The following data is part of a premarket notification filed by Telex Communications, Inc. with the FDA for Telex In-the-ear Custom Hearing Aid With Threshold Compression.
| Device ID | K963915 |
| 510k Number | K963915 |
| Device Name: | TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION |
| Classification | Hearing Aid, Air Conduction |
| Applicant | TELEX COMMUNICATIONS, INC. 9600 ALDRICH AVENUE SOUTH Minneapolis, MN 55420 |
| Contact | Tom Scheller |
| Correspondent | Tom Scheller TELEX COMMUNICATIONS, INC. 9600 ALDRICH AVENUE SOUTH Minneapolis, MN 55420 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-30 |
| Decision Date | 1996-11-08 |
| Summary: | summary |