K935458 is an FDA 510(k) clearance for the AUDIPHON, MODEL H-11. This device is classified as a Hearing Aid, Air-conduction, Prescription (Class I - General Controls, product code ESD).
Submitted by National Hearing Aid Dist., Inc. (Boston, US). The FDA issued a Cleared decision on January 5, 1994, 54 days after receiving the submission on November 12, 1993.
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 | K935458 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 1993 |
| Decision Date | January 05, 1994 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| 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. |