510(k) K951896
K951896 is an FDA 510(k) premarket notification submitted by Siemens Hearing Instruments, Inc. for the device "INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT". The FDA issued a decision of Substantially Equivalent on May 30, 1995. The device falls under product code ESD (Hearing Aid, Air-Conduction, Prescription), a Class I device regulated under 21 CFR 874.3300. Siemens Hearing Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 1995
- Date Received
- April 24, 1995
- 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.