ESTEEM
FDA premarket approval P090018/S027 · decided 2014-09-10
Approval details
- PMA number
- P090018
- Supplement
- S027
- Supplement type
- Real-Time Process
- Trade name
- ESTEEM
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Applicant
- Envoy Medical Corporation
- Date received
- 2014-06-12
- Decision date
- 2014-09-10
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- OAF
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- White Bear Lake, MN
- Statement
- APPROVAL FOR CHANGES TO CAPACITANCE SPECIFICATIONS FOR THE ESTEEM SENSOR AND DRIVER COMPONENTS, AND THE ESTEEM SYSTEM IS INTENDED TO ALLEVIATE HEARING LOSS INPATIENTS 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 D
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ENVOYCEM, MODEL 1640 (K080032) | Envoy Medical Corporation | 2008-02-28 |