Over-the-counter hearing aids are an alternative to prescription hearing aids, which are currently only available to hearing health professionals, such as audiologists. The FDA defines over-the-counter hearing aids as medical devices designed to treat mild to moderate hearing loss in adults 18 years of age or older. 4 They are classified separately from prescription hearing aids, and each has its own set of safety and efficacy standards. The important change in hearing health care is due to a recent change in regulations by the Food and Drug Administration, which in August paved the way for devices to be sold in retail stores without the need for shoppers to consult a doctor first.
In the past, the device itself only accounted for about one-third of what a person would spend to get a hearing aid. The rest of the price went to doctor appointments and other medical services, and Medicare and health insurance usually don't cover the cost of hearing aids. Learn more about the research supported by the NIDCD to make hearing health care more accessible and affordable. Making hearing health care more accessible and affordable is a public health priority, especially since the number of older adults in the U.S.
UU. The American Academy of Audiology, a professional organization of audiologists, published online information for consumers about over-the-counter hearing aids, and the American Hearing Loss Association, a consumer advocacy group, also offers online advice. Another factor that could drive demand for new devices is that the stigma of using a hearing aid is diminishing because people often use headphones to listen to music. It may need to be changed, since it's not clear if consumers will get in-store help selecting help without an audiologist.
De Wet Swanepoel, co-founder of HearX, said his Lexie Lumen OTC hearing aid will allow consumers to program it according to their needs. Before this legislation, consumers had to obtain a prescription from a licensed professional to purchase hearing aids. People with normal hearing often use PSAPs for recreational purposes, such as bird watching, to make all the sounds in the environment louder. Consumers could see over-the-counter hearing aids available at retail stores and traditional pharmacies in mid-October, when the rule takes effect.
More than 37 million American adults have hearing problems, and only 1 in 4 adults who could benefit from a hearing aid has used it, federal health authorities estimate. Therefore, a person may become discouraged when they don't get the successful outcome they expected and come to the (wrong) conclusion that hearing aids don't work for them, Kupfer said. Several over-the-counter companies offer an online hearing test or the ability to use the results of a previous in-person hearing test performed by an audiologist. The association also suggests that people consider whether the hearing aid requires the use of a smartphone to operate it and whether the battery is rechargeable or long lasting.
On the other hand, personal sound amplification products (PSAP), also known as hearing amplifiers or sound amplifiers, are not intended to be used as a treatment for hearing loss nor are they regulated by the FDA.