510(k) K971399
K971399 is an FDA 510(k) premarket notification submitted by General Hearing Instruments, Inc. for the device "AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC". The FDA issued a decision of Substantially Equivalent on June 13, 1997. The device falls under product code ESD (Hearing Aid, Air-Conduction, Prescription), a Class I device regulated under 21 CFR 874.3300. General Hearing Instruments, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 1997
- Date Received
- April 15, 1997
- 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.