Esteem New Subject Enrollment Post Approval Study

Purpose:

To evaluate the long-term safety and efficacy of the Esteem Totally Implantable Hearing System (hereafter called Esteem) in subjects suffering from moderate to severe hearing loss.

Questions:

The following questions are to be answered:

• Is Esteem effective through 1 year follow-up?
• Is Esteem safe through 1 year follow-up?
• Is the incidence of facial paresis/paralysis at 1 month follow-up no greater than 7%?

Inclusion criteria

• Subject is ≥ 18 years old
• Subject understands the nature of the procedure and has signed the Subject Informed Consent Form prior to the procedure
• Subject is willing and able to comply with specified follow-up evaluations and understands the audiological test procedures and use of the Esteem® System.
• Subject has moderate to severe sensorineural hearing loss in the ear to be implanted defined by pure tone average air-conduction threshold level.
• Subject has an unaided maximum word recognition score of greater than or equal to 40% with recorded delivery using a phonetically balanced word list at SRT + 40 decibels (dB) or at maximum tolerable presentation level.
• Subject is a current user of a properly functioning and appropriately fit hearing aid for at least one (1) month in the ear to be implanted.
• Subject has normally functioning eustachian tube
• Subject has normal tympanic membrane
• Subject has a normal middle ear anatomy
• Subject has adequate space for Esteem® System implant determined via fine cut temporal bone CT scan
• Subject is a native speaker of the English language.

Exclusion criteria

• 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
• Subject has a history of otitis externa or eczema for the outer ear canal and the investigator believes this will affect the Esteem® System implantation
• Subject has cholesteatoma or destructive middle ear disease
• Subject has life expectancy of < two (2) years due to other medical conditions
• Subject has retrocochlear or central auditory disorders
• 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
• 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)
• Subject has sudden hearing loss due to unknown cause
• Subject has a history of disabling tinnitus, defined as tinnitus which required treatment.
• Subject is unable to adequately perform audiological testing
• 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.
• 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
• Subject is pregnant at the time of device implant
• Subject has a history of keloid formation
• Subject has known hypersensitivity to silicone rubber, polyurethane, stainless steel, titanium and/or gold