The Esteem® Hearing Implant Post Approval Study

Exclusion Criteria

• •Subjects will be excluded from the trial if any one of the following criteria is met:
• •1. Subject has a history of post-adolescent chronic middle ear infections, inner ear disorders or recurring vertigo requiring treatment, disorders such as mastoiditis, Hydrops or Meniere's syndrome or disease
• •2. Subject has a history of external otitis or eczema for the outer ear canal and the investigator believes this will affect the Esteem® System implantation
• •3. Subject has cholesteatoma or destructive middle ear disease
• •4. Subject has life expectancy of less than two (2) years due to other medical conditions
• •5. Subject has retrocochlear or central auditory disorders
• •6. Subject is known to be suffering from any psychological, developmental, physical, or emotional disorder that the investigator feels would interfere with the surgery or follow-up testing
• •7. Subject has a known history of fluctuating air conduction and/or bone conduction hearing loss over a one-year period of 15 dB in either direction at 2 or more frequencies (from 500 - 4000 Hz)
• •8. Subject has sudden hearing loss due to unknown cause
• •9. Subject has a history of disabling tinnitus, defined as tinnitus which required treatment.
• •10. Subject is unable to adequately perform audiological testing
• •11. Subject has a medical condition or undergoing a treatment that may affect healing and the investigator does not believe the subject is a good candidate for the trial.
• •12. Subject has diabetes that is not well controlled with medication or diet and the investigator does not believe in his best medical judgment that the subject would be a good candidate for the trial
• •13. Subject is pregnant at the time of device implant
• •14. Subject has a history of keloid formation
• •15. Subject has known hypersensitivity to silicone rubber, polyurethane, stainless steel, titanium and/or gold