K780309 is an FDA 510(k) clearance for the IN-THE-EAR HEARING AID, MODEL CE-3. This device is classified as a Hearing Aid, Air-conduction, Prescription (Class I - General Controls, product code ESD).
Submitted by Starkey Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 28, 1978, 5 days after receiving the submission on February 23, 1978.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3300. 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..
| 510(k) Number | K780309 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 1978 |
| Decision Date | February 28, 1978 |
| Days to Decision | 5 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | - |
| Product Code | ESD - Hearing Aid, Air-conduction, Prescription |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.3300 |
| Definition | 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. |