Many people with trouble hearing have never used hearing aids. About 30 million U.S. citizens have hearing loss in both ears, and estimates show that many hard-of-hearing people who could benefit from hearing aids have never used them. Only thirty percent of individuals aged 70 and sixteen percent aged 20 to 69 years with impaired hearing have hardly used a hearing aid. Their hearing impairment affects their social and family life. In the past, hearing aid implantation was not an easy task due to the high cost and low beneficial hopes.
Further, the insurance companies don't pay for regular hearing tests, and the people have to pay for the examination of their hearing ability. Therefore, the FDA decided to provide hearing aids at the drugstore without a prescription. The people will save their expenses on hearing aid evaluation, i.e., $2800. The availability of over-the-counter hearing aid will facilitate individuals in their communication and solve daily life problems.
The U.S. Food and Drug Administration put out a final rule to make hearing aids easier. This creates a new category of over-the-counter (OTC) hearing aids that can be bought directly from the market by people who think they have mild to moderate hearing loss. The rule will be applied, and the OTC hearing aids could be sold in local pharmacies. After reading more than 1,000 comments from the public, the FDA has reached the best guideline on over-the-counter (OTC) hearing aids. Hearing aids that can be bought without a prescription are available for 18 years old and older who think they have mild hearing loss. Hearing aids that don't meet the criteria to be sold over-the-counter (OTC) need a prescription. In addition, the law makes a few changes from the proposed rule, such as reducing the highest audio output to ensure that too much sound doesn't hurt people's hearing.
According to Lewis, OTC (over-the-counter) hearing aids are helpful for individuals with good hearing power when it's quiet but face problems in hearing when there is noise in the background. This kind of OTC hearing aid doesn't require evaluation. However, individuals with severe hearing loss must have a hearing evaluation by an audiologist before using an OTC aid.
The FDA's final law will be applicable in mid-October 2022. But still, many prerequisites need to be checked before the final availability of aids, such as maximum hearing output, the inserting position of the aid deep in the ear canal, user-friendly volume control, and instructions for using the aid.
Edited by: Ayona Mitra
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