric4 Hearing Aid
K
13
0790
LYRIC2
K
08
1136
LYRIC HEARING AID
K
02
1867
INSOUND XT SERIES HEARING AID
K
00
3558
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
K
98
4518
SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL
K
97
4751
TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC
K
97
4242
ARGOSY PROGRAMMABLE ONQUE
K
97
3880
SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM
K
97
4211
OPUS 2 - FULL CONCHA SERIES - ITE
K
97
4152
OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)
K
97
4069
OPUS 2 - CANAL SERIES (ITC)
K
97
4338
UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)
K
97
4339
UNITRON MODEL SOUND F/XD PROGRAMMABLE
K
97
4340
UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE
K
97
4257
RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)
K
97
4129
HI-69E, HI-69N, HI-69P
K
97
4081
RESOUND STEALTH CIC
K
97
3927
HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL
K
97
3861
FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48
K
97
3972
PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER)
K
97
3886
OTICON DIGISOUND COMPACT
K
97
3885
OTICON DIGISOUND ITE
K
97
3665
MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER
K
97
3846
AIR CONDUCTION HEARING AID
K
97
3948
DUALINE 100 BTE
K
97
3579
AM SERIES HEARING AID
K
97
3043
MODEL C-1 HEARING AID
K
97
2818
D72 DIGITAL
K
97
3376
LORI/LORI, LORI-S (LORI STOCK AID)
K
97
3266
Z DEQ-II
K
97
2776
DRY & STORE
K
97
2998
PRISMA
K
97
2039
NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC)
K
97
2106
PHONAK NOVO FORTE E3
K
97
2058
LORIPRO, LORIPRO II
K
97
1852
AIR CONDUCTION HAEARING AIDS
K
97
1845
HEARTLAND TECHNOLOGIES, ITE, ITC, CIC
K
97
1807
IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL
K
97
2755
V-12 LONG LIFE 675 HEARING AID
K
97
2105
PHONAK EPICA
K
97
2550
AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC
K
97
2552
AUDIFON H20 PC/AUDIFON H32 PP
K
97
2097
PHONAK MICROZOOM P 2
K
97
2373
OVATION HDP
K
97
2542
JAZZ PP AGC-O, JAZZ PP
K
97
2543
TWIST PPAGC-1, TWIST PP
K
97
2431
MERIDIAN DSP
K
97
2344
MIRACLE-EAR DIGITAL BTE
K
97
2346
MIRACLE-EAR ITE DIGITAL
K
97
2345
DAHLBERG/MIRACLE-EAR
K
97
1298
BETTER HEARING, INC. MODEL L-1 HEARING AID
K
97
1699
ARGOSY DYNAMEQ
K
97
1605
RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION
K
97
1296
TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05
K
97
1031
AUDALLION III HEARING SYSTEM
K
97
1032
DANAVOX MODELS 163/162 BTE
K
97
1399
AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC
K
97
1158
DUALINE 400 CIC
K
97
1804
PHILIPS S1694, S1695
K
97
1693
RIONET HB-79P
K
97
1535
WIDEX SENSO DIGITAL (MINI CANAL)
K
97
1299
SCIENTIFIC PLASTICS MODEL SP
K
97
0939
VISTA V-38 CIC
K
97
0880
POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN
K
97
0828
UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMER
K
97
0692
UNITRON MODEL SOUND F/X CIC
K
97
0952
PRECISE IMPRESSION KIT
K
97
0519
UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)
K
96
4898
IN THE EAR HEARING AID
K
97
0262
MULTI-CHANNEL COMPRESSION BTE (SD)
K
97
0215
AUDALLION II HEARING SYSTEM
K
97
0537
REXTON MODEL 48 AND 49PP
K
97
0904
WIDEX SENSO DIGITAL (CIC)
K
96
5254
WIDEX MODEL SENSO DIGITAL (C9)
K
97
0430
ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCI
K
97
0057
AHS OMEGA SP
K
96
4657
SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF
K
96
4245
PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS
K
96
4419
MIRACLE - EAR (ITE/ITC/CIC)
K
96
5049
DAHLBERG (A-554)
K
96
5057
AUDIOTONE (A554H)
K
96
5063
AUDIOTONE (A-552)
K
96
5218
SENSO DIGITAL (C18)
K
96
5088
M11 SERIES: M11, M11M
K
96
4680
COMFORTAID HEARING AID
K
96
4639
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II
K
96
4816
AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR
K
96
4669
MIRACLE-EAR OR AUDIOTONE
K
96
4794
DAHLBERG K-AMP BTE
K
96
4683
DIGIFOCUS ITE
K
96
4603
ARTICULAR HEARING AIDS
K
96
3877
AHS OMEGA CONCEPT
K
96
3878
AHS OMEGA HF
K
96
3958
IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT
K
96
4035
PHONAK MICROLINK, PERSONAL FM RECEIVER
K
96
4557
RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION
K
96
4530
DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT
K
96
4511
UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4)
K
96
4504
UNITRON MODEL ICON AOHPL +4
K