Product code ESD
- Device name
- Hearing Aid, Air-Conduction, Prescription
- Medical specialty
- Ear, Nose, Throat
- Device class
- 1
- Regulation number
- 874.3300
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232999 | Lyric4 Hearing Aid | Sonova AG | 2024-04-11 |
| K130790 | LYRIC2 | Phonak, LLC | 2013-06-27 |
| K081136 | LYRIC HEARING AID | Insound Medical, Inc. | 2008-05-08 |
| K021867 | INSOUND XT SERIES HEARING AID | Insound Medical, Inc. | 2002-11-19 |
| K003558 | TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | Siemens Hearing Instruments, Inc. | 2001-04-24 |
| K984518 | SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL | Sonic Innovations, Inc. | 1999-03-12 |
| K974751 | TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC | General Hearing Instruments, Inc. | 1998-03-06 |
| K974242 | ARGOSY PROGRAMMABLE ONQUE | Argosy Electronics | 1998-01-20 |
| K973880 | SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM | Sonix Technologies, Inc. | 1998-01-12 |
| K974211 | OPUS 2 - FULL CONCHA SERIES - ITE | Bernafon-Maico, Inc. | 1997-12-15 |
| K974152 | OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) | Bernafon-Maico, Inc. | 1997-12-15 |
| K974069 | OPUS 2 - CANAL SERIES (ITC) | Bernafon-Maico, Inc. | 1997-12-15 |
| K974340 | UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE | Unitron Industries, Inc. | 1997-12-12 |
| K974339 | UNITRON MODEL SOUND F/XD PROGRAMMABLE | Unitron Industries, Inc. | 1997-12-12 |
| K974338 | UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) | Unitron Industries, Inc. | 1997-12-12 |
| K974257 | RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) | Resound Corp. | 1997-12-12 |
| K974129 | HI-69E, HI-69N, HI-69P | Rockwin Corp. | 1997-12-12 |
| K974081 | RESOUND STEALTH CIC | Resound Corp. | 1997-12-12 |
| K973927 | HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL | Hyunjae Corp. | 1997-12-11 |
| K973861 | FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48 | Magnatone Hearing Aid Corp. | 1997-11-19 |
| K973972 | PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER) | Perfect Ear | 1997-11-04 |
| K973886 | OTICON DIGISOUND COMPACT | Oticon, Inc. | 1997-11-04 |
| K973885 | OTICON DIGISOUND ITE | Oticon, Inc. | 1997-11-04 |
| K973665 | MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER | Magnatone Hearing Aid Corp. | 1997-11-04 |
| K973846 | AIR CONDUCTION HEARING AID | Baron Trading, Inc. | 1997-10-29 |
| K973948 | DUALINE 100 BTE | Bernafon-Maico, Inc. | 1997-10-28 |
| K973579 | AM SERIES HEARING AID | A & M Hearing, Ltd. | 1997-10-28 |
| K973043 | MODEL C-1 HEARING AID | Better Hearing, Inc. | 1997-10-27 |
| K972818 | D72 DIGITAL | Philips Hearing Instruments Co. | 1997-10-17 |
| K973376 | LORI/LORI, LORI-S (LORI STOCK AID) | Lori Medical Laboratories, Inc. | 1997-10-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613389772937 | MEMINI I 3 5P CIC-10 NWL PH | Sonova AG | 2024-11-12 |
| 07613389772920 | MEMINI I 4 5P CIC-10 NWL PH | Sonova AG | 2024-11-12 |
| 07613389772845 | ampli-mini I 2 5P CIC-10 NWL PH | Sonova AG | 2024-11-12 |
| 07613389772838 | ampli-mini I 3 5P CIC-10 NWL PH | Sonova AG | 2024-11-12 |
| EPRCA0032900 | otosil ES-1.1 | pro3dure medical GmbH | 2022-09-15 |
| 16945936700307 | Newsound | Xiamen New Sound Technology Co., Ltd. | 2020-12-31 |
| 16945936700222 | Newsound | Xiamen New Sound Technology Co., Ltd. | 2020-12-31 |
| 16945936700246 | Newsound | Xiamen New Sound Technology Co., Ltd. | 2020-12-31 |
| 16945936700130 | Newsound | Xiamen New Sound Technology Co., Ltd. | 2020-10-14 |
| 16945936700147 | Newsound | Xiamen New Sound Technology Co., Ltd. | 2020-10-14 |
| 07630034363319 | UNITRON | Unitron Hearing Ltd | 2018-02-28 |
| 07630034363265 | UNITRON | Unitron Hearing Ltd | 2018-02-28 |
| 07630034363258 | UNITRON | Unitron Hearing Ltd | 2018-02-28 |
| 07630034363203 | UNITRON | Unitron Hearing Ltd | 2018-02-28 |
| 07630034363197 | UNITRON | Unitron Hearing Ltd | 2018-02-28 |
| 07630034362947 | UNITRON | Unitron Hearing Ltd | 2018-02-28 |
| 07630034363142 | UNITRON | Unitron Hearing Ltd | 2018-02-28 |
| 07630034363135 | UNITRON | Unitron Hearing Ltd | 2018-02-28 |
| 07630034363029 | UNITRON | Unitron Hearing Ltd | 2018-02-28 |
| 07630034363005 | UNITRON | Unitron Hearing Ltd | 2018-02-28 |
| 07630034362893 | UNITRON | Unitron Hearing Ltd | 2018-02-28 |
| 07630034362824 | UNITRON | Unitron Hearing Ltd | 2018-02-28 |
| 07630034362794 | UNITRON | Unitron Hearing Ltd | 2018-02-28 |
| 07630034362749 | UNITRON | Unitron Hearing Ltd | 2018-02-28 |
| 07630034362732 | UNITRON | Unitron Hearing Ltd | 2018-02-28 |
| 07613275628843 | Phonak | Sonova AG | 2017-08-24 |
| 07613275553039 | Phonak | Sonova AG | 2017-08-24 |
| 07613275553022 | Phonak | Sonova AG | 2017-08-24 |
| 07613275553015 | Phonak | Sonova AG | 2017-08-24 |
| 07613275553008 | Phonak | Sonova AG | 2017-08-24 |