| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | SOUNDTEC DIRECT SYSTEM |
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| Generic Name | Implant, hearing, active, middle ear, partially implanted |
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| Applicant | OTOTRONIX, LLC
26620 I-45 NORTH
HOUSTON, TX 77386 |
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| PMA Number | P010023 |
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| Date Received | 04/13/2001 |
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| Decision Date | 09/07/2001 |
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| Product Code |
MPV |
| Docket Number | 01M-0414 |
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| Notice Date | 09/20/2001 |
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| Advisory Committee |
Ear Nose & Throat |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order 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. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011
S012 S013 S014 |
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