FDA approves new hearing aids for high frequency hearing loss

Release date: 2016-09-21

Hearing problems have become a problem that has caused widespread concern in the medical community. This problem affects not only the growing elderly population, but also young people who are now keen to use a variety of headsets. According to the World Health Organization, there are currently more than 360 million people worldwide with disability hearing loss, and 32 million of them are children. At present, the output of hearing aids can only meet about 10% of the total demand. This situation has also spawned a huge market for medical devices. Recently, the US FDA approved the adoption of the hearing aid device Synchony EAS (electric acoustic stimulation) developed by MED-EL, which is expected to further expand the market.
        
         The EAS device combines a cochlear implant with an audio processor and is designed to treat patients with high or low frequency hearing loss. Patients with high-frequency hearing loss are unable to talk properly in noisy environments. The EAS system is capable of stimulating the cochlear nerve through a cochlear implant, while its accompanying audio processor can amplify the sound signal to assist the patient in making normal conversations. Raymond Gamble, the company's North American CEO, said the product can significantly reduce hearing difficulties in patients with high-frequency hearing impairment. Considering that there is currently no clinically available cochlear implant product that can effectively treat low-frequency hearing impairment, EAS equipment is expected to make up for it. A gap in the field.

         Clinical studies have shown that 92% of subjects have a significant improvement in hearing in a noisy environment after wearing the product. Patients using the EAS device scored twice as many in the conversational comprehension test as the control group. The FDA currently approves the product for the treatment of mild to moderate low frequency hearing impairment and severe high frequency hearing impairment over 18 years of age.

         Hearing loss is also called deafness or hearing level. It is the number of decibels in which the hearing threshold of the human ear is higher than the normal listening threshold. Hearing loss due to age is called senile deafness; hearing loss due to social environmental noise (except for age, occupational noise and disease) is called social deafness; hearing loss caused by occupational noise is called noise deaf. The World Health Organization (WHO) issued a new classification standard in 1997, adding a 4000 Hz hearing threshold to the previous standard to evaluate high-frequency hearing impairment.

Source: Bio Valley

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