K922066 is an FDA 510(k) clearance for the TELEX MODEL 28A ITE CUSTOM HEARING AID. This device is classified as a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD).
Submitted by Telex Communications, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 18, 1992, 14 days after receiving the submission on May 4, 1992.
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 | K922066 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 1992 |
| Decision Date | May 18, 1992 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| 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. |