Opus 2 - Canal Series (Itc)
FDA 510(k) K974069 · Bernafon-Maico, Inc.
510(k) numberK974069
Submission
- Device name
- Opus 2 - Canal Series (Itc)
- Applicant
- Bernafon-Maico, Inc.
Eden Prairie, MN, US - Received
- October 28, 1997
- Decision date
- December 15, 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 |
|---|---|---|
| K982723 | Maico MA42EWO · Traditional | 10/28/1998SE |
| K981142 | Maico MA53EWO · Traditional | 04/22/1998SE |
| K974211 | Opus 2 - Full Concha Series - IteESD · Traditional | 12/15/1997SE |
| K974152 | Opus 2 - Completely-In-Canal Series (Cic)ESD · Traditional | 12/15/1997SE |
| K973948 | Dualine 100 BteESD · Traditional | 10/28/1997SE |
| K971158 | Dualine 400 CicESD · Traditional | 06/13/1997SE |
| K971080 | Maico MA52EWO · Traditional | 06/06/1997SE |
| K962275 | Maico MA25 Series II with SpeechEWO · Traditional | 09/05/1996SE |
Questions and answers
When was Opus 2 - Canal Series (Itc) cleared by the FDA?
Opus 2 - Canal Series (Itc) (K974069) received a 510(k) decision of Substantially Equivalent on December 15, 1997, 48 days after the submission was received.
What is the product code of K974069?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.