Hearing Aid, Air-Conduction, Prescription
FDA product code ESD · Class I (low risk) · 21 CFR 874.3300 · Ear, Nose, Throat
An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is a prescription hearing aid.
1,367510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Unitron Industries, Inc. 69
- Miracle-Ear, Inc. 64
- Electone, Inc. 63
- Oticon Corp. 63
- Widex Hearing Aid Co., Inc. 51
- Rion Acoustic Instruments, Inc. 47
- Telex Communications, Inc. 39
- Starkey Laboratories, Inc. 39
- Phonak, Inc. 37
- Beltone Electronics Corp. 36
- Siemens Hearing Instruments, Inc. 36
- Qualitone 34
- Resound Corp. 33
- Authorized Hearing Systems, Inc. 31
- Maico Hearing Instruments, Inc. 31
- Dahlberg Electronics, Inc. 31
- Danavox, Inc. 25
- Argosy Electronics 24
- Miracle-Ear/Dahlberg, Inc. 22
- Rexton, Inc. 21
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232999 | Lyric4 Hearing AidESD · Traditional | Sonova AG | 04/11/2024SE |
| K130790 | LYRIC2ESD · Traditional | Phonak, LLC | 06/27/2013SE |
| K081136 | Lyric Hearing AidESD · Traditional | Insound Medical, Inc. | 05/08/2008SE |
| K021867 | Insound XT Series Hearing AidESD · Traditional | Insound Medical, Inc. | 11/19/2002SE |
| K003558 | Tci Combi (Tinnitus Control Instrument Combination)ESD · Traditional | Siemens Hearing Instruments, Inc. | 04/24/2001SE |
| K984518 | Sonic Innovations Completely-In-The-Canal DSP Hearing Aid with Soft ShellESD · Traditional | Sonic Innovations, Inc. | 03/12/1999SE |
| K974751 | Tranquil Tri-Oe, Tranquil Tri-Coe, Tranquil Tri-CicESD · Traditional | General Hearing Instruments, Inc. | 03/06/1998SE |
| K974242 | Argosy Programmable OnqueESD · Traditional | Argosy Electronics | 01/20/1998SE |
| K973880 | Sonix Hearing Aid Fitting and Programming SystemESD · Traditional | Sonix Technologies, Inc. | 01/12/1998SE |
| K974211 | Opus 2 - Full Concha Series - IteESD · Traditional | Bernafon-Maico, Inc. | 12/15/1997SE |
| K974152 | Opus 2 - Completely-In-Canal Series (Cic)ESD · Traditional | Bernafon-Maico, Inc. | 12/15/1997SE |
| K974069 | Opus 2 - Canal Series (Itc)ESD · Traditional | Bernafon-Maico, Inc. | 12/15/1997SE |
| K974340 | Unitron Model Sound F/Xp Programmable Mini BteESD · Traditional | Unitron Industries, Inc. | 12/12/1997SE |
| K974339 | Unitron Model Sound F/Xd ProgrammableESD · Traditional | Unitron Industries, Inc. | 12/12/1997SE |
| K974338 | Unitron Model F/X Programmable (Mini Bte)ESD · Traditional | Unitron Industries, Inc. | 12/12/1997SE |
| K974257 | Resound Digital 2000-BT W/Digital 2000-DF (Digital Programmer)ESD · Traditional | Resound Corp. | 12/12/1997SE |
| K974129 | HI-69E, HI-69N, HI-69PESD · Traditional | Rockwin Corp. | 12/12/1997SE |
| K974081 | Resound Stealth CicESD · Traditional | Resound Corp. | 12/12/1997SE |
| K973927 | Hyunjae Corporation - Nusil Earmold Impression MaterialESD · Traditional | Hyunjae Corp. | 12/11/1997SE |
| K973861 | Futura 67M, 68M, MEGAPOWERMP97, Integra 70,71,72,73, Supra 51,52, Supra 56,57,58,59…ESD · Traditional | Magnatone Hearing Aid Corp. | 11/19/1997SE |
| K973972 | Perfect Ear/ Mini-Canal/ Pe-M, Pe-Ml, Pe-Md), Perfect Ear/ C.I.C./ (Pec, Pe-Cd) (with or…ESD · Traditional | Perfect Ear | 11/04/1997SE |
| K973886 | Oticon Digisound CompactESD · Traditional | Oticon, Inc. | 11/04/1997SE |
| K973885 | Oticon Digisound IteESD · Traditional | Oticon, Inc. | 11/04/1997SE |
| K973665 | Magnatone / Sterling/ ST; Magnatone/Db; Magnatone/ Liberty/ LB; Magnatone/ Pearl/Ph…ESD · Traditional | Magnatone Hearing Aid Corp. | 11/04/1997SE |
| K973846 | Air Conduction Hearing AidESD · Traditional | Baron Trading, Inc. | 10/29/1997SE |
| K973948 | Dualine 100 BteESD · Traditional | Bernafon-Maico, Inc. | 10/28/1997SE |
| K973579 | Am Series Hearing AidESD · Traditional | A & M Hearing, Ltd. | 10/28/1997SE |
| K973043 | Model C-1 Hearing AidESD · Traditional | Better Hearing, Inc. | 10/27/1997SE |
| K972818 | D72 DigitalESD · Traditional | Philips Hearing Instruments Co. | 10/17/1997SE |
| K973376 | Lori/Lori, Lori-S (Lori Stock Aid)ESD · Traditional | Lori Medical Laboratories, Inc. | 10/14/1997SE |
| K973266 | Z Deq-IiESD · Traditional | Electone, Inc. | 09/23/1997SE |
| K972776 | Dry & StoreESD · Traditional | Ear Technology Corp. | 09/08/1997SE |
| K972998 | PrismaESD · Traditional | Siemens Hearing Instruments, Inc. | 09/05/1997SE |
| K972039 | New Sound Hidden Aid Completely in Canal (Cic)ESD · Traditional | Nu-Sound | 08/25/1997SE |
| K972106 | Phonak Novo Forte E3ESD · Traditional | Phonak, Inc. | 08/15/1997SE |
| K972058 | Loripro, Loripro IIESD · Traditional | Lori Medical Laboratories, Inc. | 08/15/1997SE |
| K971852 | Air Conduction Haearing AidsESD · Traditional | Beltone Electronics Corp. | 08/15/1997SE |
| K971845 | Heartland Technologies, Ite, Itc, CicESD · Traditional | Sound Hearing Instruments, Inc. | 08/15/1997SE |
| K971807 | In the Ear, in the Canal, Completely in the CanalESD · Traditional | Hear-Right, Inc. | 08/07/1997SE |
| K972755 | V-12 Long Life 675 Hearing AidESD · Traditional | Vista Labs | 08/05/1997SE |
| K972105 | Phonak EpicaESD · Traditional | Phonak, Inc. | 08/01/1997SE |
| K972550 | Audifon H24 Agc/Audifon H25 Agc/Audifon H30 AgcESD · Traditional | Trutone | 07/31/1997SE |
| K972552 | Audifon H20 Pc/Audifon H32 PPESD · Traditional | Trutone | 07/30/1997SE |
| K972097 | Phonak Microzoom P 2ESD · Traditional | Phonak, Inc. | 07/30/1997SE |
| K972373 | Ovation HDPESD · Traditional | Orsonique, Inc. | 07/29/1997SE |
| K972543 | Twist PPAGC-1, Twist PPESD · Traditional | Trutone | 07/23/1997SE |
| K972542 | Jazz PP Agc-O, Jazz PPESD · Traditional | Trutone | 07/23/1997SE |
| K972431 | Meridian DSPESD · Traditional | Micro-Ear Technology, Inc. | 07/23/1997SE |
| K972346 | Miracle-Ear Ite DigitalESD · Traditional | Miracle-Ear, Inc. | 07/23/1997SE |
| K972345 | Dahlberg/Miracle-EarESD · Traditional | Miracle-Ear, Inc. | 07/23/1997SE |
| K972344 | Miracle-Ear Digital BteESD · Traditional | Miracle-Ear, Inc. | 07/23/1997SE |
| K971298 | Better Hearing, Inc. Model L-1 Hearing AidESD · Traditional | Better Hearing, Inc. | 07/23/1997SE |
| K971699 | Argosy DynameqESD · Traditional | Argosy Electronics | 07/03/1997SE |
| K971605 | Resound ED4 Personal Hearing System W/Remote Control OptionESD · Traditional | Resound Corp. | 07/03/1997SE |
| K971296 | Tondi, Models U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05ESD · Traditional | National Hearing Aid Dist., Inc. | 06/20/1997SE |
| K971032 | Danavox Models 163/162 BteESD · Traditional | Gn Danavox, Inc. | 06/17/1997SE |
| K971031 | Audallion III Hearing SystemESD · Traditional | Gn Danavox, Inc. | 06/17/1997SE |
| K971399 | Auris Ae, Auris TL, Auris HS, Auris Ac, Auris MM, Auris Coe, Auris CicESD · Traditional | General Hearing Instruments, Inc. | 06/13/1997SE |
| K971158 | Dualine 400 CicESD · Traditional | Bernafon-Maico, Inc. | 06/13/1997SE |
| K971804 | Philips S1694, S1695ESD · Traditional | Philips Hearing Instruments Co. | 06/06/1997SE |
| K971693 | Rionet HB-79PESD · Traditional | Authorized Hearing Systems, Inc. | 06/06/1997SE |
| K971535 | Widex Senso Digital (Mini Canal)ESD · Traditional | Widex Hearing Aid Co., Inc. | 06/06/1997SE |
| K971299 | Scientific Plastics Model SPESD · Traditional | Scientific Plastics, Inc. | 06/06/1997SE |
| K970939 | Vista V-38 CicESD · Traditional | Vista Labs | 06/06/1997SE |
| K970880 | Power D, Tru 5, Persona, Persona Choice, MeridianESD · Traditional | Micro-Ear Technology, Inc. | 06/06/1997SE |
| K970828 | Uhs Micronet Programmable Hearing Aids Models 901,902,903,906,909/PROGRAMMERESD · Traditional | United Hearing Systems, Inc. | 05/28/1997SE |
| K970692 | Unitron Model Sound F/X CicESD · Traditional | Unitron Industries, Inc. | 05/08/1997SE |
| K970952 | Precise Impression KitESD · Traditional | Starkey Laboratories, Inc. | 05/02/1997SE |
| K970519 | Unitron Model Sound F/X Programmable Ite (Sf/X Programmable)ESD · Traditional | Unitron Industries, Inc. | 04/24/1997SE |
| K964898 | In the Ear Hearing AidESD · Traditional | Keytone Hearing Laboratory | 04/21/1997SE |
| K970262 | Multi-Channel Compression Bte (SD)ESD · Traditional | Miracle-Ear, Inc. | 03/31/1997SE |
| K970215 | Audallion II Hearing SystemESD · Traditional | Resound Corp. | 03/31/1997SE |
| K970537 | Rexton Model 48 and 49PPESD · Traditional | Rexton, Inc. | 03/28/1997SE |
| K970904 | Widex Senso Digital (Cic)ESD · Traditional | Widex Hearing Aid Co., Inc. | 03/26/1997SE |
| K965254 | Widex Model Senso Digital (C9)ESD · Traditional | Widex Hearing Aid Co., Inc. | 03/12/1997SE |
| K970430 | Adaptive Compression - Class D/ Class D AgciESD · Traditional | Midwest City Hearing Aid Center | 03/11/1997SE |
| K970057 | Ahs Omega SPESD · Traditional | Authorized Hearing Systems, Inc. | 02/26/1997SE |
| K964657 | Super K-Amp, Ez-Compression, Trim-Pro, Hf-Pro, Enviro-Pro, Compression-Pro, Compression…ESD · Traditional | Micro-Ear Technology, Inc. | 02/11/1997SE |
| K964419 | Miracle - Ear (Ite/Itc/Cic)ESD · Traditional | Miracle-Ear, Inc. | 02/04/1997SE |
| K964245 | Precise, Tynmpanette, and Xacto Impression KitsESD · Traditional | Starkey Laboratories, Inc. | 02/04/1997SE |
| K965063 | Audiotone (A-552)ESD · Traditional | Miracle-Ear, Inc. | 01/27/1997SE |
| K965057 | Audiotone (A554H)ESD · Traditional | Miracle-Ear, Inc. | 01/27/1997SE |
| K965049 | Dahlberg (A-554)ESD · Traditional | Miracle-Ear, Inc. | 01/27/1997SE |
| K965218 | Senso Digital (C18)ESD · Traditional | Widex Hearing Aid Co., Inc. | 01/24/1997SE |
| K965088 | M11 Series: M11, M11MESD · Traditional | Philips Hearing Instruments Co. | 01/24/1997SE |
| K964680 | Comfortaid Hearing AidESD · Traditional | Ethical Hearing Instruments | 01/24/1997SE |
| K964639 | Telex In-The-Ear Custom Hearing Aid with Threshold Compression-IiESD · Traditional | Telex Communications, Inc. | 01/21/1997SE |
| K964816 | Audina 153 Behind the Ear and Audina 158 Behind the EarESD · Traditional | Audina Hearing Instrument | 01/17/1997SE |
| K964669 | Miracle-Ear or AudiotoneESD · Traditional | Miracle-Ear, Inc. | 12/26/1996SE |
| K964794 | Dahlberg K-Amp BteESD · Traditional | Miracle-Ear, Inc. | 12/23/1996SE |
| K964683 | Digifocus IteESD · Traditional | Oticon, Inc. | 12/12/1996SE |
| K964603 | Articular Hearing AidsESD · Traditional | Decibel Instruments, Inc. | 12/06/1996SE |
| K963878 | Ahs Omega HFESD · Traditional | Authorized Hearing Systems, Inc. | 12/06/1996SE |
| K963877 | Ahs Omega ConceptESD · Traditional | Authorized Hearing Systems, Inc. | 12/06/1996SE |
| K963958 | Impress, Perfecta, Acu-Form, and AcufitESD · Traditional | Beltone Electronics Corp. | 12/05/1996SE |
| K964035 | Phonak Microlink, Personal FM ReceiverESD · Traditional | Phonak, Inc. | 12/04/1996SE |
| K964557 | Resound BT4 Personal Hearing System W/Remote Control OptionESD · Traditional | Resound Corp. | 11/27/1996SE |
| K964530 | Dahlberg Hearing Aid with Multi-Channel Compression CircuitESD · Traditional | Miracle-Ear, Inc. | 11/27/1996SE |
| K964511 | Unitron Model Sound F/Xd +4 (Sound F/Xd +4)ESD · Traditional | Unitron Industries, Inc. | 11/27/1996SE |
| K964510 | Unitron Model Icon Aohpd +4 (Icon Aohpd +4)ESD · Traditional | Unitron Industries, Inc. | 11/27/1996SE |
| K964508 | Unitron Model Icon Aohp +4 (Icon Aohp +4)ESD · Traditional | Unitron Industries, Inc. | 11/27/1996SE |
| K964504 | Unitron Model Icon Aohpl +4ESD · Traditional | Unitron Industries, Inc. | 11/27/1996SE |
| K964503 | Unitron Model Sound F/X +4ESD · Traditional | Unitron Industries, Inc. | 11/27/1996SE |
| K964502 | Unitron Model Sound F/Xp +4ESD · Traditional | Unitron Industries, Inc. | 11/27/1996SE |
| K964451 | Piccolo K-Amp Vc+, Piccolo P-A1, Piccolo P-Ao and Piccolo AtcESD · Traditional | Rexton, Inc. | 11/27/1996SE |
| K964244 | Starkey Custom Sequel Programmable and K Amp Programmable Air Conduction Hearing AidsESD · Traditional | Starkey Laboratories, Inc. | 11/27/1996SE |
| K964214 | Starkey A-13 Sequel Programmable, A-13 K-Amp Programmable Air Conduction Hearing AidsESD · Traditional | Starkey Laboratories, Inc. | 11/27/1996SE |
| K963875 | Ahs Omega K-AmpESD · Traditional | Authorized Hearing Systems, Inc. | 11/27/1996SE |
| K963788 | Primofocus CompactESD · Traditional | Oticon Corp. | 11/27/1996SE |
| K964180 | Audio 'D' Sound Selector Power (SSP)ESD · Traditional | Hearing Solutions, Inc. | 11/26/1996SE |
| K963881 | Ahs Delta 22 TESD · Traditional | Authorized Hearing Systems, Inc. | 11/26/1996SE |
| K963879 | Ahs Delta 22ESD · Traditional | Authorized Hearing Systems, Inc. | 11/26/1996SE |
| K963876 | Ahs Omega PPESD · Traditional | Authorized Hearing Systems, Inc. | 11/26/1996SE |
| K963874 | Ahs Omega AgcESD · Traditional | Authorized Hearing Systems, Inc. | 11/26/1996SE |
| K963873 | Ahs Omega DeqESD · Traditional | Authorized Hearing Systems, Inc. | 11/26/1996SE |
| K963745 | Model WMR Bte Hearing Instrument (Model WMR)ESD · Traditional | Hearing Innovations, Inc. | 11/26/1996SE |
| K963915 | Telex In-The-Ear Custom Hearing Aid with Threshold CompressionESD · Traditional | Telex Communications, Inc. | 11/08/1996SE |
| K964115 | Resound CC4 Personal Hearing SystemESD · Traditional | Resound Corp. | 11/04/1996SE |
| K963822 | Ovation AGC-3ESD · Traditional | Orsonique, Inc. | 10/28/1996SE |
| K963821 | Ovation AGC-1ESD · Traditional | Orsonique, Inc. | 10/28/1996SE |
| K963820 | Ovation LinearESD · Traditional | Orsonique, Inc. | 10/28/1996SE |
| K963819 | Ovation AspESD · Traditional | Orsonique, Inc. | 10/28/1996SE |
| K963818 | Ovation AGC-2ESD · Traditional | Orsonique, Inc. | 10/28/1996SE |
| K963604 | Dynamic Eq II - 2 Channel Wide Dynamic Range CompressionESD · Traditional | Midwest City Hearing Aid Center | 09/27/1996SE |
| K963519 | Euroline A-675 SerisESD · Traditional | Starkey Laboratories, Inc. | 09/27/1996SE |
| K963607 | Horizon 1 and 2 Programable Full Shell and in the CanalESD · Traditional | Midwest City Hearing Aid Center | 09/20/1996SE |
| K962388 | In the Ear Hearing AidESD · Traditional | Unique Hearing Technology, Inc. | 09/16/1996SE |
| K963047 | Air-Conduction Hearing Instruments: Models = 227, 229, 232, 216, 216P, 123, 219 (Modify)ESD · Traditional | Fenwick Hearing Instruments | 09/10/1996SE |
| K962798 | Audio 'D' K-Amp HR Full Shell and Canal Hearing AidsESD · Traditional | Hearing Solutions, Inc. | 09/09/1996SE |
| K963122 | Unitron Model Icon KRESD · Traditional | Unitron Industries, Inc. | 09/06/1996SE |
| K963154 | Rionet HB-54ASESD · Traditional | Authorized Hearing Systems, Inc. | 09/05/1996SE |
| K963153 | Rionet HB-55SESD · Traditional | Authorized Hearing Systems, Inc. | 09/05/1996SE |
| K963152 | Rionet HB-55ASESD · Traditional | Authorized Hearing Systems, Inc. | 09/05/1996SE |
| K962228 | Model Alpha Behind-The-Ear Hearing InstrumentESD · Traditional | Ototech Intl., Inc. | 08/28/1996SE |
| K962847 | MT10P, MT60-PP, MT60-AGC0, and MT60ESD · Traditional | Micro-Tech Hearing Instruments | 08/09/1996SE |
| K961770 | Philips 71 SeriesESD · Traditional | Philips Hearing Instruments Co. | 08/02/1996SE |
| K962170 | Siemens Vita 160 Series Pocket Hearing Instrument: Vita 162E,166M,168PPESD · Traditional | Siemens Hearing Instruments, Inc. | 07/25/1996SE |
| K961907 | Rionet Hearing Aid HB53-KESD · Traditional | Authorized Hearing Systems, Inc. | 07/03/1996SE |
| K961827 | In-The-EarESD · Traditional | Qualitone | 07/03/1996SE |
| K961729 | Argosy ProgrammableESD · Traditional | Argosy Electronics | 05/29/1996SE |
| K961653 | Phonak Sona P2ESD · Traditional | Phonak, Inc. | 05/29/1996SE |
| K961622 | Phonak PICONET2 P2 AzESD · Traditional | Phonak, Inc. | 05/17/1996SE |
| K961670 | ClarityESD · Traditional | Seig Technologies, Inc. | 05/14/1996SE |
| K961308 | Audio 'D' Intima CicESD · Traditional | Hearing Solutions, Inc. | 05/07/1996SE |
| K961143 | Telex Select 2-40 with Adaptive Compression S2-40ESD · Traditional | Telex Communications, Inc. | 05/07/1996SE |
| K961082 | Techna ToneESD · Traditional | Techna Tone | 05/07/1996SE |
| K961059 | Digifocus CompactESD · Traditional | Oticon, Inc. | 05/07/1996SE |
| K960741 | Comfortone PHSESD · Traditional | Comfortone America'S Value Hearing Aid Line | 05/07/1996SE |
| K961084 | Am 400ESD · Traditional | Electone, Inc. | 04/18/1996SE |
| K960684 | Hearing Aid - Air ConductionESD · Traditional | Resound Corp. | 04/10/1996SE |
| K960680 | Resound Personal Hearing Systems Edr Encore Series Models Edr-E, Edr-Es, Edr-Ev, & EDR-P1ESD · Traditional | Resound Corp. | 04/10/1996SE |
| K960804 | Miracle Ear & Audiotone Model Ite/Itc/CicESD · Traditional | Miracle-Ear, Inc. | 04/05/1996SE |
| K960410 | Perfect Ear Pe/Pe-Agc/Pe-B/Pe-PwrESD · Traditional | Perfect Ear | 04/04/1996SE |
| K960935 | Audio 'D' 2N Series Hearing Aids(Full Shell Ite,Half Shell Ite, Mini Canal, Canal)ESD · Traditional | Hearing Solutions, Inc. | 04/03/1996SE |
| K960295 | Long Life RX-12ESD · Traditional | Rexton, Inc. | 03/22/1996SE |
| K960052 | Resound Personal Hearing System BT2-ES, BT2-EV, & BT241ESD · Traditional | Resound Corp. | 03/12/1996SE |
| K960284 | Oticon /Primofocus (PF)ESD · Traditional | Oticon, Inc. | 03/07/1996SE |
| K960155 | Unitron Model Sound F/XpESD · Traditional | Unitron Industries, Inc. | 03/07/1996SE |
| K960031 | Audioflex 120ESD · Traditional | Maico Hearing Instruments, Inc. | 03/07/1996SE |
| K960494 | Euroline A312 Series of Behind the Ear Air Conduction Hearing AidsESD · Traditional | Starkey Laboratories, Inc. | 03/01/1996SE |
| K955930 | Beltone Composer 2000 Bte HPESD · Traditional | Beltone Electronics Corp. | 03/01/1996SE |
| K955879 | Widex Model Senso Digital (C16)ESD · Traditional | Widex Hearing Aid Co., Inc. | 02/27/1996SE |
| K955702 | Sonata U-01ESD · Traditional | Electone, Inc. | 02/22/1996SE |
| K955466 | Dynameq-Ii OptionESD · Traditional | Qualitone | 02/13/1996SE |
| K955878 | Widex Model Senso Digital (C8)ESD · Traditional | Widex Hearing Aid Co., Inc. | 02/12/1996SE |
| K955867 | Resound Personal Hearing System BT247ESD · Traditional | Resound Corp. | 02/02/1996SE |
| K955692 | Finetone FSC,ESD · Traditional | Finetone Hearing Instruments | 02/02/1996SE |
| K955288 | Hearing Aid Impression MaterialESD · Traditional | Crown Delta Corp. | 02/02/1996SE |
| K954119 | Miracle Ear MirageESD · Traditional | Miracle-Ear, Inc. | 01/24/1996SE |
| K954922 | Rexton's Horizion Family of Multiple Situation, Single Channel Programmbale InstrumentsESD · Traditional | Rexton, Inc. | 01/17/1996SE |
| K955574 | Resound Personal Hearing System BTP W/DaiESD · Traditional | Resound Corp. | 12/22/1995SE |
| K954941 | Miracle Ear and AudiotoneESD · Traditional | Miracle-Ear, Inc. | 12/22/1995SE |
| K955359 | Cyber III Option Um, UC312, UC10, UcicESD · Traditional | Qualitone | 12/19/1995SE |
| K954579 | Telex 349 Multi Cros W/Adapive CompressionESD · Traditional | Telex Communications, Inc. | 12/08/1995SE |
| K954936 | Beltone Ultima 80 Otosonic Power PasESD · Traditional | Beltone Electronics Corp. | 12/06/1995SE |
| K954236 | Faceplate (Hearing Aid Kit)ESD · Traditional | Truetone Hearing Systems, Inc. | 12/06/1995SE |
| K954937 | Coast Hearing CHS (Custom Hearing System)ESD · Traditional | Coast Hearing Services | 11/13/1995SE |
| K954794 | OticonESD · Traditional | Oticon, Inc. | 11/13/1995SE |
| K953603 | Hearing Today Hearing AidESD · Traditional | Hearing Today Laboratory, Inc. | 11/13/1995SE |
| K954526 | Widex Senso Digital (PX)ESD · Traditional | Widex Hearing Aid Co., Inc. | 10/18/1995SE |
| K954528 | Miracle - Ear Model PBPESD · Traditional | Miracle-Ear, Inc. | 10/07/1995SE |
| K954516 | Unitron Model Sound F/X IIESD · Traditional | Unitron Industries, Inc. | 10/07/1995SE |
| K953932 | Unitron Model Sound F/XdESD · Traditional | Unitron Industries, Inc. | 10/07/1995SE |
| K953727 | Unitron Model Ikon AohpdESD · Traditional | Unitron Industries, Inc. | 10/07/1995SE |
| K954430 | Unitron Model Sound F/XESD · Traditional | Unitron Industries, Inc. | 10/06/1995SE |
| K954067 | 3M Model 8295ESD · Traditional | 3M Company | 09/28/1995SE |
| K954054 | Maico Prodigy Cic SeriesESD · Traditional | Maico Hearing Instruments, Inc. | 09/28/1995SE |
| K954038 | K-Amp 16, Hi-Band K-Amp, Ultra Compression & Hearing Protection/Hearing InstrumentESD · Traditional | Argosy Electronics | 09/18/1995SE |
| K953921 | Phonak 9900 CicESD · Traditional | Phonak, Inc. | 09/18/1995SE |
| K953770 | Rexton Mini-Primo Plus, PP142, D.C .H.I. FamilyESD · Traditional | Rexton, Inc. | 09/18/1995SE |
| K951002 | Amendments to MultifocusESD · Traditional | Oticon A/S | 09/18/1995SE |
| K953960 | Hearing Aid (All-In-The-Ear)ESD · Traditional | Audina Hearing Instrument | 09/12/1995SE |
| K953729 | K Amp Full Shell and in the EarESD · Traditional | Midwest City Hearing Aid Center | 09/12/1995SE |
| K953728 | RX12 Linear Full Shell and in the CanalESD · Traditional | Midwest City Hearing Aid Center | 09/12/1995SE |
| K951712 | Hearing Aid (All-In-The-Ear)ESD · Traditional | Omega Hearing Aid Center | 09/12/1995SE |
| K953646 | Unitron Model Ikon AohplESD · Traditional | Unitron Industries, Inc. | 08/28/1995SE |
| K953631 | Snip Input Compression Class aESD · Traditional | Midwest City Hearing Aid Center | 08/28/1995SE |
| K953543 | 3M Model 8200P Multipro BteESD · Traditional | 3M Company | 08/23/1995SE |
| K945439 | Phonak Piconet 232X-AZ Hearing InstrumentESD · Traditional | Phonak, Inc. | 08/23/1995SE |
| K953050 | Z33ESD · Traditional | Electone, Inc. | 08/22/1995SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0584-2020 Class II | In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP…GN Hearing received reports from our manufacturing site in US regarding a software bug in our service &… | GN Hearing A/S | 09/18/2019Terminated |
| Z-0583-2020 Class II | Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW…GN Hearing received reports from our manufacturing site in US regarding a software bug in our service &… | GN Hearing A/S | 09/18/2019Terminated |
| Z-0094-2019 Class II | Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10…The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) battery drawer… | Widex A/S | 08/31/2018Terminated |
| Z-1681-2010 | InSound Medical, Inc, Lyric in-canal hearing aid.Manufacturing error could result in electrolyte leakage from the product's battery. | InSound Medical, Inc. | 01/19/2010Terminated |