510(k) K964639
K964639 is an FDA 510(k) premarket notification submitted by Telex Communications, Inc. for the device "TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II". The FDA issued a decision of Substantially Equivalent on January 21, 1997. The device falls under product code ESD (Hearing Aid, Air-Conduction, Prescription), a Class I device regulated under 21 CFR 874.3300. Telex Communications, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 1997
- Date Received
- November 19, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hearing Aid, Air-Conduction, Prescription
- Device Class
- Class I
- Regulation Number
- 874.3300
- Review Panel
- EN
- Submission Type
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.