Heartech Model in Tech
FDA 510(k) K854315 · Hearing Tech, Inc.
510(k) numberK854315
Submission
- Device name
- Heartech Model in Tech
- Applicant
- Hearing Tech, Inc.
Minnetonka, MN, US - Received
- October 28, 1985
- Decision date
- January 21, 1986
- 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 |
|---|---|---|
| K941587 | Hearing TechESD · Traditional | 06/24/1994SE |
| K924712 | Rotablator Rotational Angioplasty SystemMCW · Traditional | 12/08/1992SE |
| K905680 | 543 Series BteESD · Traditional | 03/08/1991SE |
| K903295 | Escort ItcESD · Traditional | 09/05/1990SE |
| K903023 | Heritage III (HTC) Itc Type Hearing AidESD · Traditional | 07/27/1990SE |
| K870723 | Heartech HFX, Hearing AidESD · Traditional | 03/20/1987SE |
| K870350 | Escort Ec Custom In-The-Ear Hearing AidESD · Traditional | 03/11/1987SE |
| K853220 | Heartech Model IllusionESD · Traditional | 09/23/1985SE |
| K853219 | Heartech Model CHESD · Traditional | 09/23/1985SE |
| K853218 | Heartech Model(Htc) (Heritage)ESD · Traditional | 09/23/1985SE |
Questions and answers
When was Heartech Model in Tech cleared by the FDA?
Heartech Model in Tech (K854315) received a 510(k) decision of Substantially Equivalent on January 21, 1986, 85 days after the submission was received.
What is the product code of K854315?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.