Resound ED4-M Mini-Canal Personal Hearing System W/Remote Control Option (Resound PHS ED4-M)
FDA 510(k) K951068 · Resound Corp.
510(k) numberK951068
Submission
- Device name
- Resound ED4-M Mini-Canal Personal Hearing System W/Remote Control Option (Resound PHS ED4-M)
- Applicant
- Resound Corp.
Redwood City, CA, US - Received
- March 8, 1995
- Decision date
- May 12, 1995
- 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.
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| 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 |
|---|---|---|
| K984547 | Digital Lgob Procedure Using Resound, Digital 5000 Series Hearing AidsEWO · Traditional | 03/19/1999SE |
| K974257 | Resound Digital 2000-BT W/Digital 2000-DF (Digital Programmer)ESD · Traditional | 12/12/1997SE |
| K974081 | Resound Stealth CicESD · Traditional | 12/12/1997SE |
| K971605 | Resound ED4 Personal Hearing System W/Remote Control OptionESD · Traditional | 07/03/1997SE |
| K970215 | Audallion II Hearing SystemESD · Traditional | 03/31/1997SE |
| K964557 | Resound BT4 Personal Hearing System W/Remote Control OptionESD · Traditional | 11/27/1996SE |
| K964115 | Resound CC4 Personal Hearing SystemESD · Traditional | 11/04/1996SE |
| K960684 | Hearing Aid - Air ConductionESD · Traditional | 04/10/1996SE |
| K960680 | Resound Personal Hearing Systems Edr Encore Series Models Edr-E, Edr-Es, Edr-Ev, & EDR-P1ESD · Traditional | 04/10/1996SE |
| K960052 | Resound Personal Hearing System BT2-ES, BT2-EV, & BT241ESD · Traditional | 03/12/1996SE |
Questions and answers
When was Resound ED4-M Mini-Canal Personal Hearing System W/Remote Control Option (Resound PHS ED4-M) cleared by the FDA?
Resound ED4-M Mini-Canal Personal Hearing System W/Remote Control Option (Resound PHS ED4-M) (K951068) received a 510(k) decision of Substantially Equivalent on May 12, 1995, 65 days after the submission was received.
What is the product code of K951068?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.