PMA P090018S027
- Device
- ESTEEM
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S027
- Product code
- OAF
- Decision date
- 2014-09-10
- Classification
- Implant, Hearing, Active, Middle Ear, Totally Implanted
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Approval order 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 DISCRIMINATION TEST SCORE GREATER THAN OR EQUAL TO 40%;5) NORMALLY FUNCTIONING EUSTACHIAN TUBE6) NORMAL MIDDLE EAR ANATOMY;7) NORMAL TYMPANIC MEMBRANE;8) ADEQUATE SPACE FOR ESTEEM IMPLANT DETERMINED VIA A HIGH RESOLUTION CT SCAN; AND 9) MINIMUM 30 DAYS OF EXPERIENCE WITH APPROPRIATELY FIT HEARING AIDS.
Current openFDA PMA Record#
- Device
- ESTEEM
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S027
- Product code
- OAF
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Decision date
- 2014-09-10
- Decision code
- APPR
- Date received
- 2014-06-12
- Supplement type
- Real-Time Process
- Approval order 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 DISCRIMINATION TEST SCORE GREATER THAN OR EQUAL TO 40%;5) NORMALLY FUNCTIONING EUSTACHIAN TUBE6) NORMAL MIDDLE EAR ANATOMY;7) NORMAL TYMPANIC MEMBRANE;8) ADEQUATE SPACE FOR ESTEEM IMPLANT DETERMINED VIA A HIGH RESOLUTION CT SCAN; AND 9) MINIMUM 30 DAYS OF EXPERIENCE WITH APPROPRIATELY FIT HEARING AIDS.