Beltone Invisa
FDA 510(k) K940098 · Beltone Electronics Corp.
510(k) numberK940098
Submission
- Device name
- Beltone Invisa
- Applicant
- Beltone Electronics Corp.
Chicago, IL, US - Received
- January 10, 1994
- Decision date
- June 15, 1994
- 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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| 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 |
|---|---|---|
| K971852 | Air Conduction Haearing AidsESD · Traditional | 08/15/1997SE |
| K963958 | Impress, Perfecta, Acu-Form, and AcufitESD · Traditional | 12/05/1996SE |
| K955930 | Beltone Composer 2000 Bte HPESD · Traditional | 03/01/1996SE |
| K954936 | Beltone Ultima 80 Otosonic Power PasESD · Traditional | 12/06/1995SE |
| K943616 | Beltone Personal Hearing ScreenerEWO · Traditional | 07/12/1995SE |
| K951587 | Beltone Petite Plus Beltone Petite Plus Clearvioce KESD · Traditional | 06/30/1995SE |
| K952097 | Otosonic (Osi) CF 10-K, 10-DESD · Traditional | 06/28/1995SE |
| K950868 | Beltone Composer 2000ESD · Traditional | 06/28/1995SE |
| K946340 | Beltone ComparafitESD · Traditional | 04/13/1995SE |
| K944502 | Beltone Concerto SESD · Traditional | 10/20/1994SE |
Questions and answers
When was Beltone Invisa cleared by the FDA?
Beltone Invisa (K940098) received a 510(k) decision of Substantially Equivalent on June 15, 1994, 156 days after the submission was received.
What is the product code of K940098?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.