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The FDA has approved a hearing aid that consumers are able to program themselves. The Bose Hearing Aid, devised for adults with mild to moderate hearing loss, is the first self-fitting hearing aid to get the green light from the agency. It can be adjusted by users through an app on their smartphones and on the wireless device itself without the help of an audiologist.
In an announcement this month, the FDA reported that an analysis of studies of 125 patients who self-fit the hearing aid found that outcomes were “comparable on average to those with professional fitting of the same device.”
The announcement has caused some confusion, since many news reports have identified the Bose device as “the first over-the-counter hearing aid” — suggesting that consumers might now be able to pick up the device from a drugstore. The reality is more complicated: It is the first device that the FDA is allowing to be marketed at self-programmable, but the product “is not approved as an over-the-counter hearing aid,” says Catherine Palmer, director of audiology and hearing aids at the University of Pittsburgh Medical Center. “That is an actual class of devices that does not exist yet.”
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The FDA is still working on establishing regulations for an over-the-counter category of hearing aids, since Congress passed a bill in August of last year tasking the agency with doing so within three years. Until the process is complete, the FDA Reauthorization Act of 2017 (FDARA) states, “no products that are claimed to address hearing loss are, or can claim to be, OTC hearing aids.” Current state and federal laws require hearing aids to be purchased from “a licensed hearing aid dispenser.”
At least for the next few years, then, the Bose device will be available only through an audiologist or other licensed professional.
But even if one day you can buy a self-programmable hearing aid at your Walgreens or CVS without a hearing professional’s involvement — or, in the near term, purchase it from an audiologist without requiring their involvement otherwise — many consumers might still want to consult a professional rather than try to fit the device themselves, says Palmer: “For many people it’s time well spent to have that original appointment and have a full hearing evaluation so we really can get a full picture of how you hear and your communication needs.”
She also notes that a professional might be able to identify if the patient’s hearing loss is caused by something medically treatable; if so, an audiologist can “move them down the appropriate path to medical care.”
In some cases an audiologist might even recommend that the patient purchase a self-programmable hearing aid, Palmer says, and if the patient has trouble with it, he or she can return for fitting assistance. “The most exciting thing in all of this is that there are going to be multiple pathways to hearing health care,” she adds, “and that’s a good thing.”