ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM
FDA premarket approval P090018 · decided 2010-03-17
Approval details
- PMA number
- P090018
- Trade name
- ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Applicant
- Envoy Medical Corporation
- Date received
- 2009-08-04
- Decision date
- 2010-03-17
- Days to decision
- 225 days
- Decision code
- APPR
- Product code
- OAF
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- Yes
- Location
- White Bear Lake, MN
- Statement
- APPROVAL FOR THE ESTEEM. THE ESTEEM IS INTENDED TO ALLEVIATE HEARING LOSS IN PATIENTS BY REPLICATING THE OSSICULAR CHAIN AND PROVIDING ADDITIONAL GAIN. THE ESTEEM IS INDICATED FOR PATIENTS WITH HEARING LOSS THAT MEET THE FOLLOWING CRITERIA: 1) 18 YEARS OF AGE OR OLDER;2) STABLE BILATERAL SENSORINEURAL HEARING LOSS;3) MODERATE TO SEVERE SENSORINEURAL HEARING LOSS DEFINED BY PURE TONE AVERAGE (PTA);4) UNAIDED SPEECH DISCRIMINATION TEST SCORE GREATER THAN OR EQUAL TO 40%;5) NORMALLY FUNCTIONING EUS
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ENVOYCEM, MODEL 1640 (K080032) | Envoy Medical Corporation | 2008-02-28 |