SONATATI100 COCHLEAR IMPLANT
FDA premarket approval P000025/S021 · decided 2007-06-22
Approval details
- PMA number
- P000025
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SONATATI100 COCHLEAR IMPLANT
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2006-12-15
- Decision date
- 2007-06-22
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR THE SONATATI100 COCHLEAR IMPLANT AND IS INDICATED FOR THE FOLLOWING PATIENT POPULATIONS: ADULTS EIGHTEEN (18) YEARS OF AGE OR OLDER WHO HAVE BILATERAL, SENSORINEURAL HEARING IMPAIRMENT AND OBTAIN LIMITED BENEFIT FROM APPROPRIATELY FITTED BINAURAL HEARING AIDS. THESE INDIVIDUALS TYPICALLY DEMONSTRATE BILATERAL SEVERE TO PROFOUND SENSORINEURAL HEARING LOSS DETERMINED BY A PURE TONE AVERAGE OF 70 DB OR GREATER AT 500 HZ, 1000 HZ, AND 2000 HZ. LIMITED BENEFIT FROM AMPLIFICATION IS DEFIN
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