Series Star 66 Bekhind the Ear Hearing Aid
FDA 510(k) K931160 · Maico Hearing Instruments, Inc.
510(k) numberK931160
Submission
- Device name
- Series Star 66 Bekhind the Ear Hearing Aid
- Applicant
- Maico Hearing Instruments, Inc.
Minneapolis, MN, US - Received
- March 8, 1993
- Decision date
- June 1, 1993
- 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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| 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 |
|---|---|---|
| K960031 | Audioflex 120ESD · Traditional | 03/07/1996SE |
| K954054 | Maico Prodigy Cic SeriesESD · Traditional | 09/28/1995SE |
| K953161 | Maico MA630D Audiometer with Optional Reflex Decay & Eustachian Tube FunctionETY · Traditional | 07/24/1995SE |
| K950637 | Maico In-The-Ear Model RD-312 CicESD · Traditional | 03/21/1995SE |
| K946253 | Maico In-The-Ear Model RD 201ESD · Traditional | 01/30/1995SE |
| K931322 | KS 5 - Clinical AudiometerEWO · Traditional | 08/19/1994SE |
| K933291 | Maico Bte Model RD-111 and Ite Model RD-312 Hearing AidESD · Traditional | 08/23/1993SE |
| K930112 | Maico MA790 AudiometerEWO · Traditional | 08/05/1993SE |
| K926439 | MA25 - Portable Audiometer, ModificationEWO · Traditional | 08/05/1993SE |
| K931161 | Series Star 22 - Behind the Ear Hearing AidESD · Traditional | 06/01/1993SE |
Questions and answers
When was Series Star 66 Bekhind the Ear Hearing Aid cleared by the FDA?
Series Star 66 Bekhind the Ear Hearing Aid (K931160) received a 510(k) decision of Substantially Equivalent on June 1, 1993, 85 days after the submission was received.
What is the product code of K931160?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.