The Canal (C.I.C.) Aka/Hidden Ear
FDA 510(k) K941107 · Qualitone, Inc.
510(k) numberK941107
Submission
- Device name
- The Canal (C.I.C.) Aka/Hidden Ear
- Applicant
- Qualitone, Inc.
Minneapolis, MN, US - Received
- March 7, 1994
- Decision date
- August 9, 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.
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 |
|---|---|---|
| K961827 | In-The-EarESD · Traditional | 07/03/1996SE |
| K955466 | Dynameq-Ii OptionESD · Traditional | 02/13/1996SE |
| K955359 | Cyber III Option Um, UC312, UC10, UcicESD · Traditional | 12/19/1995SE |
| K953884 | ProphetEWO · Traditional | 10/27/1995SE |
| K935348 | Odyssey Clinical AudiometerEWO · Traditional | 02/09/1994SE |
| K935289 | Pro Fit-Cyber II OptionESD · Traditional | 12/22/1993SE |
| K923006 | AS-90ESD · Traditional | 09/18/1993SE |
| K923007 | AT-2EWO · Traditional | 02/26/1993SE |
| K923986 | Cybernetic Option (Cyber I)ESD · Traditional | 09/10/1992SE |
| K923013 | Acoustic Appraise CD-3EWO · Traditional | 08/14/1992SE |
Questions and answers
When was The Canal (C.I.C.) Aka/Hidden Ear cleared by the FDA?
The Canal (C.I.C.) Aka/Hidden Ear (K941107) received a 510(k) decision of Substantially Equivalent on August 9, 1994, 155 days after the submission was received.
What is the product code of K941107?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.