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.
| Device | 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 |
| Notice Date | 2001-09-20 |
| PMA | P010023 |
| Supplement | S |
| Product Code | MPV |
| Docket Number | 01M-0414 |
| Advisory Committee | Ear Nose & Throat |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | OTOTRONIX, LLC 26620 I-45 North houston, TX 77386 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P010023 | | Original Filing |
| S014 |
2020-09-28 |
30-day Notice |
| S013 |
2015-09-15 |
135 Review Track For 30-day Notice |
| S012 |
2015-09-09 |
Normal 180 Day Track No User Fee |
| S011 |
2014-05-29 |
Normal 180 Day Track |
| S010 |
2013-06-13 |
Real-time Process |
| S009 |
2011-04-27 |
135 Review Track For 30-day Notice |
| S008 |
2010-12-21 |
30-day Notice |
| S007 |
2010-10-25 |
Normal 180 Day Track |
| S006 |
2010-09-15 |
Normal 180 Day Track No User Fee |
| S005 |
2010-07-27 |
Normal 180 Day Track No User Fee |
| S004 |
2010-07-07 |
Normal 180 Day Track |
| S003 |
2010-05-18 |
135 Review Track For 30-day Notice |
| S002 |
2009-08-19 |
Normal 180 Day Track No User Fee |
| S001 |
2001-11-21 |
Normal 180 Day Track |
NIH GUDID Devices