The difference between hearing aids and personal sound amplifiers

Nowadays many people have a hearing impairment. The wearing of hearing aids is becoming more and more common. But many people think that sound amplifiers are so-called hearing aids. Both hearing aids and personal sound amplifier (hearing aids) can improve our ability to hear the sound, but their products have different uses and are therefore subject to varying degrees of regulation. We're going to show you the difference today.

What's a hearing aid?

A hearing aid is a small loudspeaker that amplifies sounds that are not otherwise audible and uses the residual hearing of the hearing-impaired so that the sound can reach the brain's auditory center and sense the sound. It is mainly composed of a microphone, amplifier, headset, power supply, and volume control. According to the conduction mode, the hearing aid can be divided into the air-guided hearing aid and bone guided hearing aid. According to the usage mode, the hearing aid can be classified as box type, glasses type, hairpin type, back ear type, inner ear type, ear canal type, deep ear canal type hearing aid.

What is a personal sound amplifier?

The purpose of the personal sound amplifier (audiometer) is to expand the ambient sound effect and the user does not intend to compensate for impaired hearing and therefore does not require professional debugging. Personal hearing aids include watching TV, listening to lectures, and talking to family and friends.

Which is a medical device?

The Food and Drug Administration (FDA) states that hearing aids are "wearable devices or devices designed to compensate people with hearing impairment." This definition includes air conductive hearing aids and various types of bone-guided hearing aids (such as head-clamped and implantable hearing aids). All types of hearing aids are subject to different types of pre-market review requirements.
Hearing aids, which match the user's hearing loss in use, are classified as II devices in the management of medical devices, which must be subject to the supervision of the Drug Administration during their daily sales. You must obtain a sales license before you can sell.
In addition, the matching of hearing aids must be debugged by professional personnel, and the matching staff must receive appropriate training and pass the relevant examination to allow hearing aids to be fitted to people with hearing impairment. In order to ensure the effectiveness of hearing aid, it is necessary to evaluate the user's usage status after matching successfully.
Personal hearing aids are not used to diagnose, treat, cure or mitigate diseases, nor do they alter the structure or function of the body. They are not medical devices. Therefore, it is not regulated by the Food and Drug Administration (FDA).
If hearing aids are prescription drugs that require guidance and help from physicians, personal voice amplifiers are similar to self-help OTC over-the-counter drugs.

Price aspect

Hearing aids in the manufacturing design requirements are relatively high, plus the chip is set inside. The price is generally more expensive than a personal sound amplifier.
When the family members have hearing problems, they should go to a special hearing testing institution to check. What you need to do is not buy a listening aid at will. What you really need to do is go to a professional listening center to test your listening, start with a listening counselor, and listen to a professional listener's advice. Matching hearing aids are the best way for hearing loss patients make up for hearing loss!


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