ESD — Hearing Aid, Air-Conduction, Prescription Class I
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 |
| K974069 | bernafon-maico | OPUS 2 - CANAL SERIES (ITC) | December 15, 1997 |
| K974211 | bernafon-maico | OPUS 2 - FULL CONCHA SERIES - ITE | December 15, 1997 |
| K974152 | bernafon-maico | OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) | December 15, 1997 |
| K974129 | rockwin | HI-69E, HI-69N, HI-69P | December 12, 1997 |
| K974081 | resound | RESOUND STEALTH CIC | December 12, 1997 |
| K974257 | resound | RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) | December 12, 1997 |
| K974338 | unitron industries | UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) | 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 |
| 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 |