Dahlberg Model JM In-The-Ear Hearing Instrument
FDA 510(k) K900862 · Miracle-Ear, Inc.
510(k) numberK900862
Submission
- Device name
- Dahlberg Model JM In-The-Ear Hearing Instrument
- Applicant
- Miracle-Ear, Inc.
Golden Valley, MN, US - Received
- February 23, 1990
- Decision date
- April 13, 1990
- 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 |
|---|---|---|
| K972346 | Miracle-Ear Ite DigitalESD · Traditional | 07/23/1997SE |
| K972345 | Dahlberg/Miracle-EarESD · Traditional | 07/23/1997SE |
| K972344 | Miracle-Ear Digital BteESD · Traditional | 07/23/1997SE |
| K970262 | Multi-Channel Compression Bte (SD)ESD · Traditional | 03/31/1997SE |
| K964419 | Miracle - Ear (Ite/Itc/Cic)ESD · Traditional | 02/04/1997SE |
| K965063 | Audiotone (A-552)ESD · Traditional | 01/27/1997SE |
| K965057 | Audiotone (A554H)ESD · Traditional | 01/27/1997SE |
| K965049 | Dahlberg (A-554)ESD · Traditional | 01/27/1997SE |
| K964669 | Miracle-Ear or AudiotoneESD · Traditional | 12/26/1996SE |
| K964794 | Dahlberg K-Amp BteESD · Traditional | 12/23/1996SE |
Questions and answers
When was Dahlberg Model JM In-The-Ear Hearing Instrument cleared by the FDA?
Dahlberg Model JM In-The-Ear Hearing Instrument (K900862) received a 510(k) decision of Substantially Equivalent on April 13, 1990, 49 days after the submission was received.
What is the product code of K900862?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.