Behind the Ear Hearing Aid
FDA 510(k) K936190 · Audina Hearing Instrument
510(k) numberK936190
Submission
- Device name
- Behind the Ear Hearing Aid
- Applicant
- Audina Hearing Instrument
Casselberry, FL, US - Received
- December 27, 1993
- Decision date
- April 4, 1994
- 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 |
|---|---|---|
| K964816 | Audina 153 Behind the Ear and Audina 158 Behind the EarESD · Traditional | 01/17/1997SE |
| K953960 | Hearing Aid (All-In-The-Ear)ESD · Traditional | 09/12/1995SE |
| K942236 | Audina Prewires (Faceplate Hearing Aid Series)LRB · Traditional | 06/17/1994SE |
| 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 Behind the Ear Hearing Aid cleared by the FDA?
Behind the Ear Hearing Aid (K936190) received a 510(k) decision of Substantially Equivalent on April 4, 1994, 98 days after the submission was received.
What is the product code of K936190?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.