Interton Bte Hear Aid, Supra, Suprema, Minetta
FDA 510(k) K890525 · Magnatone Hearing Aid Corp.
510(k) numberK890525
Submission
- Device name
- Interton Bte Hear Aid, Supra, Suprema, Minetta
- Applicant
- Magnatone Hearing Aid Corp.
Casselberry, FL, US - Received
- February 2, 1989
- Decision date
- May 19, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K973861 | Futura 67M, 68M, MEGAPOWERMP97, Integra 70,71,72,73, Supra 51,52, Supra 56,57,58,59…ESD · Traditional | 11/19/1997SE |
| K973665 | Magnatone / Sterling/ ST; Magnatone/Db; Magnatone/ Liberty/ LB; Magnatone/ Pearl/Ph…ESD · Traditional | 11/04/1997SE |
| K944241 | Magnatone Model M Prewired Faceplate Hearing AidESD · Traditional | 11/16/1994SE |
| K911183 | NHS 2044P Body Aid, Hearing AidESD · Traditional | 07/09/1991SE |
| K911182 | NNHS 2050 Series (2055W-2054PP) Hearing AidsESD · Traditional | 05/09/1991SE |
| K911174 | NHS 2009SP Hearing AidESD · Traditional | 05/09/1991SE |
| K852656 | Model M Hearing AidESD · Traditional | 12/27/1985SE |
Questions and answers
When was Interton Bte Hear Aid, Supra, Suprema, Minetta cleared by the FDA?
Interton Bte Hear Aid, Supra, Suprema, Minetta (K890525) received a 510(k) decision of Substantially Equivalent on May 19, 1989, 106 days after the submission was received.
What is the product code of K890525?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.