| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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| Trade Name | SOUNDTEC DIRECT SYSTEM |
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| Classification Name | implant, hearing, active, middle ear, partially implanted |
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| Generic Name | implantable middle ear hearing device |
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| Applicant | OTOTRONIX, LLC |
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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 | |
| 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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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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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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| Supplements: |
S001 S002 S003 S004 S005 S006
S007 S008 S009 |
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