The following data is part of a premarket notification filed by Cleartone Custom Hearing Instruments with the FDA for Cleartone Model-1 & 2 Hearing Aids.
| Device ID | K780459 |
| 510k Number | K780459 |
| Device Name: | CLEARTONE MODEL-1 & 2 HEARING AIDS |
| Classification | Hearing Aid, Air Conduction |
| Applicant | CLEARTONE CUSTOM HEARING INSTRUMENTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-23 |
| Decision Date | 1978-03-30 |