This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Esteem®
PMA Applicant: Envoy Medical Corporation
Address: 5000 Township Parkway, St. Paul, MN 55110
Approval Date: March 17, 2010
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf9/P090018a.pdf
What is it?
The Esteem® is the first totally implantable hearing system used to treat moderate to severe hearing loss caused by a defective inner ear function. The Esteem® system includes three implantable components (Sound Processor, Sensor, and Driver), and external testing and programming instruments.
How does it work?
The Sensor senses vibrations from the ear drum (tympanic membrane) and middle ear bones (ossicles) and converts these mechanical vibrations into electrical signals that are sent to the Sound Processor (see picture above). The Sound Processor receives the electrical signal from the Sensor, and amplifies and filters the signal to compensate for the individual patient’s hearing loss profile. The Driver converts the enhanced electrical signal received from the Sound Processor back to mechanical energy (vibrations). The vibrations are transmitted to the inner ear where they are perceived as sound. To implant the device, the Esteem® requires disruption of the normal middle ear structure (ossicular chain) by partially removing one of the bones (incus).
When is it used?
The Esteem® device is intended to reduce the effect of moderate to severe hearing loss in patients 18 years of age or older. The Esteem® is used in patients with hearing loss that meet the following criteria:
- Stable hearing loss caused by defective hair cells in the inner ear (sensorineural loss) in both ears
- Moderate to severe sensorineural hearing loss as defined by Pure Tone Average (PTA) at 500, 100, and 2000 hertz (Hz)
- Ability to understand what is heard (speech discrimination test score) greater than or equal to 40% of the words heard during the test.
- Normally functioning middle ear (Eustachian) tube
- Normal middle ear anatomy
- Normal tympanic membrane
- Adequate space for the Esteem® implant determined through a high resolution Computed Tomography (CT) scan
- Minimum 30 days of experience with appropriately fitted hearing aids
When should it not be used?
The Esteem® device should not be used under the following conditions: History of:
- post-adolescent chronic middle ear infections
- inner ear disorders or recurring vertigo requiring treatment
- disorders such as an infection of the mastoid bone (mastoiditis)
- swelling in the inner ear (hydrops)
- Meniere’s disease (a condition characterized by a ringing sound in the ear(s) or head [tinnitus], hearing loss, vertigo and a feeling of fullness in the ear)
- disabling tinnitus which requires treatment
- fluctuating air conduction and/or bone conduction hearing loss over the past one year period of 15 decibels (dB) in either direction at two or more hearing frequencies (from 500 to 4000 Hz)
- swimmer’s ear (otitis externa) or eczema of the outer ear canal
- destructive middle ear disease (cholesteatoma)
- central auditory disorders (retrocochlear)
- thick scar tissue that continues to grow (keloid formation)
- excessive sensitivity to silicone rubber, polyurethane, stainless steel, titanium and/or gold
- a pre-existing medical condition or undergoing a treatment that may affect the healing process
What will it accomplish?
The Esteem® is intended to improve hearing loss as well as a traditional hearing aid without any visible external components. The Esteem® uses an implanted battery that does not have to be recharged every day. The implanted battery has to be replaced in an outpatient surgical procedure under local anesthesia every 3-9 years depending on the number of hours the device is left on and the average noise level the user is exposed to each day.
A clinical study of this device involved 60 subjects at 3 investigational centers (57 were implanted with the device). The side-effects observed in the clinical study included:
- Taste disturbance: 42% of subjects (14% ongoing after 1 year)
- Facial paresis (partial paralysis) / paralysis: 7% of subjects (1% ongoing after 1 year)
- Tinnitus: 18% of subjects* (5% ongoing after 1 year) * Some subjects reported having tinnitus prior to the Esteem® implant.
Additional information: Summary of Safety and Effectiveness and labeling are available online.