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 | April 11, 2024 |
| K130790 | phonak | LYRIC2 | June 27, 2013 |
| K081136 | insound medical | LYRIC HEARING AID | May 8, 2008 |
| K021867 | insound medical | INSOUND XT SERIES HEARING AID | November 19, 2002 |
| K003558 | siemens hearing instruments | TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | April 24, 2001 |
| K984518 | sonic innovations | SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL | March 12, 1999 |
| K974751 | general hearing instruments | TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC | March 6, 1998 |
| K974242 | argosy electronics | ARGOSY PROGRAMMABLE ONQUE | January 20, 1998 |
| K973880 | sonix technologies | SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM | January 12, 1998 |
| K974211 | bernafon-maico | OPUS 2 - FULL CONCHA SERIES - ITE | December 15, 1997 |
| K974069 | bernafon-maico | OPUS 2 - CANAL SERIES (ITC) | December 15, 1997 |
| K974152 | bernafon-maico | OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) | December 15, 1997 |
| K974257 | resound | RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) | December 12, 1997 |
| K974340 | unitron industries | UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE | December 12, 1997 |
| K974339 | unitron industries | UNITRON MODEL SOUND F/XD PROGRAMMABLE | December 12, 1997 |
| K974338 | unitron industries | UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) | December 12, 1997 |
| K974129 | rockwin | HI-69E, HI-69N, HI-69P | December 12, 1997 |
| K974081 | resound | RESOUND STEALTH CIC | December 12, 1997 |
| K973927 | hyunjae | HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL | December 11, 1997 |
| K973861 | magnatone hearing aid | FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58 | November 19, 1997 |