Over the counter (OTC) hearing aids will soon be available in “big box” department stores, like Walmart and Costco, thanks to legislation signed in 2017.


At the time, Congress directed the FDA to develop regulations for over-the-counter hearing aids. While stalled for many reasons, President Biden has just directed the FDA to issue the proposed rules in the next 120 days.


These OTC instruments are not to be confused with existing hearing aids, which are considered medical grade devices and are already regulated by the FDA. Instead, the OTC hearing aids are designed for people with mild to moderate hearing loss, and do not have to be fitted by a medical professional.


Over The Counter Hearing Aids Are Basic, Standard, Limited


Janet Revelle, AuD, said that the aim of the legislation is to make hearing care more accessible and affordable, which she and her fellow audiologists support. But she stresses that the OTC hearing aids are most often basic standard amplifiers with limited features. “They are like eyeglass ‘cheaters.’ If you think of them as ‘starter’ hearing aids, and if they help people recognize the benefit of hearing care, then they serve a purpose,” she said. “Especially if it leads them to seek a qualified professional to address individual needs.”


Understandably, the American Speech Language Association (ASHA) expressed concerns about the executive order. According to ASHA’s website, “A person with moderate to profound hearing loss needs to seek the services of a hearing health professional, such as an audiologist, and the proper technology customized to compensate and correct for that person’s hearing impairment. Audiologists are trained to assess medically treatable causes of hearing loss and to ensure that any technology used to assist with hearing loss is appropriate or safely customized for each individual patient.”


Janet agrees. “People who have challenging listening and lifestyle needs – such as a banquet server in a noisy restaurant – will not be well served with over the counter devices.”


To bring the cost down, manufacturers have de-featured them, removing some of the advanced technology that makes the FDA approved hearing instruments offered by hearing care professionals so precise and effective. The cost covers only the devices, not any service or training for use, care and maintenance.


“OTC instruments serve an immediate need for patients with minimal hearing needs and limited resources,” said Janet. “But there is no substitute for the skill and experience of a doctor of audiology when your hearing healthcare needs are at stake.”






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