Audina 153 Behind the Ear and Audina 158 Behind the Ear
FDA 510(k) K964816 · Audina Hearing Instrument
510(k) numberK964816
Submission
- Device name
- Audina 153 Behind the Ear and Audina 158 Behind the Ear
- Applicant
- Audina Hearing Instrument
Longwood, FL, US - Received
- November 29, 1996
- Decision date
- January 17, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ESD – Hearing Aid, Air-Conduction, Prescription
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.3300
- Specialty
- Ear, Nose, Throat
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.
Other 510(k)s with product code ESD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232999 | Lyric4 Hearing AidESD · Traditional | Sonova AG | 04/11/2024SE |
| K130790 | LYRIC2ESD · Traditional | Phonak, LLC | 06/27/2013SE |
| K081136 | Lyric Hearing AidESD · Traditional | Insound Medical, Inc. | 05/08/2008SE |
| K021867 | Insound XT Series Hearing AidESD · Traditional | Insound Medical, Inc. | 11/19/2002SE |
| K003558 | Tci Combi (Tinnitus Control Instrument Combination)ESD · Traditional | Siemens Hearing Instruments, Inc. | 04/24/2001SE |
| K984518 | Sonic Innovations Completely-In-The-Canal DSP Hearing Aid with Soft ShellESD · Traditional | Sonic Innovations, Inc. | 03/12/1999SE |
| K974751 | Tranquil Tri-Oe, Tranquil Tri-Coe, Tranquil Tri-CicESD · Traditional | General Hearing Instruments, Inc. | 03/06/1998SE |
| K974242 | Argosy Programmable OnqueESD · Traditional | Argosy Electronics | 01/20/1998SE |
| K973880 | Sonix Hearing Aid Fitting and Programming SystemESD · Traditional | Sonix Technologies, Inc. | 01/12/1998SE |
| K974211 | Opus 2 - Full Concha Series - IteESD · Traditional | Bernafon-Maico, Inc. | 12/15/1997SE |
More from Bernafon-Maico, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K953960 | Hearing Aid (All-In-The-Ear)ESD · Traditional | 09/12/1995SE |
| K942236 | Audina Prewires (Faceplate Hearing Aid Series)LRB · Traditional | 06/17/1994SE |
| K936190 | Behind the Ear Hearing AidESD · Traditional | 04/04/1994SE |
| K930271 | Behind-The-Ear Hearing AidESD · Traditional | 03/18/1993SE |
| K897024 | Model Audina Ite Heating AidESD · Traditional | 04/18/1990SE |
| K897023 | Oversight Program for In-Office Assembly, HRNG AidLRB · Traditional | 03/16/1990SE |
| K820833 | Audicraft Vip Hearing AidESD · Traditional | 04/09/1982SE |
Questions and answers
When was Audina 153 Behind the Ear and Audina 158 Behind the Ear cleared by the FDA?
Audina 153 Behind the Ear and Audina 158 Behind the Ear (K964816) received a 510(k) decision of Substantially Equivalent on January 17, 1997, 49 days after the submission was received.
What is the product code of K964816?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.