Starkey Custom Sequel Programmable and K Amp Programmable Air Conduction Hearing Aids
FDA 510(k) K964244 · Starkey Laboratories, Inc.
510(k) numberK964244
Submission
- Device name
- Starkey Custom Sequel Programmable and K Amp Programmable Air Conduction Hearing Aids
- Applicant
- Starkey Laboratories, Inc.
Eden Prairie, MN, US - Received
- October 24, 1996
- Decision date
- November 27, 1996
- 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.
Other 510(k)s with product code ESD
| 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 |
|---|---|---|
| K201370 | Multiflex Tinnitus TechnologyKLW · Special | 06/19/2020SE |
| K122876 | Multiflex Tinnitus TechnologyKLW · Traditional | 10/31/2012SE |
| K030180 | Crescent Tinnitus Retaining Sound GeneratorKLW · Traditional | 09/17/2003SE |
| K970952 | Precise Impression KitESD · Traditional | 05/02/1997SE |
| K964245 | Precise, Tynmpanette, and Xacto Impression KitsESD · Traditional | 02/04/1997SE |
| K964340 | PORTAREM-3000, PFS-6000EWO · Traditional | 01/10/1997SE |
| K964216 | Starkey TM-3, TM-5 High Frequency Tinnitus MaskerKLW · Traditional | 12/06/1996SE |
| K964214 | Starkey A-13 Sequel Programmable, A-13 K-Amp Programmable Air Conduction Hearing AidsESD · Traditional | 11/27/1996SE |
| K963995 | Starkey MA-3 Air Conduction Combination Hearing Aid/Tinnitus MaskerKLW · Traditional | 11/26/1996SE |
| K963838 | Starkey TM Air Conduction Tinnitus MaskerKLW · Traditional | 11/26/1996SE |
Questions and answers
When was Starkey Custom Sequel Programmable and K Amp Programmable Air Conduction Hearing Aids cleared by the FDA?
Starkey Custom Sequel Programmable and K Amp Programmable Air Conduction Hearing Aids (K964244) received a 510(k) decision of Substantially Equivalent on November 27, 1996, 34 days after the submission was received.
What is the product code of K964244?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.