The following data is part of a premarket notification filed by Sonic Innovations, Inc. with the FDA for Sonic Innovations Completely-in-the-canal Dsp Hearing Aid With Soft Shell.
| Device ID | K984518 |
| 510k Number | K984518 |
| Device Name: | SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL |
| Classification | Hearing Aid, Air Conduction |
| Applicant | SONIC INNOVATIONS, INC. 5330 SOUTH 900 EAST, SUITE 240 Salt Lake City, UT 84117 |
| Contact | Jeannette S Johnson |
| Correspondent | Jeannette S Johnson SONIC INNOVATIONS, INC. 5330 SOUTH 900 EAST, SUITE 240 Salt Lake City, UT 84117 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-21 |
| Decision Date | 1999-03-12 |
| Summary: | summary |