Over 35 million children and adults in the US have some degree of hearing loss, says the US Food and Drug Administration. Hearing loss can have a negative effect on communication, relationships, school/work performance, and emotional well-being.

However, hearing loss does not have to restrict your daily activities. Properly fitted hearing aids and aural rehabilitation (techniques used to identify and diagnose hearing loss, and implement therapies for patients who are hard of hearing, including using amplification devices to aid the patient's hearing abilities), can help in many listening situations. Aural rehabilitation helps a person focus on adjusting to his/her hearing loss and the use of hearing aids. It also explores assistive devices to help improve communication. Most people who are hearing-impaired will need two hearing aids as both ears may be affected, though some people may only need one hearing aid.

While the FDA regulates hearing aids, which are medical devices, it does not consider sound amplifiers to be medical devices when labelled for “recreational” or “other use”. However, certain safety regulations related to sound output levels still apply to these products.

Recently, the President's Council of Advisors on Science and Technology (PCAST), and the National Academies of Sciences, Engineering and Medicine (NAS) issued reports recommending ways to improve the access and affordability of hearing aids. This was followed up with a guidance from the FDA to communicate that it does not intend to enforce certain conditions for sale applicable to hearing aids for users 18 years of age or older.

Source: USFDA

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