SOUNDTEC DIRECT SYSTEM
FDA premarket approval P010023 · decided 2001-09-07
Approval details
- PMA number
- P010023
- Trade name
- SOUNDTEC DIRECT SYSTEM
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Applicant
- Ototronix, LLC
- Date received
- 2001-04-13
- Decision date
- 2001-09-07
- Days to decision
- 147 days
- Decision code
- APPR
- Product code
- MPV
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR THE SOUNDTEC(R) DIRECT SYSTEM. THIS DEVICE IS INDICATED FOR USE IN ADULTS, 18 YEARS OF AGE OR OLDER, WHO HAVE A MODERATE TO SEVERE SENSORINEURAL HEARING LOSS AND DESIRE AN ALTERNATIVE TO AN ACOUSTIC HEARING AID. PRIOR TO RECEIVING THE DEVICE, IT IS RECOMMENDED THAT AN INDIVIDUAL HAVE EXPERIENCE WITH APPROPRIATELY FIT HEARING AIDS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PROCEM (K140644) | Ototronix, LLC | 2014-06-19 |
| NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM (K130201) | Ototronix, LLC | 2013-04-26 |