ESD — Hearing Aid, Air-Conduction, Prescription Class I
FDA product code ESD covers "Hearing Aid, Air-Conduction, Prescription", a Class I medical device regulated under 21 CFR 874.3300. Submissions are reviewed by the Ear, Nose, Throat panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ESD
- Device Class
- Class I
- Regulation Number
- 874.3300
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232999 | Sonova | Lyric4 Hearing Aid | Apr 11, 2024 |
| K130790 | Phonak | LYRIC2 | Jun 27, 2013 |
| K081136 | Insound Medical | LYRIC HEARING AID | May 8, 2008 |
| K021867 | Insound Medical | INSOUND XT SERIES HEARING AID | Nov 19, 2002 |
| K003558 | Siemens Hearing Instruments | TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | Apr 24, 2001 |
| K984518 | Sonic Innovations | SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL | Mar 12, 1999 |
| K974751 | General Hearing Instruments | TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC | Mar 6, 1998 |
| K974242 | Argosy Electronics | ARGOSY PROGRAMMABLE ONQUE | Jan 20, 1998 |
| K973880 | Sonix Technologies | SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM | Jan 12, 1998 |
| K974211 | Bernafon-Maico | OPUS 2 - FULL CONCHA SERIES - ITE | Dec 15, 1997 |
| K974069 | Bernafon-Maico | OPUS 2 - CANAL SERIES (ITC) | Dec 15, 1997 |
| K974152 | Bernafon-Maico | OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) | Dec 15, 1997 |
| K974257 | Resound | RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) | Dec 12, 1997 |
| K974340 | Unitron Industries | UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE | Dec 12, 1997 |
| K974339 | Unitron Industries | UNITRON MODEL SOUND F/XD PROGRAMMABLE | Dec 12, 1997 |
| K974338 | Unitron Industries | UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) | Dec 12, 1997 |
| K974129 | Rockwin | HI-69E, HI-69N, HI-69P | Dec 12, 1997 |
| K974081 | Resound | RESOUND STEALTH CIC | Dec 12, 1997 |
| K973927 | Hyunjae | HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL | Dec 11, 1997 |
| K973861 | Magnatone Hearing Aid | FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58 | Nov 19, 1997 |