Mar 18 2010
Esteem, an implanted system to treat sensorineural hearing loss of moderate to severe degree, has been approved by the U.S. Food and Drug Administration.
Esteem - implanted hearing system
Damage caused to the inner ear due to aging, noise, or viral infections and genetic factors result in sensorineural hearing loss, thus reducing the ability to comprehend speech and perceive sounds. Such a loss is different from conductive hearing loss that happens if sound waves are not able to transmit properly through the middle ear or outer ear or both. Often surgical or medical treatment can reinstate hearing in persons suffering from a conductive hearing loss that could have resulted due to a punctured eardrum, or the presence of earwax or fluid in the middle ear space.
The new hearing aid incorporates three implantable components, programming and external testing instruments. The implantable components are a sensor, a sound processor, and a driver. Mechanical vibrations from the middle ear bones and the eardrum are detected by the sensor and transformed into electrical signals that are transmitted to the sound processor. The processor then amplifies and filters the electrical signals so that hearing loss of the patient is compensated. The driver then transforms the amplified electrical signals back to mechanical vibrations that are then sent to the inner ear for perceiving them as sound.
The M.D., J.D., and director of the Center for Devices and Radiological Health of the FDA, Jeffrey Shuren, said that the FDA approval of the Esteem offers patients an opportunity to get relief from their hearing loss through a device that does not have easily noticeable external components.
The Esteem system design helps to alleviate the effects due to hearing loss in patients aged 18 years and above. Stable bilateral sensorineural hearing loss, intact middle ear anatomy, and a properly working Eustachian tube are some other conditions for the device to be used. The ability of Esteem to improve a patient’s hearing should be equivalent to that of traditional hearing aids.
During a multicenter study involving pre-implant versus Esteem hearing aids, it was found that 93% of patients with Esteem implants performed equally well or better in a speech intelligibility test compared to pre-implant hearing aids. During these tests, 7% of patients with Esteem scored less compared to patients with pre-implant aids, while 56% of Esteem implant patients performed better when compared to their own pre-implant aids.
Seven percent of the participants in the study had experienced facial paralysis, while 42% of these participants suffered from taste disturbance, and both experiences were caused by surgical procedure that was required for implanting the device. Most of these adverse problems were resolved in the one-year clinical study period.
The FDA approval has stipulated a condition that Envoy Medical Corporation of St. Paul, Minn., manufacturer of Esteem, has to perform two post-approval studies. In the first study, Envoy will have to continue follow-up on 61 subjects selected from the initial study for a duration of five years to analyze effectiveness and safety. The other study will be on 120 newly enrolled participants and will involve analyzing the occurrence of facial paralysis for a duration of one month after implantation, followed by the evaluation of effectiveness of Esteem after five years of implementation.
Source: http://www.fda.gov/