Auris Ae, Auris TL, Auris HS, Auris Ac, Auris MM, Auris Coe, Auris Cic
FDA 510(k) K971399 · General Hearing Instruments, Inc.
510(k) numberK971399
Submission
- Device name
- Auris Ae, Auris TL, Auris HS, Auris Ac, Auris MM, Auris Coe, Auris Cic
- Applicant
- General Hearing Instruments, Inc.
Harahan, LA, US - Received
- April 15, 1997
- Decision date
- June 13, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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.
Questions and answers
When was Auris Ae, Auris TL, Auris HS, Auris Ac, Auris MM, Auris Coe, Auris Cic cleared by the FDA?
Auris Ae, Auris TL, Auris HS, Auris Ac, Auris MM, Auris Coe, Auris Cic (K971399) received a 510(k) decision of Substantially Equivalent on June 13, 1997, 59 days after the submission was received.
What is the product code of K971399?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.