Product code LRB
- Device name
- Face Plate Hearing Aid
- 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
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974219 | FACEPLATE ASSEMBLY | Finetone Hearing Instruments | 1998-02-20 |
| K961593 | INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS | Segi Hearing Aid Co. | 1996-11-07 |
| K942722 | MODULE PROGRAM | Electone, Inc. | 1994-09-06 |
| K942236 | AUDINA PREWIRES (FACEPLATE HEARING AID SERIES) | Audina Hearing Instrument | 1994-06-17 |
| K935048 | ARTISAN PROGRAMMER & HEARING AID | Telex Communications, Inc. | 1994-02-09 |
| K933038 | GOLD AF MODULE, ITE | Electone, Inc. | 1993-08-02 |
| K933046 | SILVER L MODULE, ITE | Electone, Inc. | 1993-08-02 |
| K933045 | SILVER RECHARGEABLE MODULE, ITE | Electone, Inc. | 1993-08-02 |
| K933044 | SILVER LD MODULE, ITE | Electone, Inc. | 1993-08-02 |
| K933043 | SILVER PPP MODULE, ITE | Electone, Inc. | 1993-08-02 |
| K933040 | GOLD CD MODULE, ITE | Electone, Inc. | 1993-08-02 |
| K933039 | GOLD L MODULE, ITE | Electone, Inc. | 1993-08-02 |
| K933037 | GOLD K AMP, ITE | Electone, Inc. | 1993-08-02 |
| K910901 | FACEPLATE ITE HEARING AID MODEL 28A | Telex Communications, Inc. | 1991-05-30 |
| K910900 | FACEPLATE ITE HEARING AID MODEL TCA | Telex Communications, Inc. | 1991-05-30 |
| K897023 | OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID | Audina Hearing Instrument | 1990-03-16 |
| K896304 | OLYMPIA FACEPLATE MODULE | Olympia Instruments, Inc. | 1990-01-26 |
| K873031 | STARKEY MODEL P1 MODULE | Starkey Laboratories, Inc. | 1988-02-08 |
| K873300 | SERVICE MASTER (IMPULSE) | Richards Medical Co., Inc. | 1987-12-08 |
| K872645 | AIR CONDUCTION IN-THE-EAR HEARING AID UA/115/SCR | Richards Medical Co., Inc. | 1987-12-08 |
| K871884 | IN THE EAR & IN THE CANAL HEARING AID FACE PLATE | Hearing Services, Inc. | 1987-10-27 |
| K862769 | FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, FPR | Maico Hearing Instruments, Inc. | 1986-08-13 |
| K862768 | FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, MCA10 | Maico Hearing Instruments, Inc. | 1986-08-13 |
| K834479 | RELIABLE | Reliable Hearing Aide | 1984-07-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810126190895 | Audina | Audina Hearing Instruments, Inc. | 2023-01-27 |
| 00810126191038 | Audina | Audina Hearing Instruments, Inc. | 2023-01-27 |
| 00810126191021 | Audina | Audina Hearing Instruments, Inc. | 2023-01-27 |
| 00810126191014 | Audina | Audina Hearing Instruments, Inc. | 2023-01-27 |
| 00810126191007 | Audina | Audina Hearing Instruments, Inc. | 2023-01-27 |
| 00810126190994 | Audina | Audina Hearing Instruments, Inc. | 2023-01-27 |
| 00810126190987 | Audina | Audina Hearing Instruments, Inc. | 2023-01-27 |
| 00810126190970 | Audina | Audina Hearing Instruments, Inc. | 2023-01-27 |
| 00810126190963 | Audina | Audina Hearing Instruments, Inc. | 2023-01-27 |
| 00810126190956 | Audina | Audina Hearing Instruments, Inc. | 2023-01-27 |
| 00810126190949 | Audina | Audina Hearing Instruments, Inc. | 2023-01-27 |
| 00810126190932 | Audina | Audina Hearing Instruments, Inc. | 2023-01-27 |
| 00810126190925 | Audina | Audina Hearing Instruments, Inc. | 2023-01-27 |
| 00810126190918 | Audina | Audina Hearing Instruments, Inc. | 2023-01-27 |
| 00810126190901 | Audina | Audina Hearing Instruments, Inc. | 2023-01-27 |
| 00810126190888 | Audina | Audina Hearing Instruments, Inc. | 2023-01-27 |
| 00810126190871 | Audina | Audina Hearing Instruments, Inc. | 2023-01-27 |
| 00810126190864 | Audina | Audina Hearing Instruments, Inc. | 2023-01-27 |
| 00810126190857 | Audina | Audina Hearing Instruments, Inc. | 2023-01-27 |
| 00810126190840 | Audina | Audina Hearing Instruments, Inc. | 2023-01-27 |
| 00810126190741 | Audina | Audina Hearing Instruments, Inc. | 2023-01-26 |
| 00810126190833 | Audina | Audina Hearing Instruments, Inc. | 2023-01-26 |
| 00810126190826 | Audina | Audina Hearing Instruments, Inc. | 2023-01-26 |
| 00810126190819 | Audina | Audina Hearing Instruments, Inc. | 2023-01-26 |
| 00810126190802 | Audina | Audina Hearing Instruments, Inc. | 2023-01-26 |
| 00810126190796 | Audina | Audina Hearing Instruments, Inc. | 2023-01-26 |
| 00810126190789 | Audina | Audina Hearing Instruments, Inc. | 2023-01-26 |
| 00810126190772 | Audina | Audina Hearing Instruments, Inc. | 2023-01-26 |
| 00810126190765 | Audina | Audina Hearing Instruments, Inc. | 2023-01-26 |
| 00810126190758 | Audina | Audina Hearing Instruments, Inc. | 2023-01-26 |