What
is “the occlusion effect” and why is it a problem?
The occlusion effect is a common complaint of hearing aid wearers where the wearer’s voice sounds hollow, as if it were coming from the bottom of a barrel. Most people experience a very mild form of the occlusion effect when they have a cold and their ears get plugged up—their own voices sound much louder and unnatural.
What
is feedback in hearing aids and why is it a problem?
Feedback refers to the high-pitched squealing or whistling that hearing aids sometimes make. Feedback occurs when sound already amplified by the hearing aid leaks from the ear canal back to the hearing aid microphone. This can happen when the hearing aid is not positioned correctly or when it does not fit securely enough in the ear canal to maintain a complete seal, creating unwanted space between the device and the ear canal.
The presence of a high-pitched squealing noise can interfere with the ability to hear or participate in a conversation. In order to prevent feedback from occurring, tighter-fitting hearing aids or ear moulds are used to try to completely seal the ear canal. Because the ear canal changes shape when the mouth moves (for example, when talking, chewing, yawning, or laughing), achieving a complete seal is difficult. Feedback is often managed by reducing the amount of hearing aid gain (the amount of power the hearing aid creates to amplify sound). While reducing gain helps to reduce feedback, it also often results in certain sounds not being amplified enough, causing them to be missed completely by the hearing aid wearer.
Is
experience with hearing aids required before being considered
for the Carina Fully Implantable Hearing Device?
It is highly recommended that individuals who are considering the Carina Fully Implantable Hearing Device have experience with hearing aids. The Carina Fully Implantable Hearing Device is a medical device designed for adults with moderate to severe sensorineural hearing loss who have not been completely satisfied with and are seeking an alternative to hearing aids. Some individuals who experience infections or chronic irritation of the ear canal who can’t wear hearing aids may also benefit from the Carina Fully Implantable Hearing Device.
Is
the Carina Fully Implantable Hearing Device experimental?
No. Otologics has been developing, manufacturing, and implanting middle ear implants for seven years. Carina has completed rigorous trials in Europe and is now CE marked and commercially available. Clinical trials are underway in the United States. Otologics’ technology is based on over thirty years of research led by Dr. John M. Fredrickson, MD, PhD, a surgeon and researcher from the Washington University School of Medicine in St. Louis, Missouri.
How
does the Carina Fully Implantable Hearing Device differ from a
cochlear implant?
There are significant differences between Cochlear Implants and Middle Ear Implant’s. A Cochlear Implant requires an electrode to be implanted into the inner ear (the cochlea) of patients. This electrode stimulates the auditory nerve directly via electrical stimulation. Once an electrode has been inserted into the cochlea, the normal inner ear function of receiving and processing natural sound will be restricted.
On the other hand a Middle Ear Implant provides direct mechanical stimulation to the cochlea, yet without invading or opening the inner ear. The Middle Ear Implant stimulates with amplified “mechanical” sound, the follows the natural stimulation pathways. Should an Middle Ear Implant ever fail or become insufficient, then a Cochlear Implant (as a terminal therapy) would still be available.
A Cochlear Implant patient will have to learn the interpretation of the electrical stimulation that represents sounds, while a Middle Ear Implant patient will be provided with natural sounds, that does not require any re-learning.
Overall a Cochlear Implant is really intended for patients that are totally deaf, while a Middle Ear Implant will provide useful benefits to patients that still have residual (even if not much) hearing capability
What
are the various parts of the Carina Fully Implantable Hearing
Device?
The Carina Fully Implantable Hearing Device consists of only fully implantable components.
The implant, consists of three parts: a capsule that houses the electronics, a microphone system, and the Middle Ear Transducer™. The electronics capsule contains a battery, magnet, sound processor, and connector for the transducer. It is implanted under the skin behind the ear.
How
does the device work?
Sound is picked up by the microphone, processed, and sent to the Middle Ear Transducer. The transducer contains a motor that drives a tip that touches the middle ear anatomy. The movement of the tip against this anatomy causes the middle ear bone to move, just as sound waves cause the eardrum to vibrate and move the middle ear bones. Sound is processed from this point on just as it is when you hear normally.
How It Works Video.
How
much movement does the probe tip of the Carina Fully Implantable
Hearing Device cause?
When activated by sound signals, the probe tip of the Carina Fully Implantable Hearing Device moves in an in-and-out motion to vibrate the ossicles. The vibrations are very small: approximately 1-2 micrometers. Even under a high power microscope, it is impossible to actually see the movement of the probe tip.
Technology
changes so fast. Should I wait to be implanted?
The future of hearing is here. Just like any high tech product, future renovations will enhance its use, but today’s Carina is a fully featured product with state of the art technology in hearing technologies. Go get it!
Will the Carina Fully Implantable Hearing Device return my hearing to normal?
As with any middle ear implant or hearing aid, a hearing loss cannot be cured or restored to what you may think of as normal hearing. Because each person’s hearing loss and associated experiences are unique, the specific performance results and overall benefits may vary from individual to individual. It is important to recognize that the Carina Fully Implantable Hearing Device is intended to improve communication and to enhance quality of life. It will not restore an individual’s hearing to a completely natural, unaided state.
As with hearing aids, some individuals will do better than other individuals with the same type and degree of hearing loss. There is no test that can be administered to determine the degree of benefit an individual will experience with the Carina Fully Implantable Hearing Device. It is important to recognize that results vary and that some individuals may receive limited benefit. It is also important to realize that hearing in the presence of background noise is more difficult than hearing in a quiet environment. Individuals with normal hearing experience more difficulty hearing in a noisy environment than in a quiet one; for individuals with hearing loss, hearing in a noisy environment is even more difficult, with or without amplification. No device is capable of selectively eliminating background noise and amplifying only desired sounds such as speech. Reviewing and assessing realistic expectations with your surgeon and dispensing professional are important steps toward reaching the maximum potential for success, satisfaction, and benefit.
Will
I be able to participate in sports and other strenuous physical
activities?
The Carina Fully Implantable Hearing Device does not impose any restrictions on daily activities. In situations such as direct contact sports, precautions should be taken. Activities that may involve a blow to the head should be avoided. In other instances, it may be appropriate to wear headgear for additional protection. Participation in non-contact sports (such as tennis, golf, or running) is not restricted.
How
do I know if I am a candidate for this procedure?
Candidacy is determined through a joint effort between you and your middle ear implant team, which includes your surgeon and/or dispensing professional. Medical and audiological tests will assist in determining whether or not you are a potential candidate. The medical tests will include an ear examination to verify that there is no ear disease that might preclude implantation (such as otitis media). Other medical tests may be conducted to ensure that you are able to undergo surgery without risks to your general health. A series of hearing tests will be performed to document the type and degree of hearing loss in both of your ears. Your surgeon and/or dispensing professional will spend time with you to assess past and current amplification experience, educate you more on the device technology and associated procedures, and review realistic expectations to assist in determining candidacy.
Will I be able to have a Magnet Resonance Imaging (MRI)?
No. As with all middle ear and cochlear implants, the Carina Fully Implantable Hearing Device contains an internal magnet. Exposure to Magnetic Resonance Imaging is prohibited and may not be performed unless all implanted and external components are removed prior to test administration.
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