Oticon/Logic
FDA 510(k) K950381 · Oticon, Inc.
510(k) numberK950381
Submission
- Device name
- Oticon/Logic
- Applicant
- Oticon, Inc.
Somerset, NJ, US - Received
- January 31, 1995
- Decision date
- February 27, 1995
- 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.
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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 |
|---|---|---|
| K973886 | Oticon Digisound CompactESD · Traditional | 11/04/1997SE |
| K973885 | Oticon Digisound IteESD · Traditional | 11/04/1997SE |
| K964683 | Digifocus IteESD · Traditional | 12/12/1996SE |
| K963788 | Primofocus CompactESD · Traditional | 11/27/1996SE |
| K961059 | Digifocus CompactESD · Traditional | 05/07/1996SE |
| K960284 | Oticon /Primofocus (PF)ESD · Traditional | 03/07/1996SE |
| K954794 | OticonESD · Traditional | 11/13/1995SE |
| K946045 | OticonESD · Traditional | 01/30/1995SE |
| K933307 | Multifocus Compact Bte Hearing AidESD · Traditional | 08/23/1993SE |
| K932670 | Oticon MFESD · Traditional | 08/05/1993SE |
Questions and answers
When was Oticon/Logic cleared by the FDA?
Oticon/Logic (K950381) received a 510(k) decision of Substantially Equivalent on February 27, 1995, 27 days after the submission was received.
What is the product code of K950381?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.